Clinical Study Reports – Unplugged
Tom Jefferson
Dear
friends,
Have you ever wondered how big a CSR is or what its structure is?
We have done a descriptive review of 78 Clinical Study Reports (CSRs) of 90 clinical trials of 14 different pharmaceuticals. All were from open sources, and covered therapeutic and biological interventions including antipsychotics, antidepressants, antivirals, natural antiarthritics, anti-inflammatory agents, pandemic influenza vaccines, statins, erythropoietins and antiplatelet compounds.
Although some of the CSRs are incomplete, the review shows just how complex and large CSRs are. We hope our work will inform the current debate on data access. Free full text here:
Doshi P, Jefferson T. Clinical study reports of randomised controlled trials:
an exploratory review of previously confidential industry reports. BMJ Open.
2013 Feb 26;3(2):e002496.
http://bmjopen.bmj.com/content/3/2/e002496.full and
http://dx.doi.org/10.1136/bmjopen-2012-002496
Regards,
Peter Doshi and Tom Jefferson.
ARTICLE FOCUS
- What are clinical study reports (CSRs)? What do they contain and how long are they?
- Can CSRs help address reporting biases associated with the published literature, and improve the quality of evidence synthesis?
KEY MESSAGES
- CSRs represent a hitherto hidden and untapped source of detailed randomised controlled trial data (mean page length: 1854 pages), increasingly becoming publicly available, and should form the basic unit for evidence synthesis to minimise the problem of reporting bias.
- CSRs show that numerous individuals make important technical contributions to the design, conduct and reporting of each trial, but journal publications often fail to record these details, resulting in a loss in individual responsibility for what is reported.
- The ICH E3 guideline to which most CSRs conform was published in 1995, and needs updating.
STRENGTHS AND LIMITATIONS OF THIS STUDY
- We cannot say whether our sample is representative and whether our conclusions are generalisable to an undefined and undefinable population of CSRs.
JIM MURRAY
the EP Rapporteur has proposed an amendment requiring submission of a
Clinical Study Report for each trial within one year, instead of the
(useless) "trial summary" proposed by the Commission. She will need
all the support she can get to get this through the Parliament,
Commission and Member states, given I assume fierce industry
opposition.
Jim Murray
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