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Sharing clinical trial data, in particular individual patient data, constitutes a major opportunity for new drug development and health care. The Institute of Medicine (IOM) recently released a report on the topic Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. DIA followed that release by gathering a panel of key opinion leaders in an online webinar to summarize and address many of the critical issues raised in the report. (Read the report online.)

Each speaker emphasized a different perspective. Dr. Joanne Waldstreicher, a member of the IOM panel and Chief Medical Officer, Johnson & Johnson, summarized the report’s key findings, and provided the point of view of someone engaged in commercial drug development. Dr. Deborah A. Zarin, the Director of ClinicalTrials.gov., addressed data sharing issues primarily at the study level, while Dr. Michael Pencina, Professor of Biostatistics and Bioinformatics at Duke University and Director of Biostatistics at Duke Clinical Research Institute, delivered reaction from the academic world. Zachary Hallinan, Director of Patient Communication and Engagement Programs at the Center for Information and Study on Clinical Research Participation (CISCRP), spoke on behalf of patients.

Clinical trials generate large amounts of data, the report states, though much of that data is never published or made available to other researchers. Other analyses have shown that unsuccessful clinical trials are far less likely to be published than successful studies. Accordingly, patient care and public health stand to benefit by increased access to these data, Dr. Waldstreicher said in summarizing some of the report’s key findings. Data sharing could benefit scientific discovery and create new ideas for drug medical research. It also would increase public trust in clinical trials. But data sharing entails risks, burdens, and challenges, including patient privacy, return on commercial investment, academic recognition, and confidence in the validity of the analyses.

The report recognizes that a change in the data sharing culture is necessary and that critical stakeholders can each contribute to creating this new culture.

Fundamental to any successful sharing effort will be a change in culture, Dr. Zarin asserted; however, many drug R&D organizations are not used to sharing clinical trial data. The IOM report succinctly lays out basic recommendations of what should be shared and when. While important work remains to be done with study-level data, more effort, including agreement upon disclosure policies, is also required with the release of individual patient data.

Dr. Zarin outlined a potential role for ClinicalTrials.gov in the process, as an anchor point in an initially uncharted sea of data and platform chaos. ClinicalTrials.gov also could provide a context for available information, including a listing of all trials on a topic and documentation on what information is available for each trial, helping to avoid disclosure bias. This report is the first source to suggest common ground rules for data sharing, Dr. Pencina indicated. The report also acknowledges the need of contributions from multiple stakeholders; defines data types to be shared at different times in the trial lifecycle, including trial results; and acknowledges the need for a policy to protect the validity of analyses.

However, it also presents challenges to making this data sharing work, including the lack of universal infrastructure standards; coordinating the data release timelines; and the costs of analyzing data and making it sharable. Preparing individual patient data for sharing adds to the cost of trials, he said; because academic investigators rely on external funding to support their research, he continued, we must develop funding mechanisms to encourage the use of shared data and for existing data analyses. The academics’ largest concern is ensuring the quality of the shared data and therefore guaranteeing the acceptable quality of research that relies on that shared data.

Patients overwhelmingly support greater data sharing and transparency, Hallinan noted. The benefits of data sharing include maximizing patient contributions, preventing unnecessary research, and hope for new and better medical research. He added that patient recruitment and retention for trials continues to be a struggle in part because “large percentages of patients and the public still mistrust clinical research.” He cited a 2013 CISCRP survey of Public and Patient Perception in which 28% of the 6,000 respondents said they don’t trust sponsors to inform the public quickly about safety concerns. Sharing trial data with patients will increase their trust in the process. He offered other recommendations to ensure that data sharing is well-received by patients and the public, including regularly benchmarking public and patient perceptions of the transparency process; agreeing on processes for engaging patients and patient representatives in all stages of the process; and always sharing findings with patients.

This article originally appeared in the August 2015 issue of the Global Forum - click here to read the entire issue.

To learn more, listen to the On-Demand Webinar: Expert Reactor Panel: IOM Report on Sharing Clinical Trial Data.