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The development of policies and guidelines for the sharing of research data is a popular topic at present.
In June 2013, the European Medicines Agency released a draft policy on publication and access to clinical-trial data for a three-month public consultation. More than 150 individuals and organisations submitted over 1,000 comments. The Agency is now considering all of the comments submitted in order to finalise the policy. An update on timelines will be provided at the latest following the EMA Management Board meeting on 11-12 December 2013. More details are available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000556.jsp.
At the US Institute of Medicine an IOM committee has been established to conduct a study to develop guiding principles and a framework for the responsible sharing of clinical trial data. The study will produce an interim and final report. The interim report will be released for public comment in January 2014 and will include tentative findings on (a) guiding principles that underpin responsible sharing of clinical trial data and (b) a characterization of a selected set of data and data sharing activities (to clarify definitions and develop a shared nomenclature). Based on public comment on the interim report and on further deliberations, the committee will prepare a final report with findings and recommendations on the benefits and risks of sharing and not sharing clinical trial data and on opportunities to enhance responsible sharing of clinical trial data. The anticipated release date for the final report is December 2014.
The UK’s Nuffield Council on Bioethics has convened a working party to look at ‘the collection, linking, use and exploitation of biological and health data: ethical issues’. Their open consultation is running from 17 October, 2013 to 10 January, 2014 and is available from https://www.nuffieldbioethics.org/topics/data-and-technology/biological-and-health-data. Questions asked in the consultation include:
Do biomedical data have special significance?What are the new privacy issucanes?What is the impact of developments in data science and information technology?What are the opportunities for, and the impacts of, the use of linked biomedical data in research?What are the opportunities for, and the impacts of, data linking in medical practice?What are the opportunities for, and the impacts of, using biomedical data outside biomedical research and health care?What legal and governance mechanisms might support the ethical linking of biomedical data?
Just want to add a few points from an investigator-initiated trial perspective. Investigator-led trials have substantial budget limitations and the work required to make shared data useable can be costly. Additionally, where investigator-initiated work runs counter to commercial interests there is a possibility of commercial interests, with the resources they have available, undertaking multiple additional analyses from raw data to find something that supports their commercial interests. Trial data should be analysed according to pre-specified statistical analysis plans and then published- release of raw data provides a potential pathway for invalid analyses to end up in marketing material without being subject to peer review.
Just to note data sharing was discussed at the FERCAP conference in Indonesia earlier this week. A couple of members of the panel from pharma mentioned that they were anticipating that data would be shared from industry sponsored trials within the next 2-3 months.
Really interesting to read the EMA draft document and the outline for the IOM document.
I would like to highlight the issue of data sharing in reverse e.g. the need for public health agencies to share their data collected during an outbreak with the clinical researchers particularly if a novel pathogen and all data is important to help define protocols etc.