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The RIAT Act

Posted by poser938 on July 8, 2013, at 17:02:34

http://www.bmj.com/content/346/bmj.f2865

Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond

Well designed and well performed randomised controlled trials are considered to provide the most reliable evidence on the effects of health related interventions. However, the credibility of findings from individual trials and from summaries of trials examining a similar research question (that is, systematic reviews and meta-analyses) has been undermined by numerous reporting biases in the published medical literature. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Reporting biases are often difficult to detect, but have the potential to discredit earnest efforts towards evidence based decision making.

Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. 10 15 The first is no representation (invisibility), which occurs when a trial remains unpublished years after completion. The second is distorted representation (distortion), which occurs when publications in medical journals present a biased or misleading description of the design, conduct, or results of a trial. 1 6 10 14 Both go against the fundamental scientific and ethical responsibility that all research on humans be used to advance knowledge and are symptomatic of a general culture of data secrecy. The end result is that the healthcare, biomedical research, and policy communities may, despite best intentions and best practices, end up drawing scientifically invalid conclusions based on only those parts of the evidence base they can see.

A call to publishor be published

Despite near universal agreement that reporting biases are harmful, efforts to correct the problem have largely focused on forward looking initiatives. Prospective registration of trials has made major strides in ensuring that the biomedical community is aware of trials at their inception, but at best only around half of registered trials on ClinicalTrials.gov were registered before they began enrolling patients. 16 Recent studies have also shown that even when disclosure of study findings is mandated by law, results often remain invisible. 17 18 19 In addition, trial registration does not address the problems of invisibility and distortion for trials that took place before registers were widely used. Most importantly, those demanding correcting action lacked the data required to actually correct the scientific record. However, with increasing amounts of data entering the public domain, it is now becoming possible to move from words to action and publish (or republish) abandoned trials.

We have access to around 178 000 pages of previously confidential company research documents (table 1⇓, box). For drugs such as paroxetine, quetiapine, and gabapentin, litigation over illegal off-label marketing put thousands of pages of trial reports in the public domain. Other trial reports, such as for oseltamivir and clopidogrel, were obtained through new freedom of information policies at the European Medicines Agency (EMA) that have revolutionised the publics ability to access trial data. 20 21 22 23 The documents are a substantial resource of information about trials. We expect that other independent groups will also have access to many additional trial reports.

The documents we have obtained include trial reports for studies that remain unpublished years after completion (such as Roches study M76001, the largest treatment trial of oseltamivir, and Pfizers study A945-1008, the largest trial of gabapentin for painful diabetic neuropathy). We also have thousands of pages of clinical study reports associated with trials that have been published in scientific journals but shown to contain inaccuracies, such as Roches oseltamivir study WV15671, GlaxoSmithKlines paroxetine study 329, and Pfizers gabapentin study 945-291. 3 12 24 25 We consider these to be examples of abandoned trials: either unpublished trials for which sponsors are no longer actively working to publish or published trials that are documented as misreported but for which authors do not correct the record using established means such as a correction or retraction (which is an abandonment of responsibility) (box 1). 25 Because abandonment can lead to false conclusions about effectiveness and safety, we believe that it should be tackled through independent publication and republication of trials.


There is much more to read in the link at the top of the page.


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poster:poser938 thread:1046800
URL: http://www.dr-bob.org/babble/20130706/msgs/1046800.html