NLM Director’s Comments Transcript
More Transparent Clinical Trials: A Possible Boost, 01/14/2013

Greetings from the National Library of Medicine and MedlinePlus.gov

Regards to all our listeners!

I'm Rob Logan, Ph.D. senior staff National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.

Here is what's new this week in MedlinePlus.

In an interesting change of policy, BMJ (a major international medical journal) recently announced it will publish clinical trial results for medical drugs and devices only if authors commit to making a trial’s underlying detailed data publicly available if requested.

While BMJ is not the first medical journal to initiate this policy (the Annals of Internal Medicine and PLoS Medicine have similar requirements), the move towards requiring more clinical trial transparency seems to be a growing trend. While these journals ask authors to share detailed trial results, all patient results are de-identified, or anonymous.

In a recent editorial, BMJ’s editors explain the journal’s change is (and we quote) ‘just one step up from our current policy: since 2009 we have encouraged authors to share their data on request and have required them to say whether they will or not’ (end of quote).

However, the authors explain BMJ’s move from encouraging to committing authors is to achieve a more rigorous and independent scrutiny of medical trials and devices, and make the entire process to develop them more transparent to health care professionals and the public.

The authors succinctly explain (and we quote): ‘Why the new policy? Because it is no longer possible to pretend that a report of a clinical trial in a medical journal is enough to allow full independent scrutiny of the results’ (end of quote).

BMJ’s editors suggest more journals may follow their lead and they hope the International Committee of Medical Journal Editors (of which BMJ is a member) will (and we quote) ‘take a decisive lead’ (end of quote).

In response to BMJ’s announcement, a U.S. pharmaceutical industry spokesperson told the New York Times the detailed release of trial results could lead to their misinterpretation. He added the pharmaceutical industry is concerned about protecting patient confidentiality when more detailed results become available for open scrutiny.

In their editorial, BMJ’s editors acknowledge these are among the issues that need further resolution by: medical researchers, trial sponsors, corporations, academic institutions, medical centers, as well as government pharmaceutical and medical device regulators.

In a story about BMJ’s announcement, the New York Times adds the public already has access to an overview of medical device and drug results. Although not specifically mentioned, the Times refers to the overviews of clinical trial results that have been available via NLM’s clinicaltrials.gov since fall 2008. (We indirectly mention clinicaltrials.gov in podcasts whenever we encourage listeners to click on a link within MedlinePlus that provides information about clinical trials which may be occurring in your area).

In a story about BMJ’s announcement, the New York Times adds the public already has access to an overview of medical device and drug results. Although not specifically mentioned, the Times refers to the overviews of clinical trial results that have been available via NLM’s clinicaltrials.gov since fall 2008. (We indirectly mention clinicaltrials.gov in podcasts whenever we encourage listeners to click on a link within MedlinePlus that provides information about clinical trials which may be occurring in your area).

The Times suggests BMJ’s announcement — coupled with the existing overview information available within clinicaltrials.gov — should result in a higher level of detail and transparency about drug and device clinicaltrials.gov.

Overall, BMJ’s editors hope their policy shift eventually will boost the comprehensive disclosure of clinical trial results, which ultimately will be a boost to public health.

 Meanwhile, you can find some overview-results of clinical trials within clinicaltrials.gov by typing a name of a disease, condition, drug, device, or sponsor within the search box on the left side near the top of clinicaltrials.gov’s home page. Then, look for the headline ‘has results’ within the ensuing list and click on the trial’s name.

MedlinePlus.gov’s understanding medical research health topic page also provides an overview of frequently asked questions about clinical research (from the Human Genome Research Institute) in the ‘start here’ section. A webpage devoted to explaining clinical research and clinical trials (provided by the National Institute of Child Health and Human Development) is available within the ‘overviews’ section of MedlinePlus.gov’s understanding medical research health topic page.

MedlinePlus.gov additionally has a health topic page devoted to clinical trials. Among other resources, there is an excellent overview of clinical trial procedures (from the National Institutes of Health) in the ‘start here’ section of MedlinePlus.gov’s clinical trials health topic page. You can find answers to basic questions about clinical trials (provided by the U.S. Food and Drug Administration) in the ‘overviews’ section of MedlinePlus.gov’s clinical trials health topic page.

To find MedlinePlus.gov’s clinical trials health topic page, type ‘clinical trials’ in the search box at the top of MedlinePlus.gov’s home page. To find MedlinePlus.gov’s understanding medical research health topic page, type ‘understanding medical research’ in the search box at the top of MedlinePlus.gov’s home page.

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I hope you have a very happy holiday season and enjoy a healthy New Year. The National Library of Medicine and the ‘Director’s Comments’ podcast staff, including Dr. Lindberg, appreciate your interest and company — and we hope to find new ways to serve you in 2013.