Re: etude d'enregistrement = clinical trial?

[Guest guest]

Hi again, Marla.

Have you excluded " registration trials " ?

At 10:34 18-05-01 -0400, you wrote:

>Thanks for your comments, Coilín, Barbara and François.

>

>I'm still looking, but it appears that I was led astray by a false

>cognate -- i.e., there *is* such thing as " registration studies " in

>English, but I've come to realize that it doesn't mean the same

>thing as " études d'enregistrement " in French.

What have I missed?

>As per François and other French sources, " études d'enregistrement "

>are basically what Barbara suggested, " studies to support drug

>registration " .

And I thought I had established that this was the definition of

" registration trials " . Have I misunderstood something?

>However, that phrase is kind of long for my context --

>I wonder if I could just use " clinical trials " , or is that too specific?

>( " Clinical trials " only refers to trials in humans AFAIK,

>and there

>are of course earlier studies done in animals which are " in support of "

>the drug registration process

I _think_ these should be called preclinical tests, and the term clinical

trials reserved for trials with patients.

But there may be some clinical trials that are not registration clinical

trials - e.g. if we want to establish whether drug X, already registered as

an antihypertensive medication, also has a clinical application as an

anti-anginal agent, in normotensive patients.

Please forgive me if I have misinterpreted what I have read, but I thought

the term " registration trials " would do it.

Best of luck

Coilín.

>-- I wonder if the concept of " études

>d'enregistrement " includes the very earliest studies done or if it, too,

>is limited to the studies in humans? François?)

>

>Still wondering but moving on or I won't meet my deadline,

>Marla

>

>

>--

>Marla J.F. O'Neill, M.D.

>Medical Translation & Editing

>French/Spanish/Italian>English

>mailto:mjfoneill@...

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

[Guest guest]

At 05/18/2001 11:26 AM, Coilín wrote:

>Have you excluded " registration trials " ?

Well, yeah, pretty much, since it appears to me

that " registration study/trial " implies " nonrandomized " .

If you read the description of the " registration study " at

the URL you sent

http://www.secinfo.com/dRE54.8hw.htm

you will see that the " registration " study carried out in Mexico

in 1996 was not randomized, the patients all received the drug.

A " Phase II clinical trial " conducted in Germany that same year,

however, *was* randomized and they specify that in their description.

(Your other URLs didn't specify one way or another.)

The most pertinent discussion that I have been able to find is

the following abstract:

AU - Riley D; Houghton J; Bates T

TI - Is there a place for nonrandomized, registration studies? (Meeting

abstract).

SO - Br J Cancer 1994;70(Suppl 22):23

AD - CRC Clinical Trials Centre, UK

Despite the randomized controlled clinical trial being the most scientific

way to assess treatment benefits, less than 8% of eligible patients are

entered into most trials of solid tumors. Is there a place for studies

evaluating treatment regimens without the randomization procedure, ie,

prospective cohort studies? The CRC Elderly Trial randomized 454 patients

receiving tamoxifen, into a trial evaluating the role of surgery in elderly

patients presenting with operable breast cancer. Many potentially eligible

patients were omitted and a parallel **registration study** was begun. As

in the randomized trial, patients received either tamoxifen alone (TAM) or

tamoxifen plus surgery (T+S), but the decision as to which treatment the

patient received was based on either patient choice or clinician

recommendation.

<snip>

For the randomized trial the two groups were well matched for known

prognostic variables. The two treatment groups in the **registration

study**, however, were not well matched. Those patients who received

immediate surgery were younger (median age = 73 years) and had clinically

smaller tumors (median size = 2.0 cm), than the tamoxifen alone group

(median age = 77.5 years, median tumor size = 3.0 cm). It is not surprising

therefore that the T+S group had a better long-term outcome than the

tamoxifen alone group. These data highlight the problems with nonrandomized

studies.

<end abstract>

This author, at least, explicity equates the term " registration study " with

a nonrandomized " prospective cohort study " .

I also found

http://cancer.med.upenn.edu/journals/journal-scan84.html

This is a prospective nonrandomized registration trial as a collaborative

effort of the National Thyroid Cancer Treatment ative Study Registry

from 14 institutions.

<snip>

This prospective multi-institutional registration trial is just a thorough

retrospective review. This in actuality is not much more powerful a study

than a retrospective review. There was no randomization and treatment was

not standardized. This becomes an issue when one tries to make conclusions

on what should be standard of care in the treatment of thyroid cancer.

<snip>

A prospective RANDOMIZED trial needs to be performed in order to fully

evaluate the benefit of each modality, especially EBRT.

<end>

And I found another breast cancer " registration study "

http://www.emory.edu/WHSC/WCI/research/clinical%20trials/breast/E5194.htm

" The Eastern ative Oncology Group is currently running a

**registration study** (ECOG E5194) looking at local excision alone for

selected patients with DCIS of the breast. Patients must have DCIS, low to

intermediate grade, less that or equal to 2.5 cm in greatest dimension or

high grade, less than or equal to 1.0 cm in greatest dimension (as measured

pathologically). "

in which the intent appears to be to simply follow the patients

after they are registered, with no randomization in the works.

HOWEVER, even as I was writing this email I was still searching,

and at

http://www.moffitt.usf.edu/pubs/ccj/v5ns/article6.html

I have found the following:

Registration Trial for Epoietin Alfa

In the original **registration trial** investigating recombinant EPO in

cancer chemotherapy-related anemia, patients were **randomized** to receive

either placebo or epoietin alfa.

<end>

and there are multiple references in that same article from Duke U. to

" registration trials " :

In the** US registration trial** of G-CSF (filgrastim), patients with

small-cell lung cancer received either placebo or G-CSF. G-CSF patients

received cyclophosphamide, doxorubicin, and etoposide in relatively high

doses, followed by either G-CSF support or placebo.

<end>

AUUUGH!

Now I'm wondering if there is a difference between " registration trial " (=

randomized clinical trial for drug approval purposes) and a " registration

study " (= nonrandomized prospective cohort study), although the

nonrandomized thyroid study above was called a " registration trial " ...

So there's where I stand right now --

feet firmly planted in the shifting sands...

Marla

--

Marla J.F. O'Neill, M.D.

Medical Translation & Editing

French/Spanish/Italian>English

mailto:mjfoneill@...

[Guest guest]

At 05/18/2001 11:26 AM, Coilín wrote:

>Have you excluded " registration trials " ?

Well, yeah, pretty much, since it appears to me

that " registration study/trial " implies " nonrandomized " .

If you read the description of the " registration study " at

the URL you sent

http://www.secinfo.com/dRE54.8hw.htm

you will see that the " registration " study carried out in Mexico

in 1996 was not randomized, the patients all received the drug.

A " Phase II clinical trial " conducted in Germany that same year,

however, *was* randomized and they specify that in their description.

(Your other URLs didn't specify one way or another.)

The most pertinent discussion that I have been able to find is

the following abstract:

AU - Riley D; Houghton J; Bates T

TI - Is there a place for nonrandomized, registration studies? (Meeting

abstract).

SO - Br J Cancer 1994;70(Suppl 22):23

AD - CRC Clinical Trials Centre, UK

Despite the randomized controlled clinical trial being the most scientific

way to assess treatment benefits, less than 8% of eligible patients are

entered into most trials of solid tumors. Is there a place for studies

evaluating treatment regimens without the randomization procedure, ie,

prospective cohort studies? The CRC Elderly Trial randomized 454 patients

receiving tamoxifen, into a trial evaluating the role of surgery in elderly

patients presenting with operable breast cancer. Many potentially eligible

patients were omitted and a parallel **registration study** was begun. As

in the randomized trial, patients received either tamoxifen alone (TAM) or

tamoxifen plus surgery (T+S), but the decision as to which treatment the

patient received was based on either patient choice or clinician

recommendation.

<snip>

For the randomized trial the two groups were well matched for known

prognostic variables. The two treatment groups in the **registration

study**, however, were not well matched. Those patients who received

immediate surgery were younger (median age = 73 years) and had clinically

smaller tumors (median size = 2.0 cm), than the tamoxifen alone group

(median age = 77.5 years, median tumor size = 3.0 cm). It is not surprising

therefore that the T+S group had a better long-term outcome than the

tamoxifen alone group. These data highlight the problems with nonrandomized

studies.

<end abstract>

This author, at least, explicity equates the term " registration study " with

a nonrandomized " prospective cohort study " .

I also found

http://cancer.med.upenn.edu/journals/journal-scan84.html

This is a prospective nonrandomized registration trial as a collaborative

effort of the National Thyroid Cancer Treatment ative Study Registry

from 14 institutions.

<snip>

This prospective multi-institutional registration trial is just a thorough

retrospective review. This in actuality is not much more powerful a study

than a retrospective review. There was no randomization and treatment was

not standardized. This becomes an issue when one tries to make conclusions

on what should be standard of care in the treatment of thyroid cancer.

<snip>

A prospective RANDOMIZED trial needs to be performed in order to fully

evaluate the benefit of each modality, especially EBRT.

<end>

And I found another breast cancer " registration study "

http://www.emory.edu/WHSC/WCI/research/clinical%20trials/breast/E5194.htm

" The Eastern ative Oncology Group is currently running a

**registration study** (ECOG E5194) looking at local excision alone for

selected patients with DCIS of the breast. Patients must have DCIS, low to

intermediate grade, less that or equal to 2.5 cm in greatest dimension or

high grade, less than or equal to 1.0 cm in greatest dimension (as measured

pathologically). "

in which the intent appears to be to simply follow the patients

after they are registered, with no randomization in the works.

HOWEVER, even as I was writing this email I was still searching,

and at

http://www.moffitt.usf.edu/pubs/ccj/v5ns/article6.html

I have found the following:

Registration Trial for Epoietin Alfa

In the original **registration trial** investigating recombinant EPO in

cancer chemotherapy-related anemia, patients were **randomized** to receive

either placebo or epoietin alfa.

<end>

and there are multiple references in that same article from Duke U. to

" registration trials " :

In the** US registration trial** of G-CSF (filgrastim), patients with

small-cell lung cancer received either placebo or G-CSF. G-CSF patients

received cyclophosphamide, doxorubicin, and etoposide in relatively high

doses, followed by either G-CSF support or placebo.

<end>

AUUUGH!

Now I'm wondering if there is a difference between " registration trial " (=

randomized clinical trial for drug approval purposes) and a " registration

study " (= nonrandomized prospective cohort study), although the

nonrandomized thyroid study above was called a " registration trial " ...

So there's where I stand right now --

feet firmly planted in the shifting sands...

Marla

--

Marla J.F. O'Neill, M.D.

Medical Translation & Editing

French/Spanish/Italian>English

mailto:mjfoneill@...

[Guest guest]

Marla, If the term occurs frequently, you can certainly use " clinical

trials " a few times. However, there are clinical trials that have nothing to

do with drug registration (tests of protocols, etc.), and there are drug

registration studies that have nothing to do with clinical trials (phase I

studies in experimental animals).

Barbara

etude d'enregistrement = clinical trial?

> Thanks for your comments, Coilín, Barbara and François.

>

> I'm still looking, but it appears that I was led astray by a false

> cognate -- i.e., there *is* such thing as " registration studies " in

> English, but I've come to realize that it doesn't mean the same

> thing as " études d'enregistrement " in French.

>

> As per François and other French sources, " études d'enregistrement "

> are basically what Barbara suggested, " studies to support drug

> registration " . However, that phrase is kind of long for my context --

> I wonder if I could just use " clinical trials " , or is that too specific?

> ( " Clinical trials " only refers to trials in humans AFAIK, and there

> are of course earlier studies done in animals which are " in support of "

> the drug registration process -- I wonder if the concept of " études

> d'enregistrement " includes the very earliest studies done or if it, too,

> is limited to the studies in humans? François?)

>

> Still wondering but moving on or I won't meet my deadline,

> Marla

>

>

> --

> Marla J.F. O'Neill, M.D.

> Medical Translation & Editing

> French/Spanish/Italian>English

> mailto:mjfoneill@...

>

>

> URL: http://groups.yahoo.com/group/medical_translation

>

> To unsubscribe, please send an *empty* message to

> medical_translation-UNSUBSCRIBE

>

>

[Guest guest]

Marla,

I don't think that the condition of randomization/nonrandomization is

inherent to any clinical trial, although " randomization " is considered

desireable. In the instances you've given, it seems to me that

" randomization " is just one of the characteristics of the trial, not a

condition.

Barbara

Re: etude d'enregistrement = clinical trial?

> At 05/18/2001 11:26 AM, Coilín wrote:

> >Have you excluded " registration trials " ?

>

> Well, yeah, pretty much, since it appears to me

> that " registration study/trial " implies " nonrandomized " .

>

> If you read the description of the " registration study " at

> the URL you sent

> http://www.secinfo.com/dRE54.8hw.htm

> you will see that the " registration " study carried out in Mexico

> in 1996 was not randomized, the patients all received the drug.

> A " Phase II clinical trial " conducted in Germany that same year,

> however, *was* randomized and they specify that in their description.

> (Your other URLs didn't specify one way or another.)

>

> The most pertinent discussion that I have been able to find is

> the following abstract:

> AU - Riley D; Houghton J; Bates T

> TI - Is there a place for nonrandomized, registration studies? (Meeting

> abstract).

> SO - Br J Cancer 1994;70(Suppl 22):23

> AD - CRC Clinical Trials Centre, UK

> Despite the randomized controlled clinical trial being the most scientific

> way to assess treatment benefits, less than 8% of eligible patients are

> entered into most trials of solid tumors. Is there a place for studies

> evaluating treatment regimens without the randomization procedure, ie,

> prospective cohort studies? The CRC Elderly Trial randomized 454 patients

> receiving tamoxifen, into a trial evaluating the role of surgery in

elderly

> patients presenting with operable breast cancer. Many potentially eligible

> patients were omitted and a parallel **registration study** was begun. As

> in the randomized trial, patients received either tamoxifen alone (TAM) or

> tamoxifen plus surgery (T+S), but the decision as to which treatment the

> patient received was based on either patient choice or clinician

> recommendation.

> <snip>

> For the randomized trial the two groups were well matched for known

> prognostic variables. The two treatment groups in the **registration

> study**, however, were not well matched. Those patients who received

> immediate surgery were younger (median age = 73 years) and had clinically

> smaller tumors (median size = 2.0 cm), than the tamoxifen alone group

> (median age = 77.5 years, median tumor size = 3.0 cm). It is not

surprising

> therefore that the T+S group had a better long-term outcome than the

> tamoxifen alone group. These data highlight the problems with

nonrandomized

> studies.

> <end abstract>

>

> This author, at least, explicity equates the term " registration study "

with

> a nonrandomized " prospective cohort study " .

>

> I also found

> http://cancer.med.upenn.edu/journals/journal-scan84.html

> This is a prospective nonrandomized registration trial as a collaborative

> effort of the National Thyroid Cancer Treatment ative Study Registry

> from 14 institutions.

> <snip>

> This prospective multi-institutional registration trial is just a thorough

> retrospective review. This in actuality is not much more powerful a study

> than a retrospective review. There was no randomization and treatment was

> not standardized. This becomes an issue when one tries to make conclusions

> on what should be standard of care in the treatment of thyroid cancer.

> <snip>

> A prospective RANDOMIZED trial needs to be performed in order to fully

> evaluate the benefit of each modality, especially EBRT.

> <end>

>

> And I found another breast cancer " registration study "

> http://www.emory.edu/WHSC/WCI/research/clinical%20trials/breast/E5194.htm

> " The Eastern ative Oncology Group is currently running a

> **registration study** (ECOG E5194) looking at local excision alone for

> selected patients with DCIS of the breast. Patients must have DCIS, low to

> intermediate grade, less that or equal to 2.5 cm in greatest dimension or

> high grade, less than or equal to 1.0 cm in greatest dimension (as

measured

> pathologically). "

> in which the intent appears to be to simply follow the patients

> after they are registered, with no randomization in the works.

>

> HOWEVER, even as I was writing this email I was still searching,

> and at

> http://www.moffitt.usf.edu/pubs/ccj/v5ns/article6.html

> I have found the following:

> Registration Trial for Epoietin Alfa

> In the original **registration trial** investigating recombinant EPO in

> cancer chemotherapy-related anemia, patients were **randomized** to

receive

> either placebo or epoietin alfa.

> <end>

> and there are multiple references in that same article from Duke U. to

> " registration trials " :

> In the** US registration trial** of G-CSF (filgrastim), patients with

> small-cell lung cancer received either placebo or G-CSF. G-CSF patients

> received cyclophosphamide, doxorubicin, and etoposide in relatively high

> doses, followed by either G-CSF support or placebo.

> <end>

>

> AUUUGH!

> Now I'm wondering if there is a difference between " registration trial " (=

> randomized clinical trial for drug approval purposes) and a " registration

> study " (= nonrandomized prospective cohort study), although the

> nonrandomized thyroid study above was called a " registration trial " ...

>

> So there's where I stand right now --

> feet firmly planted in the shifting sands...

> Marla

> --

> Marla J.F. O'Neill, M.D.

> Medical Translation & Editing

> French/Spanish/Italian>English

> mailto:mjfoneill@...

>

>

[Guest guest]

Marla,

I don't think that the condition of randomization/nonrandomization is

inherent to any clinical trial, although " randomization " is considered

desireable. In the instances you've given, it seems to me that

" randomization " is just one of the characteristics of the trial, not a

condition.

Barbara

Re: etude d'enregistrement = clinical trial?

> At 05/18/2001 11:26 AM, Coilín wrote:

> >Have you excluded " registration trials " ?

>

> Well, yeah, pretty much, since it appears to me

> that " registration study/trial " implies " nonrandomized " .

>

> If you read the description of the " registration study " at

> the URL you sent

> http://www.secinfo.com/dRE54.8hw.htm

> you will see that the " registration " study carried out in Mexico

> in 1996 was not randomized, the patients all received the drug.

> A " Phase II clinical trial " conducted in Germany that same year,

> however, *was* randomized and they specify that in their description.

> (Your other URLs didn't specify one way or another.)

>

> The most pertinent discussion that I have been able to find is

> the following abstract:

> AU - Riley D; Houghton J; Bates T

> TI - Is there a place for nonrandomized, registration studies? (Meeting

> abstract).

> SO - Br J Cancer 1994;70(Suppl 22):23

> AD - CRC Clinical Trials Centre, UK

> Despite the randomized controlled clinical trial being the most scientific

> way to assess treatment benefits, less than 8% of eligible patients are

> entered into most trials of solid tumors. Is there a place for studies

> evaluating treatment regimens without the randomization procedure, ie,

> prospective cohort studies? The CRC Elderly Trial randomized 454 patients

> receiving tamoxifen, into a trial evaluating the role of surgery in

elderly

> patients presenting with operable breast cancer. Many potentially eligible

> patients were omitted and a parallel **registration study** was begun. As

> in the randomized trial, patients received either tamoxifen alone (TAM) or

> tamoxifen plus surgery (T+S), but the decision as to which treatment the

> patient received was based on either patient choice or clinician

> recommendation.

> <snip>

> For the randomized trial the two groups were well matched for known

> prognostic variables. The two treatment groups in the **registration

> study**, however, were not well matched. Those patients who received

> immediate surgery were younger (median age = 73 years) and had clinically

> smaller tumors (median size = 2.0 cm), than the tamoxifen alone group

> (median age = 77.5 years, median tumor size = 3.0 cm). It is not

surprising

> therefore that the T+S group had a better long-term outcome than the

> tamoxifen alone group. These data highlight the problems with

nonrandomized

> studies.

> <end abstract>

>

> This author, at least, explicity equates the term " registration study "

with

> a nonrandomized " prospective cohort study " .

>

> I also found

> http://cancer.med.upenn.edu/journals/journal-scan84.html

> This is a prospective nonrandomized registration trial as a collaborative

> effort of the National Thyroid Cancer Treatment ative Study Registry

> from 14 institutions.

> <snip>

> This prospective multi-institutional registration trial is just a thorough

> retrospective review. This in actuality is not much more powerful a study

> than a retrospective review. There was no randomization and treatment was

> not standardized. This becomes an issue when one tries to make conclusions

> on what should be standard of care in the treatment of thyroid cancer.

> <snip>

> A prospective RANDOMIZED trial needs to be performed in order to fully

> evaluate the benefit of each modality, especially EBRT.

> <end>

>

> And I found another breast cancer " registration study "

> http://www.emory.edu/WHSC/WCI/research/clinical%20trials/breast/E5194.htm

> " The Eastern ative Oncology Group is currently running a

> **registration study** (ECOG E5194) looking at local excision alone for

> selected patients with DCIS of the breast. Patients must have DCIS, low to

> intermediate grade, less that or equal to 2.5 cm in greatest dimension or

> high grade, less than or equal to 1.0 cm in greatest dimension (as

measured

> pathologically). "

> in which the intent appears to be to simply follow the patients

> after they are registered, with no randomization in the works.

>

> HOWEVER, even as I was writing this email I was still searching,

> and at

> http://www.moffitt.usf.edu/pubs/ccj/v5ns/article6.html

> I have found the following:

> Registration Trial for Epoietin Alfa

> In the original **registration trial** investigating recombinant EPO in

> cancer chemotherapy-related anemia, patients were **randomized** to

receive

> either placebo or epoietin alfa.

> <end>

> and there are multiple references in that same article from Duke U. to

> " registration trials " :

> In the** US registration trial** of G-CSF (filgrastim), patients with

> small-cell lung cancer received either placebo or G-CSF. G-CSF patients

> received cyclophosphamide, doxorubicin, and etoposide in relatively high

> doses, followed by either G-CSF support or placebo.

> <end>

>

> AUUUGH!

> Now I'm wondering if there is a difference between " registration trial " (=

> randomized clinical trial for drug approval purposes) and a " registration

> study " (= nonrandomized prospective cohort study), although the

> nonrandomized thyroid study above was called a " registration trial " ...

>

> So there's where I stand right now --

> feet firmly planted in the shifting sands...

> Marla

> --

> Marla J.F. O'Neill, M.D.

> Medical Translation & Editing

> French/Spanish/Italian>English

> mailto:mjfoneill@...

>

>

[Guest guest]

Very confusing, Marla. My deepest sympathies, as I have also found your

examples fairly perplexing.

I suspect that we are, as you suggest, dealing with a difference between

the terms, " registration study " and " registration trial " . And/or with two

distinct meanings for the term " registration trial " .

The registration studies you mention may be named for their relation to

**cancer registration**. The whole process of cancer registration, as you

probably know, is designed to facilitate prospective cohort studies to see

how patients with different kinds of cancer get on, both in general and

under different circumstances. The second URL you mention seems to refer to

the same kind of study, here called a registration _trial_.

But, as far as I can see, the term " registration trial of [new drug X] "

seems almost invariably to refer to trials of efficacy and safety with a

view to registration of [new drug X] as being permitted for marketing for

the treatment of humans in a given country. Most of these will be

randomised, but apparently not all.

In summary, we are dealing with studies/trials related to two different

kind of registration. Then the paradoxes becomes comprehensible, no? In any

case, this is the best explanation I can come to. I hope this is correct

and relieves your very understandable state of puzzlement.

All the best

Coilín.

At 12:34 18-05-01 -0400, you wrote:

>At 05/18/2001 11:26 AM, Coilín wrote:

> >Have you excluded " registration trials " ?

>

>Well, yeah, pretty much, since it appears to me

>that " registration study/trial " implies " nonrandomized " .

>

>If you read the description of the " registration study " at

>the URL you sent

>http://www.secinfo.com/dRE54.8hw.htm

>you will see that the " registration " study carried out in Mexico

>in 1996 was not randomized, the patients all received the drug.

>A " Phase II clinical trial " conducted in Germany that same year,

>however, *was* randomized and they specify that in their description.

>(Your other URLs didn't specify one way or another.)

>

>The most pertinent discussion that I have been able to find is

>the following abstract:

>AU - Riley D; Houghton J; Bates T

>TI - Is there a place for nonrandomized, registration studies? (Meeting

>abstract).

>SO - Br J Cancer 1994;70(Suppl 22):23

>AD - CRC Clinical Trials Centre, UK

>Despite the randomized controlled clinical trial being the most scientific

>way to assess treatment benefits, less than 8% of eligible patients are

>entered into most trials of solid tumors. Is there a place for studies

>evaluating treatment regimens without the randomization procedure, ie,

>prospective cohort studies? The CRC Elderly Trial randomized 454 patients

>receiving tamoxifen, into a trial evaluating the role of surgery in elderly

>patients presenting with operable breast cancer. Many potentially eligible

>patients were omitted and a parallel **registration study** was begun. As

>in the randomized trial, patients received either tamoxifen alone (TAM) or

>tamoxifen plus surgery (T+S), but the decision as to which treatment the

>patient received was based on either patient choice or clinician

>recommendation.

><snip>

>For the randomized trial the two groups were well matched for known

>prognostic variables. The two treatment groups in the **registration

>study**, however, were not well matched. Those patients who received

>immediate surgery were younger (median age = 73 years) and had clinically

>smaller tumors (median size = 2.0 cm), than the tamoxifen alone group

>(median age = 77.5 years, median tumor size = 3.0 cm). It is not surprising

>therefore that the T+S group had a better long-term outcome than the

>tamoxifen alone group. These data highlight the problems with nonrandomized

>studies.

><end abstract>

>

>This author, at least, explicity equates the term " registration study " with

>a nonrandomized " prospective cohort study " .

>

>I also found

>http://cancer.med.upenn.edu/journals/journal-scan84.html

>This is a prospective nonrandomized registration trial as a collaborative

>effort of the National Thyroid Cancer Treatment ative Study Registry

>from 14 institutions.

><snip>

>This prospective multi-institutional registration trial is just a thorough

>retrospective review. This in actuality is not much more powerful a study

>than a retrospective review. There was no randomization and treatment was

>not standardized. This becomes an issue when one tries to make conclusions

>on what should be standard of care in the treatment of thyroid cancer.

><snip>

>A prospective RANDOMIZED trial needs to be performed in order to fully

>evaluate the benefit of each modality, especially EBRT.

><end>

>

>And I found another breast cancer " registration study "

>http://www.emory.edu/WHSC/WCI/research/clinical%20trials/breast/E5194.htm

> " The Eastern ative Oncology Group is currently running a

>**registration study** (ECOG E5194) looking at local excision alone for

>selected patients with DCIS of the breast. Patients must have DCIS, low to

>intermediate grade, less that or equal to 2.5 cm in greatest dimension or

>high grade, less than or equal to 1.0 cm in greatest dimension (as measured

>pathologically). "

>in which the intent appears to be to simply follow the patients

>after they are registered, with no randomization in the works.

>

>HOWEVER, even as I was writing this email I was still searching,

>and at

>http://www.moffitt.usf.edu/pubs/ccj/v5ns/article6.html

>I have found the following:

>Registration Trial for Epoietin Alfa

>In the original **registration trial** investigating recombinant EPO in

>cancer chemotherapy-related anemia, patients were **randomized** to receive

>either placebo or epoietin alfa.

><end>

>and there are multiple references in that same article from Duke U. to

> " registration trials " :

>In the** US registration trial** of G-CSF (filgrastim), patients with

>small-cell lung cancer received either placebo or G-CSF. G-CSF patients

>received cyclophosphamide, doxorubicin, and etoposide in relatively high

>doses, followed by either G-CSF support or placebo.

><end>

>

>AUUUGH!

>Now I'm wondering if there is a difference between " registration trial " (=

>randomized clinical trial for drug approval purposes) and a " registration

>study " (= nonrandomized prospective cohort study), although the

>nonrandomized thyroid study above was called a " registration trial " ...

>

>So there's where I stand right now --

>feet firmly planted in the shifting sands...

>Marla

>--

>Marla J.F. O'Neill, M.D.

>Medical Translation & Editing

>French/Spanish/Italian>English

>mailto:mjfoneill@...

>

>

[Guest guest]

At 05/18/2001 01:16 PM, Coilín wrote:

>Very confusing, Marla. My deepest sympathies, as I have also found your

>examples fairly perplexing.

>I suspect that we are, as you suggest, dealing with a difference between

>the terms, " registration study " and " registration trial " . And/or with two

>distinct meanings for the term " registration trial " .

><snip>

>In summary, we are dealing with studies/trials related to two different

>kind of registration.

This is my feeling as well. In my original context, I think " US

registration trials " (meaning clinical trials for drug approval purposes)

is appropriate.

The phrase only occurred once in my article, Barbara, so I think that I

could have used " clinical trials " as you suggested without any real loss of

meaning. In answer to your other comment regarding " randomization " , I would

agree with you in that clinical trials may or may not be randomized; but my

point was that some of these authors seemed to be using the word

" registration " to mean a study that was not randomized (i.e, the patients

are simply registered and followed to see what happens to them).

Thanks very much to both Barbara and Coilín for following

my progress on this and steering me in the right direction!

Marla

--

Marla J.F. O'Neill, M.D.

Medical Translation & Editing

French/Spanish/Italian>English

mailto:mjfoneill@...

[Guest guest]

At 13:42 18-05-01 -0400, you wrote:

>At 05/18/2001 01:16 PM, Coilín wrote:

> >Very confusing, Marla. My deepest sympathies, as I have also found your

> >examples fairly perplexing.

> >I suspect that we are, as you suggest, dealing with a difference between

> >the terms, " registration study " and " registration trial " . And/or with two

> >distinct meanings for the term " registration trial " .

> ><snip>

> >In summary, we are dealing with studies/trials related to two different

> >kind of registration.

>

>This is my feeling as well. In my original context, I think " US

>registration trials " (meaning clinical trials for drug approval purposes)

>is appropriate.

Sounds good.

>The phrase only occurred once in my article, Barbara, so I think that I

>could have used " clinical trials " as you suggested without any real loss of

>meaning. In answer to your other comment regarding " randomization " , I would

>agree with you in that clinical trials may or may not be randomized; but my

>point was that some of these authors seemed to be using the word

> " registration " to mean a study that was not randomized (i.e, the patients

>are simply registered and followed to see what happens to them).

Yes, that implication was there - but as far as I remember exclusively in

connection with the cancer registration studies - prospective cohort

studies, which are typically non-randomised. No?

>Thanks very much to both Barbara and Coilín for following

>my progress on this and steering me in the right direction!

A pleasure! I learnt something interesting from this.

See you later

Coilín.

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

[Guest guest]

At 13:42 18-05-01 -0400, you wrote:

>At 05/18/2001 01:16 PM, Coilín wrote:

> >Very confusing, Marla. My deepest sympathies, as I have also found your

> >examples fairly perplexing.

> >I suspect that we are, as you suggest, dealing with a difference between

> >the terms, " registration study " and " registration trial " . And/or with two

> >distinct meanings for the term " registration trial " .

> ><snip>

> >In summary, we are dealing with studies/trials related to two different

> >kind of registration.

>

>This is my feeling as well. In my original context, I think " US

>registration trials " (meaning clinical trials for drug approval purposes)

>is appropriate.

Sounds good.

>The phrase only occurred once in my article, Barbara, so I think that I

>could have used " clinical trials " as you suggested without any real loss of

>meaning. In answer to your other comment regarding " randomization " , I would

>agree with you in that clinical trials may or may not be randomized; but my

>point was that some of these authors seemed to be using the word

> " registration " to mean a study that was not randomized (i.e, the patients

>are simply registered and followed to see what happens to them).

Yes, that implication was there - but as far as I remember exclusively in

connection with the cancer registration studies - prospective cohort

studies, which are typically non-randomised. No?

>Thanks very much to both Barbara and Coilín for following

>my progress on this and steering me in the right direction!

A pleasure! I learnt something interesting from this.

See you later

Coilín.

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

[Guest guest]

Barbara :

>I don't think that the condition of randomization/nonrandomization is

>inherent to any clinical trial, although " randomization " is considered

>desireable. In the instances you've given, it seems to me that

> " randomization " is just one of the characteristics of the trial, not a

>condition.

That is correct. Some trials are non-randomised for ethical reasons.

--

Maarten de Bruijn PhD, AITI matmed@...

19 Belmont Avenue Tel: 0044 1625 422797

Macclesfield Medical/pharmaceutical/financial

Cheshire SK10 3JN, UK Dutch<>English

[Guest guest]

Barbara :

>I don't think that the condition of randomization/nonrandomization is

>inherent to any clinical trial, although " randomization " is considered

>desireable. In the instances you've given, it seems to me that

> " randomization " is just one of the characteristics of the trial, not a

>condition.

That is correct. Some trials are non-randomised for ethical reasons.

--

Maarten de Bruijn PhD, AITI matmed@...

19 Belmont Avenue Tel: 0044 1625 422797

Macclesfield Medical/pharmaceutical/financial

Cheshire SK10 3JN, UK Dutch<>English

[Guest guest]

Barbara :

>(phase I

>studies in experimental animals)

I don't think these are Phase I. Phase I is in human volunteers/healthy

subjects or whatever other human baseline that is appropriate. It is a

human safety/tolerability study. Animal studies are done before that

(potential efficacy, safety, etc)

--

Maarten de Bruijn PhD, AITI matmed@...

19 Belmont Avenue Tel: 0044 1625 422797

Macclesfield Medical/pharmaceutical/financial

Cheshire SK10 3JN, UK Dutch<>English

[Guest guest]

Barbara :

>(phase I

>studies in experimental animals)

I don't think these are Phase I. Phase I is in human volunteers/healthy

subjects or whatever other human baseline that is appropriate. It is a

human safety/tolerability study. Animal studies are done before that

(potential efficacy, safety, etc)

--

Maarten de Bruijn PhD, AITI matmed@...

19 Belmont Avenue Tel: 0044 1625 422797

Macclesfield Medical/pharmaceutical/financial

Cheshire SK10 3JN, UK Dutch<>English

[Guest guest]

At 05/18/2001 01:51 PM, Coilín wrote:

> >In answer to your other comment regarding " randomization " , I would

> >agree with you in that clinical trials may or may not be randomized; but my

> >point was that some of these authors seemed to be using the word

> > " registration " to mean a study that was not randomized (i.e, the patients

> >are simply registered and followed to see what happens to them).

>

>Yes, that implication was there - but as far as I remember exclusively in

>connection with the cancer registration studies - prospective cohort

>studies, which are typically non-randomised. No?

No, there was also the study from your URL

http://www.secinfo.com/dRE54.8hw.htm

which was for a viagra-like drug which used the

" registration " terminology for a study in which

the men were (apparently) simply given the drug

and then monitored for side effects (and presumably

for effectiveness of the drug as well!).

Marla

--

Marla J.F. O'Neill, M.D.

Medical Translation & Editing

French/Spanish/Italian>English

mailto:mjfoneill@...

[Guest guest]

At 05/18/2001 01:51 PM, Coilín wrote:

> >In answer to your other comment regarding " randomization " , I would

> >agree with you in that clinical trials may or may not be randomized; but my

> >point was that some of these authors seemed to be using the word

> > " registration " to mean a study that was not randomized (i.e, the patients

> >are simply registered and followed to see what happens to them).

>

>Yes, that implication was there - but as far as I remember exclusively in

>connection with the cancer registration studies - prospective cohort

>studies, which are typically non-randomised. No?

No, there was also the study from your URL

http://www.secinfo.com/dRE54.8hw.htm

which was for a viagra-like drug which used the

" registration " terminology for a study in which

the men were (apparently) simply given the drug

and then monitored for side effects (and presumably

for effectiveness of the drug as well!).

Marla

--

Marla J.F. O'Neill, M.D.

Medical Translation & Editing

French/Spanish/Italian>English

mailto:mjfoneill@...

[Guest guest]

And while we are on this terminological beach ( obviously not a quicksand as

our protagonists seem to be keeping their heads above water very

efficiently) could some one clear up something that I have worried about for

a while - étude ou essai, study or trial, how synonymous are they and would

it ever be a gross error to say one for the other?

This is absolutely non-urgent and as it is Friday night here in Europe we

should all be relaxing....!

Anne Claydon-Wallace

Re: etude d'enregistrement = clinical trial?

At 13:42 18-05-01 -0400, you wrote:

>At 05/18/2001 01:16 PM, Coilín wrote:

> >Very confusing, Marla. My deepest sympathies, as I have also found your

> >examples fairly perplexing.

> >I suspect that we are, as you suggest, dealing with a difference between

> >the terms, " registration study " and " registration trial " . And/or with two

> >distinct meanings for the term " registration trial " .

> ><snip>

> >In summary, we are dealing with studies/trials related to two different

> >kind of registration.

>

>This is my feeling as well. In my original context, I think " US

>registration trials " (meaning clinical trials for drug approval purposes)

>is appropriate.

Sounds good.

>The phrase only occurred once in my article, Barbara, so I think that I

>could have used " clinical trials " as you suggested without any real loss of

>meaning. In answer to your other comment regarding " randomization " , I would

>agree with you in that clinical trials may or may not be randomized; but my

>point was that some of these authors seemed to be using the word

> " registration " to mean a study that was not randomized (i.e, the patients

>are simply registered and followed to see what happens to them).

Yes, that implication was there - but as far as I remember exclusively in

connection with the cancer registration studies - prospective cohort

studies, which are typically non-randomised. No?

>Thanks very much to both Barbara and Coilín for following

>my progress on this and steering me in the right direction!

A pleasure! I learnt something interesting from this.

See you later

Coilín.

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

URL: http://groups.yahoo.com/group/medical_translation

To unsubscribe, please send an *empty* message to

medical_translation-UNSUBSCRIBE

[Guest guest]

And while we are on this terminological beach ( obviously not a quicksand as

our protagonists seem to be keeping their heads above water very

efficiently) could some one clear up something that I have worried about for

a while - étude ou essai, study or trial, how synonymous are they and would

it ever be a gross error to say one for the other?

This is absolutely non-urgent and as it is Friday night here in Europe we

should all be relaxing....!

Anne Claydon-Wallace

Re: etude d'enregistrement = clinical trial?

At 13:42 18-05-01 -0400, you wrote:

>At 05/18/2001 01:16 PM, Coilín wrote:

> >Very confusing, Marla. My deepest sympathies, as I have also found your

> >examples fairly perplexing.

> >I suspect that we are, as you suggest, dealing with a difference between

> >the terms, " registration study " and " registration trial " . And/or with two

> >distinct meanings for the term " registration trial " .

> ><snip>

> >In summary, we are dealing with studies/trials related to two different

> >kind of registration.

>

>This is my feeling as well. In my original context, I think " US

>registration trials " (meaning clinical trials for drug approval purposes)

>is appropriate.

Sounds good.

>The phrase only occurred once in my article, Barbara, so I think that I

>could have used " clinical trials " as you suggested without any real loss of

>meaning. In answer to your other comment regarding " randomization " , I would

>agree with you in that clinical trials may or may not be randomized; but my

>point was that some of these authors seemed to be using the word

> " registration " to mean a study that was not randomized (i.e, the patients

>are simply registered and followed to see what happens to them).

Yes, that implication was there - but as far as I remember exclusively in

connection with the cancer registration studies - prospective cohort

studies, which are typically non-randomised. No?

>Thanks very much to both Barbara and Coilín for following

>my progress on this and steering me in the right direction!

A pleasure! I learnt something interesting from this.

See you later

Coilín.

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

URL: http://groups.yahoo.com/group/medical_translation

To unsubscribe, please send an *empty* message to

medical_translation-UNSUBSCRIBE

[Guest guest]

At 19:56 18-05-01 +0100, Anne wrote:

>And while we are on this terminological beach ( obviously not a quicksand as

>our protagonists seem to be keeping their heads above water very

>efficiently) could some one clear up something that I have worried about for

>a while - étude ou essai, study or trial, how synonymous are they and would

>it ever be a gross error to say one for the other?

>This is absolutely non-urgent and as it is Friday night here in Europe we

>should all be relaxing....!

Well, I've been out to see some smiling faces and come back in now, so I am

prepared to give a relaxed reply to this. I think Friday evening is a

perfect time to discuss such a non-urgent topic.

Without much thought at all, I can think of studies that ought not to be

called trials. Descriptive studies - e.g. a prospective cohort study of the

life expectancy of people with breast cancer - cannot be described as

trials, I don't think.

Nor do I think a retrospective study can be called a trial, even if we are

comparing two groups of patients, of which one was treated with tamoxifen

and another received no treatment. I think a trial is essentially

prospective and involves the study of a particular therapeutic measure,

e.g. prescription of drug " Fabulanova " .

I think it is fair to say that every trial is a study, but many studies are

not trials.

My training makes me doubt and question everything I say, but I think these

statements hold. Anybody care to correct or contradict me on any point?

Best regards

Coilín.

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

[Guest guest]

At 19:56 18-05-01 +0100, Anne wrote:

>And while we are on this terminological beach ( obviously not a quicksand as

>our protagonists seem to be keeping their heads above water very

>efficiently) could some one clear up something that I have worried about for

>a while - étude ou essai, study or trial, how synonymous are they and would

>it ever be a gross error to say one for the other?

>This is absolutely non-urgent and as it is Friday night here in Europe we

>should all be relaxing....!

Well, I've been out to see some smiling faces and come back in now, so I am

prepared to give a relaxed reply to this. I think Friday evening is a

perfect time to discuss such a non-urgent topic.

Without much thought at all, I can think of studies that ought not to be

called trials. Descriptive studies - e.g. a prospective cohort study of the

life expectancy of people with breast cancer - cannot be described as

trials, I don't think.

Nor do I think a retrospective study can be called a trial, even if we are

comparing two groups of patients, of which one was treated with tamoxifen

and another received no treatment. I think a trial is essentially

prospective and involves the study of a particular therapeutic measure,

e.g. prescription of drug " Fabulanova " .

I think it is fair to say that every trial is a study, but many studies are

not trials.

My training makes me doubt and question everything I say, but I think these

statements hold. Anybody care to correct or contradict me on any point?

Best regards

Coilín.

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

[Guest guest]

Thanks Coilin

Sounds reasonable. This is one of those questions you always want to ask

but never do, partly out of fear of becoming the translators' equivalent of

the man in a Bateman cartoon! By the way what does 'Fabulanova' do and is

it available ovathacounta?

All the best

Owen

10:52 PM 5/18/01 +0200, you wrote:

>At 19:56 18-05-01 +0100, Anne wrote:

>>And while we are on this terminological beach ( obviously not a quicksand as

>>our protagonists seem to be keeping their heads above water very

>>efficiently) could some one clear up something that I have worried about for

>>a while - étude ou essai, study or trial, how synonymous are they and would

>>it ever be a gross error to say one for the other?

>>This is absolutely non-urgent and as it is Friday night here in Europe we

>>should all be relaxing....!

>

>Well, I've been out to see some smiling faces and come back in now, so I am

>prepared to give a relaxed reply to this. I think Friday evening is a

>perfect time to discuss such a non-urgent topic.

>

>Without much thought at all, I can think of studies that ought not to be

>called trials. Descriptive studies - e.g. a prospective cohort study of the

>life expectancy of people with breast cancer - cannot be described as

>trials, I don't think.

>

>Nor do I think a retrospective study can be called a trial, even if we are

>comparing two groups of patients, of which one was treated with tamoxifen

>and another received no treatment. I think a trial is essentially

>prospective and involves the study of a particular therapeutic measure,

>e.g. prescription of drug " Fabulanova " .

>

>I think it is fair to say that every trial is a study, but many studies are

>not trials.

>

>My training makes me doubt and question everything I say, but I think these

>statements hold. Anybody care to correct or contradict me on any point?

>

>Best regards

>Coilín.

>

>

>Coilín ÓhAiseadha. da>en no>en translator

>Aa-Tchoo! Entertainments Translations: www.aatchoo.com

>Tsentsak Medical Translations: tsentsak@...

>+45 3616 5666 / 2192 5666

>

>

>URL: http://groups.yahoo.com/group/medical_translation

>

>To unsubscribe, please send an *empty* message to

>medical_translation-UNSUBSCRIBE

>

>

[Guest guest]

Thanks Coilin

Sounds reasonable. This is one of those questions you always want to ask

but never do, partly out of fear of becoming the translators' equivalent of

the man in a Bateman cartoon! By the way what does 'Fabulanova' do and is

it available ovathacounta?

All the best

Owen

10:52 PM 5/18/01 +0200, you wrote:

>At 19:56 18-05-01 +0100, Anne wrote:

>>And while we are on this terminological beach ( obviously not a quicksand as

>>our protagonists seem to be keeping their heads above water very

>>efficiently) could some one clear up something that I have worried about for

>>a while - étude ou essai, study or trial, how synonymous are they and would

>>it ever be a gross error to say one for the other?

>>This is absolutely non-urgent and as it is Friday night here in Europe we

>>should all be relaxing....!

>

>Well, I've been out to see some smiling faces and come back in now, so I am

>prepared to give a relaxed reply to this. I think Friday evening is a

>perfect time to discuss such a non-urgent topic.

>

>Without much thought at all, I can think of studies that ought not to be

>called trials. Descriptive studies - e.g. a prospective cohort study of the

>life expectancy of people with breast cancer - cannot be described as

>trials, I don't think.

>

>Nor do I think a retrospective study can be called a trial, even if we are

>comparing two groups of patients, of which one was treated with tamoxifen

>and another received no treatment. I think a trial is essentially

>prospective and involves the study of a particular therapeutic measure,

>e.g. prescription of drug " Fabulanova " .

>

>I think it is fair to say that every trial is a study, but many studies are

>not trials.

>

>My training makes me doubt and question everything I say, but I think these

>statements hold. Anybody care to correct or contradict me on any point?

>

>Best regards

>Coilín.

>

>

>Coilín ÓhAiseadha. da>en no>en translator

>Aa-Tchoo! Entertainments Translations: www.aatchoo.com

>Tsentsak Medical Translations: tsentsak@...

>+45 3616 5666 / 2192 5666

>

>

>URL: http://groups.yahoo.com/group/medical_translation

>

>To unsubscribe, please send an *empty* message to

>medical_translation-UNSUBSCRIBE

>

>

[Guest guest]

Sorry, just said it off the top of my head without checking. I gather that

the animal/tissue/cell studies are pre-trial studies.

Barbara

Re: etude d'enregistrement = clinical trial?

> Barbara :

> >(phase I

> >studies in experimental animals)

>

> I don't think these are Phase I. Phase I is in human volunteers/healthy

> subjects or whatever other human baseline that is appropriate. It is a

> human safety/tolerability study. Animal studies are done before that

> (potential efficacy, safety, etc)

> --

> Maarten de Bruijn PhD, AITI matmed@...

> 19 Belmont Avenue Tel: 0044 1625 422797

> Macclesfield Medical/pharmaceutical/financial

> Cheshire SK10 3JN, UK Dutch<>English

>

> URL: http://groups.yahoo.com/group/medical_translation

>

> To unsubscribe, please send an *empty* message to

> medical_translation-UNSUBSCRIBE

>

>

[Guest guest]

At 00:31 19-05-01 +0100, Owen wrote:

>Sounds reasonable. This is one of those questions you always want to ask

>but never do, partly out of fear of becoming the translators' equivalent of

>the man in a Bateman cartoon! By the way what does 'Fabulanova' do

Registration trials revealed side effects including the following in the

first patient in the trial:

cough

wheeze and bronchospasm

recurrent sneezing

rhinorrhoea

xerostomia

aphthous ulceration of the buccal mucosa

nausea and vomiting

intermittent diarrhoea and constipation

tenesmus

tremors

hypotonia

hyperreflexia

rigidity

strabismus

dysdiadochokinesis

haematuria

intermittent priapism and impotence

paroxysmal tachy- and bradycardia

- resulting in palpitations and syncope

intermittent presbyopia

proptosis

muscae volitante

nominal dysphasia

arthralgia of the right elbow and left second toe

axillary lymphadenopathy

petechial rash

pedal hirsutism

peau d'orange and

paraesthesia in the area of the chin and neck.

On the basis of this, the trial was discontinued before a second subject

was enrolled into the trial and we'll probably never know whether it has

any efficacy as an antidepressant.

>and is

>it available ovathacounta?

Unfortunately not. Would you like a prescription?

Best regards,

Coilín.

> >

> >Nor do I think a retrospective study can be called a trial, even if we are

> >comparing two groups of patients, of which one was treated with tamoxifen

> >and another received no treatment. I think a trial is essentially

> >prospective and involves the study of a particular therapeutic measure,

> >e.g. prescription of drug " Fabulanova " .

Coilín ÓhAiseadha. da>en no>en translator

Aa-Tchoo! Entertainments Translations: www.aatchoo.com

Tsentsak Medical Translations: tsentsak@...

+45 3616 5666 / 2192 5666

[Guest guest]

At 00:31 19-05-01 +0100, Owen wrote:

>Sounds reasonable. This is one of those questions you always want to ask

>but never do, partly out of fear of becoming the translators' equivalent of

>the man in a Bateman cartoon! By the way what does 'Fabulanova' do

Registration trials revealed side effects including the following in the

first patient in the trial:

cough

wheeze and bronchospasm

recurrent sneezing

rhinorrhoea

xerostomia

aphthous ulceration of the buccal mucosa

nausea and vomiting

intermittent diarrhoea and constipation

tenesmus

tremors

hypotonia

hyperreflexia

rigidity

strabismus

dysdiadochokinesis

haematuria

intermittent priapism and impotence

paroxysmal tachy- and bradycardia

- resulting in palpitations and syncope

intermittent presbyopia

proptosis

muscae volitante

nominal dysphasia

arthralgia of the right elbow and left second toe

axillary lymphadenopathy

petechial rash

pedal hirsutism

peau d'orange and

paraesthesia in the area of the chin and neck.

On the basis of this, the trial was discontinued before a second subject

was enrolled into the trial and we'll probably never know whether it has

any efficacy as an antidepressant.

>and is

>it available ovathacounta?

Unfortunately not. Would you like a prescription?

Best regards,

Coilín.

> >

> >Nor do I think a retrospective study can be called a trial, even if we are

> >comparing two groups of patients, of which one was treated with tamoxifen

> >and another received no treatment. I think a trial is essentially

> >prospective and involves the study of a particular therapeutic measure,

> >e.g. prescription of drug " Fabulanova " .

Coilín ÓhAiseadha. da>en no>en translator

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