Eli Lilly has become the latest pharma company to provide data from clinical trials to a portal that provides anonymised patient-level data on request to qualified researchers.
The initiative – at clinicalstudydatarequest.com – spearheaded by GlaxoSmithKline last year and expanded with the involvement other pharma companies including Boehringer Ingelheim, Novartis, Roche and ViiV Healthcare, which started uploading trial data to the site earlier this year.
Lilly said it has started sharing data on approved medicines with the portal to “increase access to and transparency of clinical trial results with researchers around the world,” and says it will phase out its existing site at lillyclinicalstudydata.com.
The company has said will include phase II to IV clinical studies submitted as part of regulatory dossiers for medicines and indications in the US and EU dating back to 1999, a similar pledge to that voiced by Boehringer in April at the company’s annual conference.
At the time, the decision to include historical studies was welcomed by clinical trial transparency group AllTrials, with co-founder Ben Goldacre saying: “These are the trials that matter the most, as they are the ones conducted on the treatments in use today.”
The commitment showed that the “tide is turning” on transparency, he added.
Lilly has also said it will include phase II to IV global studies with a first patient visit after January 1, 2007, as well as phase II to IV global or regional/local studies in indications approved in both the US and EU with a first patient visit after January 1, 2014.
That still falls short of what some transparency campaigners want, which is for all clinical trials to be registered and all results reported.
“By joining others in our industry to share clinical trial data with qualified researchers, we can quicken the pace of scientific advances needed to make life better,” commented Lilly’s chief medical officer Tim Garnett.
The platform ties in with ongoing efforts by trade bodies European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), which have bother updated their data-sharing policies in light of the shift towards greater transparency.
Meanwhile, politicians in the EU are working on new legislation on clinical trial transparency that was backed by the European Parliament recently and is due to come into effect in 2016, while the European Medicines Agency is working on updating a draft policy first unveiled last year.
Alltrials backed the EMA’s initial proposals but said last week it was concerned that an updated draft may be backtracking by introducing barriers for researchers who want to scrutinise clinical study reports (CSRs), including “allowing access to CSRs on screen only and allowing trial sponsors to decide what information to redact.”