Late last year, we reported that GlaxoSmithKline promised to make detailed data from its clinical trials available to independent researchers so that scientists can draw their own conclusions about the safety and effectiveness of its new drugs,” reported Forbes.
Making a similar announcement, GSK recently announced “that in response to a new clinical trials data transparency initiative, it will commit to make all clinical study reports (CSRs) publicly available through its proprietary clinical trials register,” reported RAPS.
CSRs contain information about the trial’s design, methods and results—what GSK called the “basis of submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies.”
As reported by Regulatory Focus in January 2013, a new collaboration has sprung up in the hopes of pressuring companies and legislators to open up their clinical trials data to the public. That initiative, known as the AllTrials initiative, is being backed by a number of prominent voices, including academic and author Ben Goldacre, the British Medical Journal (BMJ) and the Cochrane Library.”
The AllTrials campaign calls for registering clinical trials, disclosing trial results and clinical study reports. The notion was recently endorsed by the lead legislator Environment, Public Health and Food Safety Committee in the European Parliament, who wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities.
“All involved parties need to work to ensure that all results of all clinical trials—past and future—on all treatments in current use are available to doctors and patients, so that they can make informed decisions about treatments,” the group wrote in a research piece posted on its website. The group’s petition has already garnered more than 23,000 signatures as of the time of this article's publication.
GSK acknowledged the initiative in its 5 February 2013 statement on its website, saying its own actions “further demonstrated its commitment to clinical trial transparency by announcing its support for the AllTrials campaign.”
The company further noted that since its October 2012 announcement, it has made 5,000 of its CSRs available online, which it said are accessed by more than 11,000 visitors each month.
Going forward, GSK said all CSRs will be published once a medicine has been approved or discontinued from development and the results have been published. “This is to allow for the data to be first reviewed by regulators and the scientific community,” GSK explained. "Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.”
Notably, the company also said it would seek to publish all CSRs for trials dating back to the company's founding—an undertaking the company said may be accompanied by "practical challenges," including the difficulty of removing identifying patient data from a massive volume of trials.
That move was surprising to some industry watchers, including Paul Ivsin of the industry blog Placebo Control, who called it a "major surprise." “That wasn’t going to be required by any law anytime soon”" Ivsin said in an email to Regulatory Focus. “The move seems to be a genuine over-and-above effort by GSK for which they'll deserve a ton of credit when they start doing it.”
Ivsin added that he felt the new announcement was less substantial in importance than the company's October 2012 announcement, but said it nevertheless adds to a sense that full CSR publications seem “inevitable.”
EMA is already moving in this direction, and FDA will follow suit either through pressure or (most likely) through new legislation,” he said. “GSK may have accelerated that process by 2 or 3 years. That’s not earth-shattering, but it’s good and important, and entirely refreshing to see a company in industry showing some actual leadership.”
Patrick Vallance, President, Pharmaceuticals R&D, GlaxoSmithKline, said: “We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research. All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”
Interestingly, GSK’s position and announcement put them somewhat adversely with the Pharmaceutical Research and Manufacturers of America (PhRMA). In their statement, PhRMA asserted that “The demands by Dr. Goldacre and the British Medical Journal to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials. It would also encourage second-guessing of the regulatory approval process, which would be disastrous for patients.”
“Dr. Goldacre often cites a January 2013 study published in the British Medical Journal that purported to evaluate whether trial results were present on ClinicalTrials.gov for records that the authors deemed to require results reporting under FDAAA. The authors claimed that only 22% of these trials had reported results within one year of completion of the trial. However, a preliminary analysis by the FDA presented at The Thirteenth Annual Pharmaceutical Regulatory and Compliance Congress in November 2012found that the BMJ study did not account accurately for all elements of the statutory definition for “applicable clinical trials,” that should be posted, PhRMA wrote.
“The FDA analysis of posted clinical trial data from May 2012 appears to contradict the BMJ study. FDA found that the vast majority (78%) of trials that met the criteria for required reporting were posted on ClinicalTrials.gov and only a low number appeared to be missing. 31% of trials that the BMJ study included as “missing” were classified by the FDA as not required to be submitted. While 21% of trials not reported is significant and the causes of underreporting must be studied and remedied, the BMJ study dramatically overstates the problem and does not reflect the full scale of clinical trial data sharing. Biopharmaceutical companies welcome an informed discussion of possible noncompliance in the reporting system with FDA, NIH and other stakeholders,” PhRMA added.
The Association for British Pharmaceutical Industry (ABPI) trade group was similarly adverse to GSK and Goldacre’s calls for releasing patient-level data. While they are in favour of sharing CSRs, they noted that it needs to be done in “a way that is responsible, reliable and reproducible across the world since clinical research is a global activity.”
In principle, they agreed that the information should be publicly available, but ABPI said there needs to “be a process involving the company in identifying what elements should not be disclosed due to data privacy concerns or to protect commercially confidential information.” “Our industry would urge civil society to prioritise what studies are most important to release. It is simply impossible for regulators and companies to release all study reports at once. Companies would rather spend time developing new medicines than going through millions of pages of historic data. Also, there must be a process of co-ordinating this process among the regulatory agencies - the same study reports have been submitted to agencies all around the world.”