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BMJ: Clinical trial data for all drugs in current use must be available for independent scrutiny

In an impassioned editorial, BMJ editor Fiona Godlee calls on the pharmaceutical industry to release clinical trial data on all approved drugs, and on medical journals to publish industry-funded trials only when there is a commitment to make patient-level data available on reasonable request.  She states that the BMJ will require this commitment for all clinical trials of drugs and devices, whether industry-funded or not, beginning in January 2013.  In addition, BMJ is publishing online all correspondence between Roche and the Cochrane Collaboration researchers regarding the oseltamivir (Tamiflu) data.  More on the battle for Tamiflu data here.

Addendum 11/2/2012:  read Pharmalot’s coverage here.

BMJ editor: Open letter to Roche about oseltamivir trial data

In BMJ:

Roche promised in 2009 to release full reports from clinical trials of oseltamivir in response to an investigation by the BMJ and the Cochrane Collaboration.  In this open letter to John Bell, regius professor of medicine at Oxford University and a Roche board member, the BMJ’s editor in chief further urges the company to disclose the full data.

Read the full letter here.

Background here.

More commentaries on data sharing

In the May 2012 issue of The Scientist, Data Diving:  What lies untapped beneath the surface of published clinical trial analyses could rock the world of independent review.  Discusses the problem of missing data and how it affects the reliability of systematic reviews.

On the Scientific American website, a guest post by cardiologist and researcher Jalees Rehman, Open Science and Access to Medical Research.  Rehman discusses the special challenges of sharing clinical research, including the need to maintain patient confidentiality and the need for independent institutions to interpret the data in an unbiased manner so that vulnerable patients are not misled or given false hope.

In the November 21, 2011 issue of the Medical Journal of Australia, Time to mandate data release and independent audits for all clinical trials, by Ian Haines and George Gabor Miklos.  Here are the last two paragraphs:

Medical journals and their editors have a choice — to be viewed as “an extension of the marketing arm of pharmaceutical companies,” or to be beacons of transparent data processes that inform clinicians, improve patient treatment, and provide high standards on which governments, health care providers and patients can have confidence.

Medical journals should demonstrate strong leadership by mandating open access to detailed clinical trial protocols and de-identified raw study data.  They should insist on independent audits of data, concomitant publication of an “accompanying abstract,” and lodgement of the data in independent databases; these three actions should be a precondition for publication.  (citations omitted)

Finally, in Science Translational Medicine, Learning from Hackers:  Open-Source Clinical Trials, by Adam Dunn, Richard Day, Kenneth Mandl and Enrico Coiera.  Behind a paywall, but here’s a news article in Australian Life Scientist and a post on Dunn’s blog.

See my previous posts on data sharing here and here.

More on the need for data sharing — the Tamiflu example

See my previous post on the need for data sharing.  For the past three years, a group of researchers has been trying to gather all of the clinical trial data for the anti-influenza drug Tamiflu (oseltamivir), without success.  As a result there is continuing uncertainty about the benefits — and harms — of the drug.  They tell their story in a New York Times op-ed and an article in PLoS Medicine.  Here is the summary from the PLoS Medicine article:

  • Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.
  • More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators.
  • Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers.
  • We propose clinical study reports become available to such scrutiny, and describe one manufacturer’s unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.

Also in PLoS Medicine, a response by a group of European drug regulators.  The regulators agree that that data secrecy is no longer acceptable but list some reasons for caution.

Peter Doshi and Tom Jefferson, “Drug Data Shouldn’t Be Secret,” New York Times, April 10, 2012.

Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201. doi:10.1371/journal.pmed.1001201

Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open Clinical Trial Data for All? A View from Regulators. PLoS Med 9(4): e1001202. doi:10.1371/journal.pmed.1001202

Here is a summary from Pharmalot.

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