Innovations in Clinical Trial Registers
Innovations in Clinical Trial Registers
Sunday, 15 February 2015: 1:00 PM-2:30 PM
Room LL21A (San Jose Convention Center)
The amount of publicly available information from clinical trials is increasing rapidly and going to continue to increase. The new European Union Clinical Trials law will require all future drug trials to be registered on a public register and to report results. The recently launched AllTrials campaign, calling for all clinical trials to be registered and results reported, has prompted government bodies and research funders to implement measures to address this. Some pharmaceutical companies have committed to publishing individual patient data from past trials. Challenges are posed by greater clinical trial transparency and availability of information. Clinical trials are being registered on one (or more) of dozens of global registers. Trial data are held in company and institutional repositories. Documents relating to trials -- protocols, regulatory summaries of results, clinical study reports, consent forms, and patient information sheets -- are scattered in different places. It is difficult to track the information that is available, in order to audit for gaps in information and for doctors and regulators to be sure they have all the information they need to make decisions about medicines. There is an unprecedented opportunity to refine how clinical trial data are shared and linked. Experts in this session will discuss the strengths and weaknesses of current registers and new approaches being taken by industry and will introduce AllTrials.org, a new linked and indexed database of all clinical trial information.
Organizer:
Victoria Murphy, Sense About Science
Moderator:
Síle Lane, Sense About Science
Discussant:
Frank W. Rockhold, GlaxoSmithKline
Speakers: