Organon launches publically accessible website on its clinical trials
"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.
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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
Organon lanseazã public accesibil pe site-ul sãu studiile clinice - Organon launches publically accessible website on its clinical trials - articole medicale engleza - startsanatate