The evidence base for current treatments has been built largely on aggregated results published in journal articles—articles that report trials initiated and sponsored by industry in order to get marketing approval for its products. At last we’re moving towards knowledge based on independent analyses of the original data about real participants in clinical trials, with great strides taken in the past year.
This movement is really gathering pace. The AllTrials campaign continues to grow, and was joined in February by GSK, which pledged to make all its Clinical Study Reports publicly available on its register and then in May opened its platform for controlled access to patient level data. And the UK Health Research Authority (HRA) announced its plans to make clinical trial registration a condition of a favourable ethics opinion through the National Research Ethics Service (NRES) and to ensure that participants’ consent to research is “not a later barrier to data sharing and future access to tissue.”
June’s also proved to be quite a month for data sharing advances. This week the European Medicines Agency released its draft policy on publication and access to clinical trial data for public consultation until 30 September. If implemented—and legal challenges are currently making that a big if—the policy will allow researchers access to patient level data to conduct and publish their own reanalyses and secondary analyses, a big step for transparency and truly evidence based medicine.
And in the past few days the Yale Open Data Access project (YODA) published three papers about their independent meta-analyses of patient level data provided by a company, Medtronic Inc. about its own product, recombinant human bone morphogenetic protein-2 (rhBMP-2). Two papers were in Annals of Internal Medicine, here and here, and one in the BMJ. Medtronic Inc. provided the YODA team with a grant for the studies and for future data sharing, and gave them full access to all its rhBMP-2 data. The meta-analyses were conducted independently by two academic groups convened via YODA.
One of the longest running data access projects is the joint campaign by the BMJ and the Cochrane Acute Respiratory Infections Group to investigate the effects and harms of neuraminidase inhibitors in preventing and treating influenza in healthy adults. This matters a lot, and not just from a clinical and public health standpoint: the World has spent a fortune on stockpiling drugs whose performance is still in doubt.
Roche promised in December 2009 to give the Cochrane investigators full access to all its clinical trial data on oseltamivir (Tamiflu) but has only just started to supply those data, in the form of partially redacted Clinical Study Reports. This data release is part of Roche’s wider policy on clinical data transparency, announced in February. Unlike GSK, Roche hasn’t signed up to AllTrials, isn’t making CSRs publicly available (the company will “provide any CSR on request that cannot be obtained from the EMA for third party researchers”), and hasn’t yet provided much detail of its data transparency programme.
The company has, however, given a grant to a group convened by four virologists to “review the oseltamivir data (both from randomized controlled trials and from observational trials, including data from the 2009/10 pandemic), to identify any data gaps and to develop an agreed analysis plan between MUGAS invited partners.” This MUltiparty Group for Advice on Science (MUGAS) met in Brussels on 18 June and agreed to scope out and conduct individual patient data meta-analyses on oseltamivir. I was there as a reporter and have blogged about the meeting.
The MUGAS initiative is a bit like the YODA project in principle—in that two different groups will be working in parallel to meta-analyse data from the same RCTs. But the work of only one of the groups, MUGAS, is being funded by the company that makes the product in question. And, in practice, will the Cochrane group really have access to the same data as the MUGAS group?
Back in March at EvidenceLive2013 Jack Cuzick, Professor of Epidemiology at the Wolfson Institute of Preventive Medicine, London, asked a hall full of methodologists and Cochrane Collaboration fans whether systematic reviews should be done only by people with appropriate clinical expertise. “Blind following of prespecified rules has led to reviews which defy common sense” argued Prof Cuzick. Handbooks and reporting checklists are no replacement, he said, for a good understanding of the subject matter and judgment about the quality of the primary studies. The MUGAS virologists certainly know their subject and should know a lot about the quality of the primary Roche studies—they coauthored many of them.
Trish Groves, deputy editor, BMJ.
Trish is on Twitter @trished