Sharing Clinical Research Data Workshop Summary (2013) / Chapter Skim
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6 Changing the Culture of Research
6 Changing the Culture of Research
Pages 57-72
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From page 57... ...
Where journals can agree on principles and the means of en forcing those principles, they, too, can shape data-sharing policies. New policies at the European Medicines Agency on the re lease of clinical trials data could have implications for data sharing worldwide.
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From page 58... ...
THE ROLE OF REGULATORS Hans-Georg Eichler, senior medical officer at the European Medicines Agency (EMA) , which regulates drugs and biologicals in Europe, discussed recent major policy changes at EMA regarding sharing of data from clinical trials.
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From page 59... ...
Neither regulators nor industry like to be blindsided by reports that a drug or vaccine has an unreported side effect, but Eichler predicted that many licensed drugs could come under attack based on such reanalyses. As an example, he cited a meta-analysis of a drug called tiotropium bromide that found a slightly increased risk (relative risk of 1.6)
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From page 60... ...
THE ROLE OF JOURNALS Steven Goodman, who, in addition to his academic appointment at Stanford University School of Medicine is also associate editor at Annals of Internal Medicine and editor at Clinical Trials, discussed the role of journals in promoting data sharing and the challenges they face. In a paper published in Annals of Internal Medicine in 2007, Goodman and several colleagues announced a new policy the journal was adopting to require that manuscripts include a reproducible research statement (Laine et al., 2007a)
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From page 61... ...
has a very detailed requirement that funded researchers make any materials, data, databases, and software deemed integral to the publication freely and expeditiously available for use by other scientists, with no restrictions on use. Interestingly, HHMI actually specifies that researchers may not insist on collaboration, coauthorship, or prior review of manuscripts generated using their shared data and materials.
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From page 62... ...
Clinical trials can be extremely complex to organize and run, often requiring large collaborations, but secondary analyses of trials are "an incredibly important way for individual investigators to participate in the generation of new knowledge," said Briggs. For studies with budgets of less than $500,000, NIH policies are not clear regarding expectations for data sharing, Briggs acknowledged.
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From page 63... ...
suggested that a code of conduct governing the use of shared raw data could help to ensure that the original data collectors get fair credit for their work. He suggested that a code of conduct could include the following: an independent investigator planning to publish a new analysis of previously published data should contact the trialists, those who ran and published on the original clinical trial, before undertaking those analyses; if a reanalysis of the data is to be published, the trialists should be offered coauthorship or an opportunity to write a commentary to be published alongside the new analysis; journals should refuse to publish the new analysis unless this step has been taken; and finally, the original publication should be cited in any new analysis of the data.
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From page 64... ...
Trial Organizers as Collaborators on Secondary Analyses Myles Axton, editor of Nature Genetics, has been involved in several experiments to allow greater access to research data, including databases of genotypes and phenotypes, micro-attribution as a way to incentivize community annotation of the human genome, and peer review on an open data platform. However, at the workshop, he focused on a different means for ensuring that investigators get credit for data they generate.
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From page 65... ...
"We have to create a culture and a reality where people benefit as much from everyone sharing their data for all purposes as they currently do from protecting it." PROTECTING AGAINST MISUSE OF SHARED DATA One of the major barriers to data sharing identified by those in industry is fear over the misuse of data. Several workshop participants raised the possibility of controlled access as a means of protecting against the potential harms from poor-quality secondary analyses of shared data.
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From page 66... ...
It would be quicker than existing procedures and should work better because the trial group would remain involved in data reuse analyses and in publications. PATIENT-DRIVEN SHARING OF CLINICAL RESEARCH DATA Institutions that participate in the clinical research enterprise must comply with regulations such as the Health Insurance Portability and Accountability Act Privacy Rule and the Common Rule, which place clear boundaries on use of patient data.
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From page 67... ...
The purpose of this kind of framework is to create a system "that works without necessarily relying on the patient to evaluate and say yes to each and every research question that we want to bring to the data," said McGraw. The concept of data ownership is not very helpful in considering the sharing of health data, McGraw observed.
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From page 68... ...
Louis Children's Hospital and the Washington University School of Medicine, works with individuals who have Williams syndrome, a rare genetic condition affecting approximately 1 in 10,000 individuals. Kozel described health effects associated with Williams syndrome, including significant cardiovascular anomalies, hypertension, neurocognitive effects, predisposition for obesity and diabetes, and endocrine abnormalities.
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From page 69... ...
For example, the registry of the Williams Syndrome Association has an online forum where families can discuss changes in protocols and then make decisions about whether to continue with research. Social media and new technologies also could increase the engagement of patients and families, which could lead to better acquisition of data.
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From page 70... ...
New technologies, biomedical as well as ubiquitous sensors such as cell phones and computers, now enable people to collect longitudinal data on their health and other aspects of their lives, regardless of whether they are in a traditional clinical research study. A week before the workshop, Wilbanks got his genotype from the company 23andme and posted it on openSNP, which is a wiki based in Europe created by a postdoctoral fellow to enable genomics research.
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From page 71... ...
For example, he said, "50 people with early-onset Parkinson's could come in and say, ‘we've got genomics data, we've got all sorts of other omics data, we've got metabolic and molecular data, it's in a standard format -- $50,000 prize to the first person who builds a successful computational model.'" Wilbanks proposed a simple set of standards to guide this kind of public-driven data sharing. First, he said, be honest with people.
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