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The ethical case for opening up drug trials

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I’ve written a few times about the crucial importance of documenting our failures when it comes to innovation.  This is particularly important in medicine as documenting ones failures can stop others going down similar blind alleys.

This has heralded the launch of open notebook science, whereby all aspects of research are made open and public so that both successes and failures are viewable.

A recent study, published in the British Medical Journal, explores the ethics of the issue, and whether researchers have an ethical imperative to share failed research with the world.

The study highlights how just 10 percent of drugs that enter the human phase of clinical testing ever make it to the market, with the majority of this learning and knowledge lost to the wider research community.

“We focused on drug trials in these three areas because they are a major focus for drug development,” the authors write.

“We expected to see that many of these trials are never published. What surprised us was the magnitude of the data withholding.”

The study explored data from trials conducted between 2005 and 2009, and found that just 37 percent of trials for drugs that didn’t make it to market were ever published.  This contrasts with 75 percent of trials for successful drugs.

Why sharing is important

The authors go on to reveal four main reasons why sharing information about these failed trials is so important, both for the research community and for patients.

  1. It allows researchers to better understand what doesn’t work, thus enabling them to adjust things accordingly, as when Viagra was adapted from an angina treatment to one for erectile dysfunction.
  2. Being more open also provides much richer safety information for other approved drugs.  The authors found that trials of experimental drugs often generated useful information for the safety of approved drugs, especially if they contained similar chemistry.
  3. Provides extra information about any limits that exist in animal models and other experimental techniques.
  4. Provides additional safety and efficacy information that could be crucial in other parts of the world.  What may be regarded as unsafe or ineffective in one part of the world may well be approved somewhere else.

“The failure of the drug developers to share their findings runs contrary to the Declaration of Helsinki, which lays out clear ethical guidelines for medical research involving human subjects,” the authors say.

“In our study, we found that over 20,000 patients were involved in ‘stalled’ drug trials that were never reported. That’s a lot of people whose altruism is not being honored.”

As with the open notebook movement, the appreciation of the importance of more transparent knowledge sharing is increasingly gaining wider acceptance.

The European Parliament, for instance, recently passed legislation that requires reporting of stalled trials.  The US is also considering similar policies to increase transparency in the process.

“Policies like these are no substitute for full publication, but they go a long way to redeeming the sacrifices of the research subjects and advancing the cause of more effective healthcare and better drug development,” the authors say.

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