The movement towards open science is gathering pace, driven by scientific and ethical imperatives—not simply by the technological possibilities. In medicine such openness has real potential to benefit patients and society. Indeed, the arguments for open registration and publication of studies’ protocols, methods, and main results are underpinned by ethical arguments that are focused on patients and the public. The Ottawa Statement on trial registration is a prime example.
But truly open science means more than access to articles and to summaries of study designs and results, even when such open access comes with a licence that allows text mining and other forms of unrestricted reuse. Really meaningful reuse and further analysis of clinical studies depend on access to the anonymised patient-level data, along with the statistical code, details of any missing data, and other supporting information. This doesn’t necessarily have to be public access. There are good arguments in favour of either access with registration (for instance of personal details, proposals for further data analysis and reuse, and commitments to publish and share the new data), and for access on request (via an independent panel that considers proposals).
From a standing start, the race to share from clinical studies has really taken off. But, for those who’ve lost track, here’s the story so far—or at least the headlines, from a BMJ viewpoint:
Up to and including 2007
- 2003: US National Institutes of Health (NIH) publishes statement on data sharing.
- 2007: Annals of Internal Medicine launches policy on reproducible research and introduces data sharing statements for all papers.
- January: international funders’ joint statement.
- February: BMJ Open launches and is the first medical journal to integrate its submission process with the Dryad digital repository, so that data deposition is part of authors’ submission/workflow. Posts first linked dataset.
- January: BMJ publishes theme issue on hidden clinical trial data and some authors post datasets in Dryad digital repository.
- June: Royal Society publishes report on Science as an Open Enterprise.
- November: European Medicines Agency (EMA) commits to proactive publication of the data from clinical trials supporting the authorisation of medicines to enable the independent re-analysis of the evidence used by the Agency’s committees to determine their benefits and risks (from January 2014 onwards).
- December: Publication of SPIRIT statement on reporting protocols of clinical trials (Standard Protocol Items: Recommendations for Interventional Trials). SPIRIT checklist specifically asks, in items 31a and 31c, for plans on dissemination of results and data.
- Launch of AllTrials campaign and petitions, calling for all clinical trials to be registered and all results reported
- Launch of BMJ Open data campaign with podcast.
- The BMJ launches requirement that authors of drug and devices trials commit to sharing—on reasonable request—the anonymised patient level data for efficacy (main endpoints) and safety.
- UK House of Commons Health Committee says, in report on the National Institute for Health and Clinical Excellence (NICE), that the pharmaceutical industry should be obliged to release in a publicly accessible form all the information it possesses about trials of licensed drugs.
- JAMIA (journal of informatics in health and biomedicine) publishes theme issue on data sharing and privacy.
- BMJ Open publishes key paper on data sharing using clinical study reports (Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open 2013;3:3 e002496 doi:10.1136/bmjopen-2012-002496.).
- House of Commons Science and Technology Committee Inquiry on Access to Clinical Trial Data gathers written evidence.
- US Institute of Medicine publishes report of workshop: Sharing Clinical Trial Data. http://www.iom.edu/Reports/2013/Sharing-Clinical-Research-Data.aspx
- Evidence Live 2013 conference includes workshop and round table meeting.
- Association of the British Pharmaceutical Industry (ABPI) publishes report from technical workshop on Clinical Trial Reporting: definitions and guiding principles, including practicalities of data deposition.
- MEP Glenis Willmott, rapporteur for Environment, Public Health, Food Safety committee of European Parliament, holds open meeting about revising the EU Clinical Trial Directive, focusing on the likely impact on investigator-led academic trials if the Regulation (revised Directive) mandates data sharing in the form of Clinical Study Reports.
- Wellcome Trust holds workshop: Developing a strategy for clinical trial transparency—focusing on clinical trial data sharing. Wellcome Trust statement expected soon.
- UK Health Research Authority (HRA) holds meeting focusing on promoting good research conduct, including the publication of results and access to data and tissue.
- Nature Publishing Group (NPG) announces launch in Spring 2014 of Scientific Data, one of a new breed of data journals for articles describing datasets deposited elsewhere, including biomedical research data.
- European Medicines Agency (EMA) publishes final recommendations of five advisory groups on ethics, legal aspects, technical aspects, and logistics of sharing and analysing the data.
- European Medicines Agency (EMA) is ordered by the General Court of the European Union in an interim ruling not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court.
Coming up in 2013
- European Parliament: first reading and vote on proposed revision and amendments to Clinical Trials Directive/Regulation.
- EMA due to put its proposal on clinical trial data sharing out for consultation.
- European Parliament: second reading on proposed revision and amendments to Clinical Trials Directive/Regulation.
- EMA due to finalise data sharing policy.