News

Drug industry pledge on access to trial data is met with scepticism

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4829 (Published 30 July 2013) Cite this as: BMJ 2013;347:f4829
  1. Adrian O’Dowd
  1. 1London

Promises of far greater transparency and access to clinical trial data set out in new drug industry-wide principles have been met with scepticism by clinicians and researchers.

Two of the largest trade bodies representing the pharmaceutical industry—the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA)—published joint principles for responsible clinical trial data sharing on 18 July.1

The European federation collectively speaks for 1900 companies, while the US association has 32 member organisations.

The principles, which come into effect from next January, promise that biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.

The principles have been agreed to by all of the two associations’ member organisations.

They say that all drug companies will set up independent “scientific review boards” (made up of scientists and healthcare professionals not employed by the companies) to review requests from researchers for access to clinical trial protocols, patient level clinical trial data and study level clinical trial data.

Information will then be shared with “qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information.”

In addition, drug companies will make publicly …

View Full Text

Sign in

Log in through your institution

Free trial

Register for a free trial to thebmj.com to receive unlimited access to all content on thebmj.com for 14 days.
Sign up for a free trial

Subscribe