The AllTrials campaign (explained in a recent interview in our online magazine Biome) and books such as Ben Goldacre’s Bad Pharma have brought the issue of registration and reporting of clinical trials into the spotlight. The push for greater transparency continues to gain momentum. Recent discussions around the European Medicines Agency’s (EMA) proposal to proactively publish the information submitted to them as part of the standard marketing-authorisation application process has further brought the issue to the forefront. This data submitted to the EMA would be made available for independent reanalysis, after the EMA have completed their decision making process on the application.
Recently, BioMed Central attended a panel discussion organised by Oxbridge Biotech Roundtable (OBR) in which panellists, drawn from both academia and industry, discussed registration and reporting of clinical trial results as well as the complicated issue of access to individual participant level data. The panel was moderated by Andrew Jack, Pharmaceuticals Correspondent for the Financial Times.
Discussions kicked-off with a question on how serious a problem there is with the current level of clinical trial reporting. David Tovey, Deputy CEO and Editor-In-Chief of the Cochrane Library, feels there is a big problem, and it directly affects patient care. He explained that, since we quantify benefits and harms of specific treatments based on evidence, the absence of full access to the data skews clinical decision making. Systematic reviews, regarded as the highest level of evidence for medical interventions, are undermined when there isn’t full disclosure or data is incompletely reported. Bina Rawal, Director of Medical, Innovation and Research at the Association of the British Pharmaceutical Industry, thinks the situation is improving and that lessons have been learned; though, Tovey warned that we should not just look prospectively – a patient visiting their doctor today will be prescribed drugs that are available today, not those that may be available in the future. Mahdi Farhan, Group Clinical Director, Roche Products Ltd, added that there are missed opportunities within the pharmaceutical industry to share data with clinicians, researchers and other members of industry.
Panellists were asked whether academics and non-profit organisations should be held to the same level of disclosure as industry and all agreed they should. Deborah Ashby, Professor of Medical Statistics and Clinical Trials and co-Director of Imperial Clinical Trials Unit explained that the problem is not limited to clinical trials or to industry. To her, the principles are clear: “all trials, all data should be out there. We owe that to patients who took part; we owe that to future patients”, but she added that “the devil is in the detail” explaining that there are complex practical issues around responsibility for data from historical trials, infrastructure, and confidentiality with patient data.
Access to individual patient data is a notoriously tricky issue and discussions moved to who should have access. Panellists were divided on the need for ‘gatekeepers’ vs data being openly accessible. Rawal believes that responsible data sharing involves evaluating the request and the requester and that this is a particular issue with small data sets and rare diseases. Ashby welcomes different people doing different analyses, but cautioned that a delicate balance must be struck between the risk of re-identification from de-identified datasets and the limitations of completely anonymized data sets.
It is clear that the issue of registration and reporting of clinical trials will continue to be important. We all play a role in increasing transparency in clinical trials, and must work together to ensure that clinical decisions are made on all of the data. BioMed Central will continue to support efforts to increase transparency, for example through our policy to require registration of all clinical trials, the ISRCTN registry service, and publication of negative results and unfinished studies.