Sharing Clinical Research Data Workshop Summary (2013) / Chapter Skim
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7 Final Reflections on Sharing Clinical Research Data
7 Final Reflections on Sharing Clinical Research Data
Pages 73-80
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From page 73... ...
Although notable progress has been made in sharing of pla cebo and comparator arm data, companies need to think about the boundaries of precompetitive space and what is gained and risked by sharing active arm data. Given their access to valuable data and their urgency to ad vance treatment alternatives, patients need to be engaged as partners in the clinical research process.
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From page 74... ...
These reports, which generally contain the methodology, the subgroup analyses, the sensitivity analyses, and other detailed analyses of the data, are "low-hanging fruit" that could add to the information available in publications, without engendering the kinds of concerns raised when sharing patient-level data, said Jesse Berlin, Janssen Research & Development. Peter Doshi, Johns Hopkins School of Medicine, agreed that clinical study reports may be good initial targets for data sharing because they already exist for nearly all trials.
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From page 75... ...
For example, partial release of data where trial organizers are allowed to decide which information to publicize creates the potential for selection bias. THE BOUNDARIES OF PRECOMPETITIVE COLLABORATION Many of the data-sharing initiatives discussed during the workshop, such as the Datasphere Project, the Coalition Against Major Diseases and ePlacebo, involve the pooling of data from placebo or comparator arms of trials.
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From page 76... ...
During the closing discussion period and throughout the workshop, many participants talked about forming stronger partnerships with patients as a priority action for advancing clinical research. There was also discussion on how best to give back to patients who donate their time and personal information, and willingly take on the risks associated with novel treatments and protocols.
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From page 77... ...
Information about potential improvements in treatments will create incentives to participate for both patients and physicians, as will transparency on what happens with the data and assurances that patients participating in research will be the first to benefit from resulting treatment advances. Patients' data could be available online, which will "unleash an ecosystem of third-party applications," according to Tenenbaum, offering value "that we can't even anticipate but that will have a dramatic impact on health." Janet Woodcock, CDER, agreed with Tenenbaum that the Internet and social media could be used to learn much more about patient populations and the natural history of diseases, particularly those that are rare and therefore difficult to study.
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From page 78... ...
But making sure that a participant can put his or her individual assignment in the context of the results of a trial will take time and effort. The Need for Leadership Sharon Terry, president and chief executive officer of Genetic Alliance, concluded the workshop by observing that far too few people are participating in clinical research.
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From page 79... ...
What is needed, she concluded, is leadership from each of the stakeholders involved in clinical research. Each group needs to ask how it is impeding the flow of information and the conduct of research and take steps to remove those barriers.
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