Regulatory Data and its Role in Assessing Treatment Effects

Clinical Study Reports (CSRs) are often created as part of the process of submitting applications for new medical treatments to regulators. They are typically very long and, typically, very long, providing much more detail about the methods and the results of a trial.

Several regulators make CSRs publicly available after a drug or vaccine has been approved, improving transparency in the decision-making process.

Studies we discussed

• Clinical trials and drug promotion: Selective reporting of study 329. International Journal of Risk and Safety in Medicine, vol. 20, no. 1-2, pp. 73-81, 2008

• No correction, retraction, apology, or comment: The paroxetine trial reanalysis raises questions about institutional responsibility. BMJ 2015; 351: h4629 doi: 10.1136/bmj.h4630

• Ensuring safe and effective drugs: who can do what it takes? BMJ 2011; 342 :c7258 doi:10.1136/bmj.c7259.

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