Sea Change in Open Science and Data Sharing
Leadership by Industry
With remarkable speed, the landscape of open science and data sharing is changing. Fueled by recent evidence that the results of many clinical trials of interventions in common use are never published or reported and that these studies are not missing at random, a persuasive argument has been made that all data from human trials should be available to inform clinical practice.1–6 This would also promote higher quality and higher integrity science, although some urge caution as a result of concerns about unintended adverse consequences.7
In response to these calls for action, some companies have stepped forward and demonstrated leadership. GlaxoSmithKline, in coordination with other companies such as Roche and ViiV, committed early to data sharing.8 Medtronic contracted with our research team, the Yale University Open Data Access Project,9 to conduct external reviews of its clinical trial data for a single product. In addition, we developed policies and procedures to share these data with other investigators. Importantly, Medtronic fully transferred the decision-making authority on how to share the data and who could receive the data to the Yale University Open Data Access Project. Janssen, the pharmaceutical companies of Johnson & Johnson, has now contracted to do the same for the trials under its auspices. Increasingly, other companies are announcing their intention to share data from all published and unpublished clinical trials.
On July 24, 2013, the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America publicly announced the commitment of their member companies to share clinical trial data and results. Specifically, member companies would share patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union with qualified scientific and medical researchers on request and subject to terms necessary to protect patient privacy and confidential commercial information.10 In addition, synopses of clinical study reports for clinical trials in patients submitted to the United States Food and Drug Administration, European Medicines Agency, or national authorities of European Union member states will be made publicly available on the approval of a new medicine or new indication. Pharmaceutical Research and Manufacturers of America and European Federation of Pharmaceutical Industries and Associations set a date of January 1, 2014, by which these commitments would be implemented.
It is now an appropriate time to review what these companies have announced and the current mechanisms for data sharing. Industry is developing new models for sharing and setting the pace for others involved in the clinical research enterprise, including public and nonprofit trial funders. Tables 1 and 2 represent a summary of the current data-sharing policies of the top 12 pharmaceutical companies, based on market capitalization.11 This information was obtained from the companies’ public Web sites and organized according to key domains. The data-sharing models continue to evolve in concert with ongoing discussion about the role of funding, the use of trusted intermediaries, the measures needed to protect privacy, and the approaches that are most likely to promote the responsible conduct of research.
It is clear that a sea change in concept and action has occurred, at least in industry. Scientists now have access to data that required billions of dollars to produce. Furthermore, the actions of these pharmaceutical companies are honoring the good faith of subjects who participated in scientific research, providing more opportunity to learn from the data that were generated while taking measures to ensure that the privacy of trial subjects is fully respected.
There is much still to do, and the challenges are considerable. Data sharing allows for replication of results and extension of knowledge from investments in creating data resources. It promotes the engagement of scientists in public dialogue about clinical studies and their interpretation. It is an impediment to fraud and has the potential to expose poorly conducted studies, although it also introduces the potential for false claims and increased litigation resulting from the work of inadequately skilled scientists. In addition, there are the ever-present concerns surrounding violations of subject privacy or abrogation of the spirit of their informed consent. Other issues related to costs and who will bear them in the long-term are yet to be resolved. The goal of data release ought to be to enhance the likelihood of the benefits and minimize the possibility of the harms—and for the approach to be sustainable and the conditions favorable for attracting scientists to make use of the data. Such issues are being widely discussed in forums such as a focused workgroup of the Institute of Medicine that includes a broad range of stakeholders.33
Academia, outside of the basic sciences, remains far from a consensus on data sharing. Findings from many studies are never published or are published after long delays, including a high proportion of those funded by the National Institutes of Health.34,35 Trial results often go unreported on ClinicalTrials.gov.36 Although there are obstacles to be overcome in the academic environment, including funding, academic credit, and privacy issues, the current situation is untenable. It is time for academia to meet the standards that are being established by industry.
For now, scientists worldwide are encouraged to use these data that are being disseminated by industry–data that have the potential to be an unprecedented resource. These data are being made available to facilitate the development and testing of new hypotheses, to confirm or refute existing beliefs, and to advance knowledge in an effort to improve patient outcomes and public health. The success of data-sharing initiatives should be measured not by how many databases are made available but by how much useful knowledge is efficiently produced through their use and whether health and health care are improved as a result. The summary of policies presented here demonstrates that leaders in industry have overcome significant challenges to take the first critical steps toward changing the culture of science.
Sources of Funding
This work was supported by grant U01 HL105270-04 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute. Dr. Ross is supported by grants K08 AG032886 and K08 AG038336 from the National Institute on Aging and by the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program.
H.M. Krumholz, C.P. Gross, K.L. Blount, J.D. Ritchie, B. Hodshon, R. Lehman, and J.S. Ross disclose that they are recipients of research grants from Medtronic and Johnson & Johnson, through Yale University, to develop methods of clinical trial data sharing. H.M. Krumholz discloses that he chairs a cardiac scientific advisory board for UnitedHealth, and J.S. Ross discloses that he is a member of a scientific advisory board for FAIR Health.
The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
- © 2014 American Heart Association, Inc.
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