Data sharing in clinical research: challenges and open opportunities | EveryONE

"During our follow up it became clear that there is little consensus of opinion on the sharing of this particular dataset. Experts from the Data Advisory Board whom we consulted expressed different views on the stringency of the journal reaction. Overall they agreed on the need to consider the risk to confidentiality of the trial participants and on the relevance of developing mechanisms for consideration of data requests by an independent body or committee. Interestingly, the ruling of the FOI Tribunal also indicated that the vote did not reflect a consensus among all committee members.

 What lies at the heart of the complexity of this case, and the question of data availability for clinical data in general, is the tension between encouraging open science and the duty to protect those who generously contribute towards public benefit by participating in clinical research. There is a need for mechanisms and policies to address the different challenges related to confidentiality and these will require input from all stakeholders to maximize responsible data sharing and reuse.

 Funding agencies and institutions can support the development of scalable infrastructure that allows long-term preservation and access to datasets, as well as education and training among researchers to encourage data management plans as one of the steps in the research process. The availability of dedicated committees and services within institutions to evaluate data access requests and provide advice on ethical and legal considerations related to data deposition and access would also support greater data availability, while allowing more consistency in considerations over clinical data.

 There is also a need to adequately recognize those researchers who take steps to make their data available and reusable. Publishers can and should support that authors get credit for sharing their data, for example via the development of policies and the implementation of technological infrastructures towards machine-readable data citations.

 Our Advisory Board noted the need for trialists to consider amendments to consent procedures to cover the eventuality of data being shared. This is also referred to in ICMJE’s proposal [6] for the sharing of clinical trial data, which proposes to require that authors of clinical trials share de-identified individual-patient data (those underlying the results presented in the article) no later than six months after publication. The proposal received a large number of responses and mixed critiques, with some supporting the request for data to be shared while others raising concerns over risks of de-identification or inappropriate re-analyses unless sufficient information was provided with the datasets, as well as the costs involved in the process of anonymizing and preparing datasets for deposition."