Six Reasons to Disclose Clinical Trial Information

April 20, 2016 Francine Lane

Why disclose?

There are many reasons to register clinical trials on a public registry.  Here are some key considerations. 

Transparency

  1.        Legal obligation:

Several countries, such as the United States Food and Drug Amendments Act of 2007, Section 801. and Europe’s Clinical trials - Regulation EU No 536/2014 (the Clinical Trials Directive 2001/20/EC is active until the new regulation is fully in effect) require clinical trial information, including results, to be disclosed.

  1.        Publication requirement:

The International Committee of Medical Journal Editors (ICMJE) has a policy that all medical journals should require the registration of clinical trials on a WHO Primary Registry as a prerequisite to publication.

  1.        Organization policy:

Companies, academic institutions, and other research facilities have policies on disclosing clinical trial information.  At a minimum, these policies state that all legal requirements must be met, and some policies exceed the legal obligations.

  1.        Industry organization:

Many industry organizations have published policies on clinical trial conduct and data sharing such as , the Pharmaceutical Research and Manufacturers of America (PhRMA) PhRMA Principles on Conduct of Clinical Trials, Biotechnology Industry Organization (BIO) BIO Principles on Clinical Trial Data Sharing, and the European Federation of Pharmaceutical Industries and Associations EFPIA policy statement on Clinical Trials Regulation to provide just a few.  It is a fairly safe bet that if you belong to an industry organization, there is a policy on clinical trial disclosure and clinical trial results reporting.

  1.        Grant requirement:

In 2014, the National Institutes of Health (NIH) proposed a policy that all studies that are fully or partially funded by the NIH be registered and basic results are disclosed.

  1.        Ethics and better science:
Several organizations call for ethical conduct for research in humans.  The Declaration of Helsinki, first adopted by the World Medical Association (WMA) in 1964, was amended in 2013 with specific language around disclosure and transparence:   WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
The AllTrials initiative “calls for all past and present clinical trials to be registered and their full methods and summary results reported.”

Want to find out more?

Download TrialScope's whitepaper: Introduction to Clinical Trial Disclosure 

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Check out a related blog: Introduction to Clinical Trial Disclosure

 

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