Bumps and bridges on the road to responsible sharing of clinical trial data

Abstract

a Background Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. Purpose In this article, we offer some practical recommendations that will allow researchers to readily combine datasets from different studies and sources, thereby enabling meta-analyses that could have significant impact on advancing medicine. Methods The authors relied on their collective experience in the conduct and reporting of clinical trials to define the areas of potential concern related to responsible sharing of clinical trial data. We conducted a review of the literature and engaged in an iterative consensus-building process. Results To further the goal of responsible sharing of clinical trial data, collaboration on a consistent set of data standards and methods across both industry and academia is sorely needed. Protection of participant privacy is a paramount principle. The additional questions of who maintains, funds, and oversees databases of participantlevel data will be important to resolve. Requiring researchers to register their requests for participant-level data and to provide details of their intended research would allow others to evaluate the proposed research plan, consistent with the principles of science and transparency. Limitations The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

“…32,33 Chief among these are concerns about potential harm to research participants. 17,32,34,35 Sponsors and investigators express worries that participants’ privacy cannot be adequately protected, particularly in light of the fact that experts have demonstrated that it is possible to reidentify participant-level data. 35–39 Some pharmaceutical company representatives warn that the threat to privacy posed by data sharing will chill willingness to participate in trials, thereby delaying the availability of new therapies.…”

The need for even further progress with clinical trial data sharing efforts: patients are waiting

“…Sharing clinical trial data has the potential to improve public health by providing a better understanding of physiology and pathophysiology, as well as both the benefits and risks of all types of treatments, including medicines and devices. Importantly, it also enables a powerful approach to address important questions that could not be addressed within individual studies by using either a combined analysis or metaanalysis, enabling a far deeper understanding of diseases, subgroups of patients who might respond differently and strengthening the evidence base for future studies, treatment guidelines, r egulatory, payer and medical decisions [2].…”

“…Having acknowledged the progress made by the industry, the paper went on to state that overall, insufficient progress has been made by all research producers. We believe that all clinical trial sponsors should develop processes for responsible sharing of participant level data, to maximize the scientific and medical value of our collective clinical trial efforts [2]. The Pharmaceutical Research and Manufacturers of America, the European Federation of Pharmaceutical Industries and Associations, and the Biotechnology Industry Organization have all publicly announced principles that support sharing of clinical trial data (Biotechnology Industry Organization, 2014; Pharmaceutical Research and Manufacturers of America, 2013) [3].…”

To share or not to share? Expected pros and cons of data sharing in radiological research

“…To make datasets from medical research publicly available in a timely fashion requires regulations that maximize the benefits and minimize the risks [52,53]. Indeed, data sharing provides a potential for stimulating new ideas, avoiding duplication of trials, and enhance transparency [36,[54][55][56][57] as well as increasing collaboration and interdisciplinary research [1,58,59]. However, at the same time, sharing clinical data presents some risks, burdens and challenges such as the need to preserve the privacy of patients, to defend the legitimate economic interests of the sponsors, and to guard against invalid secondary analyses potentially undermining trust in clinical trials or otherwise harming public health [36,37,53,60].…”