Widening the window on clinical trials: 03/14/2016
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I'm Rob Logan, Ph.D., senior staff, U.S. National Library of Medicine.
Here is what's new this week in To Your Health, a consumer health oriented podcast from NLM, that helps you use MedlinePlus to follow up on weekly topics.
The editors of 14 leading international medical journals recently said they will require more sharing of the patient data underlying clinical trial research as a requisite to consider a submission for publication.
In a joint statement, the International Committee of Medical Journal Editors (ICMJE) said they will require all authors to submit a plan to share the broader patient data collected for their currentresearch — starting in about a year. The self-imposed requirement will (and we quote): 'require authors to share with others the de-identified individual patient data underlying the results presented in the article... no later than six months after publication' (end of quote).
Essentially, the decision means some of the datasets that undergird the extensive information gathered in clinical trials eventually will be more available to other researchers for re-assessment and will be placed in repositories where they may be publicly accessible. Overall, this widens the window into the clinical trial process.
While some trial summary data currently are provided within the results section of clinicaltrials.gov, the additional requirement also potentially provides a gateway to evaluate the clinical trial results published in major journals by public interest health organizations, public health and medical students, health care journalists, and others.
In a written statement, ICMJE explains (and we quote): 'there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk' (end of quote).
ICMJE adds (and we quote): 'sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of the results, an essential tenet of the scientific process... It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society' (end of quote).
ICMJE explains a 12 month implementation delay provides university and institutional review boards sufficient time to obtain the informed consent of clinical trial participants and implement a process to share data within existing health data repositories.
Overall, the decision continues a tradition of leadership within ICMJE regarding the openness and access to clinical trial information, which includes the organization's 2005 decision to require the registration of all clinical trials within clinicaltrials.gov (or similar repositories) as a requisite for consideration of a submission for publication (as well as to initiate participant enrollment).
However, while ICMJE supports the concept of data sharing, a recent editorial co-written by a member (who is the editor of the New England Journal of Medicine), notes there may be potential challenges such as misinterpreting a study's parameters, or the creation of 'data parasites,' who publish by using others' data without conducting original research.
Meanwhile, some basic questions and answers about how clinical trials are conducted (provided by the National Human Genome Research Institute) are available within MedlinePlus.gov's clinical trials health topic page.
The National Heart, Lung, and Blood Institute discusses the risks and benefits of clinical trials within the 'related issues' section of MedlinePlus.gov's clinical trials health topic page. The National Heart, Lung, and Blood Institute also carefully explains the importance of - and participation in - clinical trials in a video within the 'videos and tutorials' section of MedlinePlus.gov's clinical trials health topic page.
MedlinePlus.gov's clinical trials health topic page additionally provides links to the latest pertinent journal research articles, which are available in the 'journal articles' section. You can sign up to receive updates about clinical trials as they become available on MedlinePlus.gov.
To find MedlinePlus.gov's clinical trials health topic page please type 'clinical trials' in the search box on MedlinePlus.gov's home page, then, click on 'clinical trials (National Library of Medicine).'
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