Organon launches publically accessible website on its clinical trials

[Guest guest]

Organon launches publically accessible website on its clinical trials

19 Jun 2005 Medical News Today

Organon announced the launch of a clinical trial website -

www.organon-trials.com - that will provide results of the company's

completed trials and a registry of ongoing trials. The website will

further increase the transparency of the clinical trials Organon

sponsors. The site is freely accessible without restriction.

" Organon is committed to provide transparency about the trials we

conduct by making this information available in the public domain. We

are pleased to be one of the first pharmaceutical companies to

introduce such an initiative, " commented Dr Henk Jan Out, Head of

Global Clinical Development at Organon. With this action, Organon

follows the recommendation from the joint pharmaceutical company

associations and editors of the major medical journals.

The clinical trial registry contains information on all phase III and

beyond trials currently taking place. [1] This includes a unique

identifying number, purpose of the study, study type and design,

eligibility criteria, target number of patients, countries where the

study is running and contact information.

The clinical trial results section will summarize the findings of the

clinical trials that have been performed with currently available

major products of Organon. The number will grow as additional older

trials are added. In addition, once trials posted on the registry

have been completed and marketing approval gained in one country, the

results from all studies - including those preceding the phase III

trials - will be posted in the clinical trial results section.

Similarly, Organon will also report results of earlier trials when

already marketed drugs have been approved in new indications.

Both the registry and results sections provide scientific, non-

promotional and comprehensive summaries of clinical trials in a

consistent format irrespective of whether the results may be viewed

as positive or negative for the medicine concerned. The site will be

updated regularly to ensure the information is accurate and up-to-

date.

Dr Out added: " Patients who volunteer to take part in clinical trials

deserve to know that their contribution to improving medical

knowledge will be available without restriction. This new site will

ensure this is the case for our products. "

Dr Out also stressed that the information on the site is not intended

to promote or otherwise commercialize any off-label or unapproved use

of any Organon medicine. He further drew attention to the fact that

health care professionals should consult prescribing information

approved in their country, before prescribing any product mentioned

on the site.

Organon - with shared head offices in Roseland, New Jersey, U.S.A.

and Oss, The Netherlands - creates, manufactures and markets

prescription medicines that improve the health and quality of human

life. Through a combination of independent growth and business

partnerships, Organon strives to remain or become one of the leading

pharmaceutical companies in each of its core therapeutic fields:

reproductive medicine, psychiatry and anesthesia. Organon products

are sold in over 100 countries, of which more than 60 have an Organon

subsidiary. Organon is the human health care business unit of Akzo

Nobel. Additional information about Organon is available through its

corporate website, http://www.organon.com.

1- Phase III studies are those studies in which the efficacy and

safety of a drug is compared with that of placebo and other active

compounds in trials typically involving 3,000 to 5,000 patients

representative of the population who will ultimately receive the

treatment. On completion, files of data can be submitted to

regulatory authorities with a request for marketing authorization.

Phase III studies follow earlier studies - preclinical and early

clinical development studies - suggesting effectiveness of a drug.

http://www.organon.com