Science and Technology CommitteeSupplementary written evidence submitted by the Association of the British Pharmaceutical Industry (ABPI)

I am writing to you to provide an update on ABPI’s evidence to the Committee’s inquiry into clinical trials, following the completion of our research into the extent to which pharmaceutical companies disclose the results of clinical trials they sponsor. ABPI is submitting this research for publication very shortly; however, in the meantime, we would like to share with the Committee the final results for new active substances approved in 2010 as well as the aggregate results for 2009–11 inclusive.

This update refers to the information in paragraphs 3.5 and 3.6 of our written evidence to the inquiry, which contained the preliminary results of the research. The preliminary aggregate results were also referred to during the oral evidence session on 22 April.

ABPI undertook its own research in order to ascertain the level of completeness of the evidence base for recently approved medicines, by checking the extent to which results were disclosed for company sponsored clinical trials in patients, irrespective of prevailing requirements.

Year

Trials registered and summary
results posted/published within
12 months (%)

Trials registered and summary
results posted/published (as of
31 January2013) (%)

2010

116 of 144 (81%)

182 of 195 (93%)

Aggregate (2009–2010–2011)

616 of 807 (76%)

781 of 882 (89%)

Please note that the final disclosure percentages have changed slightly compared to those in the evidence provided to the Committee following additional information received from companies regarding trial results that were publically available prior to 31 January 2013.

We would be very happy to discuss these results with the Committee in more detail if requested, and were pleased to have had the opportunity to submit evidence to this important inquiry.

June 2013

Prepared 16th September 2013