Re: Ethics in the design of clinical research

[Guest guest]

Dear members,

Placebos are inert, non-biologically

active agents used in the clinical trials of experimental drugs or other

therapies. The typical placebo is a pill made to look like an experimental

drug, the purpose of which is to fool the research participant as well as the

researchers about whether a participant is getting the drug or not.

Placebos are not the same as no treatment

at all, because placebos are known to elicit physiological effects. For

example, a typical placebo trial may show that some 20 to 30 percent of

participants “benefit†or show improvement on the outcomes being studied. This

provides a standard that must be exceeded by an experimental treatment.

As per Declaration of Helsinki (2008):

-The benefits, risks, burdens and

effectiveness of a new intervention must be tested against those of the best

current proven intervention, except in the following circumstances:

The use of placebo, or no treatment, is

acceptable in studies where no current proven intervention exists; or

Where for compelling and scientifically

sound methodological reasons the use of placebo is necessary to determine the

efficacy or safety of an intervention and the patients who receive placebo or

no treatment will not be subject to any risk of serious or irreversible harm.

Extreme care must be taken to avoid abuse of this option.

-All other provisions of the Declaration

of Helsinki must be adhered to, especially the need for appropriate ethical and

scientific review.

Placebo-controlled trials (PCTs) have been

the subject of vigorous debate in recent years. Debate has concerned both whether

such trials are ethical and whether they are scientifically necessary. The goal

of this section is to discuss

-whether PCTs are ethical?

-what are some scientific reasons for

using a placebo arm in a clinical research study?

-why these reasons often remain despite

the existence of standard therapy?

Regards,Dr. Mangesh, Nagpur

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Dear Dr Mangesh

As per recent studies, it is said that placebos also possess pharmacological effect. some with positive or negative effects. Sometimes it is considered as physiological response or psychological effect of intervenions. If this is the case then i think placebos can also be used as interventions for various indications. Research on use of placebos for the treatment of various ailments like Epilepsy, Alzheimer's disease etc. is undergoing.

I just want to emphasize on ethical use of placebos in clinical trials. Ethically it is permissible to use placebos in case standard intevention is not available as comparator.

To prove the safety and efficacy of new intervenion, we need comparator (either placebo or standard intervention).

Thanks and regards

TARUN WADHWA

SENIOR RESEARCH FELLOW

DEPARTMENT OF PHARMACOLOGY

J N MEDICAL COLLEGE

NEHRU NAGAR, BELGAUM-590010

KARNATAKA, INDIA

PH: 09844564634

E.MAIL: pharmamanipal@...

From: mangesh bankar <drmangesh_bankar@...>Subject: Re: Ethics in the design of clinical researchnetrum Date: Monday, 28 December, 2009, 12:15 PM

Dear members,

Placebos are inert, non-biologically active agents used in the clinical trials of experimental drugs or other therapies. The typical placebo is a pill made to look like an experimental drug, the purpose of which is to fool the research participant as well as the researchers about whether a participant is getting the drug or not.

Placebos are not the same as no treatment at all, because placebos are known to elicit physiological effects. For example, a typical placebo trial may show that some 20 to 30 percent of participants “benefit†or show improvement on the outcomes being studied. This provides a standard that must be exceeded by an experimental treatment.

As per Declaration of Helsinki (2008):

-The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.

-All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

Placebo-controlled trials (PCTs) have been the subject of vigorous debate in recent years. Debate has concerned both whether such trials are ethical and whether they are scientifically necessary. The goal of this section is to discuss

-whether PCTs are ethical?

-what are some scientific reasons for using a placebo arm in a clinical research study?

-why these reasons often remain despite the existence of standard therapy?Regards,Dr. Mangesh, Nagpur

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Dear members

I think use of placebos in clinical trials is still a debatable issue but if it is justifiable without compromising health of the subjects then i think its use can be permitted.

Still it depends on the situation, type of study, interventions and the outcome being studied.

Thanks to Dr Mangesh for disussing these issues and rectifying queries.

Thanks and Regards

TARUN WADHWA

SENIOR RESEARCH FELLOW

DEPARTMENT OF PHARMACOLOGY

J N MEDICAL COLLEGE

NEHRU NAGAR, BELGAUM-590010

KARNATAKA, INDIA

PH: 09844564634

E.MAIL: pharmamanipal@...

From: mangesh bankar <drmangesh_bankar@ .co. in>Subject: Re: Ethics in the design of clinical researchnetrumgroups (DOT) comDate: Monday, 28 December, 2009, 12:15 PM

Dear members,

Placebos are inert, non-biologically active agents used in the clinical trials of experimental drugs or other therapies. The typical placebo is a pill made to look like an experimental drug, the purpose of which is to fool the research participant as well as the researchers about whether a participant is getting the drug or not.

Placebos are not the same as no treatment at all, because placebos are known to elicit physiological effects. For example, a typical placebo trial may show that some 20 to 30 percent of participants “benefit†or show improvement on the outcomes being studied. This provides a standard that must be exceeded by an experimental treatment.

As per Declaration of Helsinki (2008):

-The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option. -All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

Placebo-controlled trials (PCTs) have been the subject of vigorous debate in recent years. Debate has concerned both whether such trials are ethical and whether they are scientifically necessary. The goal of this section is to discuss

-whether PCTs are ethical? -what are some scientific reasons for using a placebo arm in a clinical research study? -why these reasons often remain despite the existence of standard therapy?Regards,Dr. Mangesh, Nagpur

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Dear members,

There are at least 5 sound scientific

reasons a placebo arm might be used. They are:

(1) Ensuring the scientific validity of

the clinical trial (assay sensitivity),

(2) Evaluating new therapies that are

promising but less potent than the gold standard,

(3) Minimizing the number of patients

exposed to potentially inefficacious or toxic therapy,

(4) Studying common clinical situations in

which withdrawal of therapy might be considered, and

(5) Determining the true incidence of

adverse events (side effects) associated with therapy.

These considerations will

discussed here in detail.Regards,Dr. Mangesh,Nagpur

From: mangesh bankar <drmangesh_bankar@ .co. in>Subject: Re: Ethics in the design of clinical researchnetrumgroups (DOT) comDate: Monday, 28 December, 2009, 12:15 PM

Dear members,

Placebos are inert, non-biologically active agents used in the clinical trials of experimental drugs or other therapies. The typical placebo is a pill made to look like an experimental drug, the purpose of which is to fool the research participant as well as the researchers about whether a participant is getting the drug or not.

Placebos are not the same as no treatment at all, because placebos are known to elicit physiological effects. For example, a typical placebo trial may show that some 20 to 30 percent of participants “benefit†or show improvement on the outcomes being studied. This provides a standard that must be exceeded by an experimental treatment.

As per Declaration of Helsinki (2008):

-The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option. -All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

Placebo-controlled trials (PCTs) have been the subject of vigorous debate in recent years. Debate has concerned both whether such trials are ethical and whether they are scientifically necessary. The goal of this section is to discuss

-whether PCTs are ethical? -what are some scientific reasons for using a placebo arm in a clinical research study? -why these reasons often remain despite the existence of standard therapy?Regards,Dr. Mangesh, Nagpur

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Hi,

Placebo as single arm in epilepsy? Which EC allowed this? Give full details and

I will question them. The permitting EC must be having ignorant buffoons as

members. They can be sued in the court of law and damages claimed by the NOK

(next of kin)of patients for having caused serious harm to them.

Read my earlier post to this one to understand the issue.

Dr Vijay Thawani

>

>

> From: mangesh bankar <drmangesh_bankar@...>

> Subject: Re: Ethics in the design of clinical research

> netrum

> Date: Monday, 28 December, 2009, 12:15 PM

>

>

>  

>

>

>

>

>

>

>

> Dear members,

>

>

> Placebos are inert, non-biologically active agents used in the clinical trials

of experimental drugs or other therapies. The typical placebo is a pill made to

look like an experimental drug, the purpose of which is to fool the research

participant as well as the researchers about whether a participant is getting

the drug or not.

> Placebos are not the same as no treatment at all, because placebos are known

to elicit physiological effects. For example, a typical placebo trial may show

that some 20 to 30 percent of participants “benefit†or show improvement on

the outcomes being studied. This provides a standard that must be exceeded by an

experimental treatment.

> As per Declaration of Helsinki (2008):

> -The benefits, risks, burdens and effectiveness of a new intervention must be

tested against those of the best current proven intervention, except in the

following circumstances:

> The use of placebo, or no treatment, is acceptable in studies where no current

proven intervention exists; or

> Where for compelling and scientifically sound methodological reasons the use

of placebo is necessary to determine the efficacy or safety of an intervention

and the patients who receive placebo or no treatment will not be subject to any

risk of serious or irreversible harm. Extreme care must be taken to avoid abuse

of this option.

> -All other provisions of the Declaration of Helsinki must be adhered to,

especially the need for appropriate ethical and scientific review.

>  

> Placebo-controlled trials (PCTs) have been the subject of vigorous debate in

recent years. Debate has concerned both whether such trials are ethical and

whether they are scientifically necessary. The goal of this section is to

discuss

> -whether PCTs are ethical?

> -what are some scientific reasons for using a placebo arm in a clinical

research study?

> -why these reasons often remain despite the existence of standard therapy?

>

> Regards,

>

> Dr. Mangesh,

> Nagpur

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

>

>

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

http://in./

>

[Guest guest]

Hi,

I respect the views of Mangesh but am not fully convinced.

Who has suggested these 5 points, when and where?

I will be thankful if you can provide full reference, if any.

Thanks

Dr Vijay Thawani

>

>

> From: mangesh bankar <drmangesh_bankar@ .co. in>

> Subject: Re: Ethics in the design of clinical research

> netrumgroups (DOT) com

> Date: Monday, 28 December, 2009, 12:15 PM

>

>

>  

>

>

>

>

>

> Dear members,

>

>

> Placebos are inert, non-biologically active agents used in the clinical trials

of experimental drugs or other therapies. The typical placebo is a pill made to

look like an experimental drug, the purpose of which is to fool the research

participant as well as the researchers about whether a participant is getting

the drug or not.

>

> Placebos are not the same as no treatment at all, because placebos are known

to elicit physiological effects. For example, a typical placebo trial may show

that some 20 to 30 percent of participants “benefit†or show improvement on

the outcomes being studied. This provides a standard that must be exceeded by an

experimental treatment.

>

> As per Declaration of Helsinki (2008):

>

> -The benefits, risks, burdens and effectiveness of a new intervention must be

tested against those of the best current proven intervention, except in the

following circumstances:

> The use of placebo, or no treatment, is acceptable in studies where no current

proven intervention exists; or

> Where for compelling and scientifically sound methodological reasons the use

of placebo is necessary to determine the efficacy or safety of an intervention

and the patients who receive placebo or no treatment will not be subject to any

risk of serious or irreversible harm. Extreme care must be taken to avoid abuse

of this option.

> -All other provisions of the Declaration of Helsinki must be adhered to,

especially the need for appropriate ethical and scientific review.

>  

> Placebo-controlled trials (PCTs) have been the subject of vigorous debate in

recent years. Debate has concerned both whether such trials are ethical and

whether they are scientifically necessary. The goal of this section is to

discuss

> -whether PCTs are ethical?

> -what are some scientific reasons for using a placebo arm in a clinical

research study?

> -why these reasons often remain despite the existence of standard therapy?

>

> Regards,

>

> Dr. Mangesh,

> Nagpur

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

>

>

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

http://in./

>

[Guest guest]

Hi,

The placebo controlled CTs sponsored by pharmaceutical industry are permitted by

the ECs of the developing world because the members of these ECs live in fool's

paradise, are not trained in CTs, do not update themselves, have never performed

any CT as PI, are happy with the fee collected from applicants, some get grease

in the form of dinners in top end hotels and gifts from the sponsoring company.

Who bothers for the poor patient participants? The juniors think ECs are doing

swell job and revere the boss considering " boss is always right " !!

Vijay

>

> >

>

> >

>

> > From: mangesh bankar <drmangesh_bankar@ ...>

>

> > Subject: Re: Ethics in the design of clinical research

>

> > netrumgroups (DOT) com

>

> > Date: Monday, 28 December, 2009, 12:15 PM

>

> >

>

> >

>

> >  

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> > Dear members,

>

> >

>

> >

>

> > Placebos are inert, non-biologically active agents used in the clinical

trials of experimental drugs or other therapies. The typical placebo is a pill

made to look like an experimental drug, the purpose of which is to fool the

research participant as well as the researchers about whether a participant is

getting the drug or not.

>

> > Placebos are not the same as no treatment at all, because placebos are known

to elicit physiological effects. For example, a typical placebo trial may show

that some 20 to 30 percent of participants “benefit†or show improvement on

the outcomes being studied. This provides a standard that must be exceeded by an

experimental treatment.

>

> > As per Declaration of Helsinki (2008):

>

> > -The benefits, risks, burdens and effectiveness of a new intervention must

be tested against those of the best current proven intervention, except in the

following circumstances:

>

> > The use of placebo, or no treatment, is acceptable in studies where no

current proven intervention exists; or

>

> > Where for compelling and scientifically sound methodological reasons the use

of placebo is necessary to determine the efficacy or safety of an intervention

and the patients who receive placebo or no treatment will not be subject to any

risk of serious or irreversible harm. Extreme care must be taken to avoid abuse

of this option.

>

> > -All other provisions of the Declaration of Helsinki must be adhered to,

especially the need for appropriate ethical and scientific review.

>

> >  

>

> > Placebo-controlled trials (PCTs) have been the subject of vigorous debate in

recent years. Debate has concerned both whether such trials are ethical and

whether they are scientifically necessary. The goal of this section is to

discuss

>

> > -whether PCTs are ethical?

>

> > -what are some scientific reasons for using a placebo arm in a clinical

research study?

>

> > -why these reasons often remain despite the existence of standard therapy?

>

> >

>

> > Regards,

>

> >

>

> > Dr. Mangesh,

>

> > Nagpur

>

> >

>

> >

>

> >

>

> > The INTERNET now has a personality. YOURS! See your Homepage.

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> > The INTERNET now has a personality. YOURS! See your Homepage.

http://in.. com/

>

> >

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>

>

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> The INTERNET now has a personality. YOURS! See your Homepage.

http://in./

>

[Guest guest]

Dear Vijay sir,I welcome your critcism regarding arguments supporting use of placebo in clincal trials. These

are the arguments made by proponents of placebo-controlled trials. These are

not guidelines to be followed by everyone. Though I have posted these

considerations here, that doesn’t mean that I am also supporting them.

I

strongly support the Declaration of Helsinki which states that it is unethical

to withhold a therapy of proven efficacy from any patient in a research trial

just for the purpose of increasing scientific knowledge. Paragraph 29 of the Declaration

of Helsinki states: “The benefits, risks, burdens and effectiveness of a new

method should be tested against those of the best current prophylactic,

diagnostic, and therapeutic methodsâ€. A note of clarification for paragraph 29

states: “The World Medical Association hereby reaffirms its position that

extreme care must be taken in making use of a placebo-controlled trial and that

in general this methodology should only be used in the absence of existing

proven therapyâ€

Many

supporters of the declaration of Helsinki

suggest that declaration should include specific examples showing how placebo

trials are unethical: For example, even in studies of new analgesics to study

relief from pain such as headache, the new remedies should be compared only

with existing analgesics, and never with placebo. The example will reinforce

the point that this principle is not a blurry boundary.

Critics

of the declaration argue that forbidding placebo trials puts the manufacturers

of a new treatment at a scientific and commercial disadvantage. The

manufacturers of a new treatment, have to prove that their treatment is as good

as an existing one, also they had to pass a “lesser test†(superiority over

placebo) to get their drug on the market. In my opinion, person benefiting from

the placebo control trial is not the patient but such trial benefit only to

investigator or the manufacturer.

Regards,Dr. Mangesh,Nagpur.From: Vijay <drvijaythawani@...>Subject: Re: Ethics in the design of clinical researchnetrum Date: Monday, 28 December, 2009, 7:31 PM

Hi,

I respect the views of Mangesh but am not fully convinced.

Who has suggested these 5 points, when and where?

I will be thankful if you can provide full reference, if any.

Thanks

Dr Vijay Thawani

>

>

> From: mangesh bankar <drmangesh_bankar@ .co. in>

> Subject: Re: Ethics in the design of clinical research

> netrumgroups (DOT) com

> Date: Monday, 28 December, 2009, 12:15 PM

>

>

>

>

>

>

>

>

> Dear members,

>

>

> Placebos are inert, non-biologically active agents used in the clinical trials of experimental drugs or other therapies. The typical placebo is a pill made to look like an experimental drug, the purpose of which is to fool the research participant as well as the researchers about whether a participant is getting the drug or not.

>

> Placebos are not the same as no treatment at all, because placebos are known to elicit physiological effects. For example, a typical placebo trial may show that some 20 to 30 percent of participants “benefit†or show improvement on the outcomes being studied. This provides a standard that must be exceeded by an experimental treatment.

>

> As per Declaration of Helsinki (2008):

>

> -The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

> The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

> Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.

> -All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

>

> Placebo-controlled trials (PCTs) have been the subject of vigorous debate in recent years. Debate has concerned both whether such trials are ethical and whether they are scientifically necessary. The goal of this section is to discuss

> -whether PCTs are ethical?

> -what are some scientific reasons for using a placebo arm in a clinical research study?

> -why these reasons often remain despite the existence of standard therapy?

>

> Regards,

>

> Dr. Mangesh,

> Nagpur

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

>

>

>

>

>

> The INTERNET now has a personality. YOURS! See your Homepage.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

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>

> The INTERNET now has a personality. YOURS! See your Homepage. http://in.. com/

>

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Hi,

Well said dear moderator.

I am proud of your understanding.

Vijay

>

> >

>

> >

>

> > From: mangesh bankar <drmangesh_bankar@ .co. in>

>

> > Subject: Re: Ethics in the design of clinical research

>

> > netrumgroups (DOT) com

>

> > Date: Monday, 28 December, 2009, 12:15 PM

>

> >

>

> >

>

> >  

>

> >

>

> >

>

> >

>

> >

>

> >

>

> > Dear members,

>

> >

>

> >

>

> > Placebos are inert, non-biologically active agents used in the clinical

trials of experimental drugs or other therapies. The typical placebo is a pill

made to look like an experimental drug, the purpose of which is to fool the

research participant as well as the researchers about whether a participant is

getting the drug or not.

>

> >

>

> > Placebos are not the same as no treatment at all, because placebos are known

to elicit physiological effects. For example, a typical placebo trial may show

that some 20 to 30 percent of participants “benefit†or show improvement on

the outcomes being studied. This provides a standard that must be exceeded by an

experimental treatment.

>

> >

>

> > As per Declaration of Helsinki (2008):

>

> >

>

> > -The benefits, risks, burdens and effectiveness of a new intervention must

be tested against those of the best current proven intervention, except in the

following circumstances:

>

> > The use of placebo, or no treatment, is acceptable in studies where no

current proven intervention exists; or

>

> > Where for compelling and scientifically sound methodological reasons the use

of placebo is necessary to determine the efficacy or safety of an intervention

and the patients who receive placebo or no treatment will not be subject to any

risk of serious or irreversible harm. Extreme care must be taken to avoid abuse

of this option.

>

> > -All other provisions of the Declaration of Helsinki must be adhered to,

especially the need for appropriate ethical and scientific review.

>

> >  

>

> > Placebo-controlled trials (PCTs) have been the subject of vigorous debate in

recent years. Debate has concerned both whether such trials are ethical and

whether they are scientifically necessary. The goal of this section is to

discuss

>

> > -whether PCTs are ethical?

>

> > -what are some scientific reasons for using a placebo arm in a clinical

research study?

>

> > -why these reasons often remain despite the existence of standard therapy?

>

> >

>

> > Regards,

>

> >

>

> > Dr. Mangesh,

>

> > Nagpur

>

> >

>

> >

>

> >

>

> > The INTERNET now has a personality. YOURS! See your Homepage.

>

> >

>

> >

>

> >

>

> > The INTERNET now has a personality. YOURS! See your Homepage.

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> > The INTERNET now has a personality. YOURS! See your Homepage.

>

> >

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> >

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> >

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> >

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> >

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> >

>

> > The INTERNET now has a personality. YOURS! See your Homepage.

http://in.. com/

>

> >

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> The INTERNET now has a personality. YOURS! See your Homepage.

http://in./

>