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Sharing Clinical Research Data Workshop Summary (2013) / Chapter Skim
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2 The Benefits of Data Sharing
Pages 9-18

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From page 9...
...  The practical and scientific arguments for data sharing include improving the accuracy of research, informing risk/benefit analy sis of treatment options, strengthening collaborations, accelerat ing biomedical research, and restoring trust in the clinical research enterprise.  A cultural shift has already begun as leaders in industry, aca demia, and regulatory agencies recognize the value in increased transparency and data sharing and are focusing on how -- instead of why -- data should be shared.
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From page 10...
... Sometimes in the process of data entry, additional queries about the data are gen erated that must be addressed by the original investigator and the study staff. The term "participant-level data" generally refers to the de identified records of individual patients generated through this pro cess.
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From page 11...
... Data Sharing to Enable Independent Reanalysis Steven Goodman, associate dean for clinical and translational research and professor of medicine and health policy and research at the Stanford University School of Medicine, discussed the former use case in the context of ensuring that a study was correctly analyzed and interpreted. Independent reanalysis of data is the basis of reproducible research and can be an extremely difficult task.
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From page 12...
... The authors, therefore, argue that datasets and software should be made available to allow other researchers to conduct their own analyses and verify the published results. Peter Doshi, a postdoctoral fellow at the Johns Hopkins University School of Medicine, also discussed the application of shared data to credible assessment of clinical trial results.
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From page 13...
... These include detecting and deterring selective or inaccurate reporting of research; enabling the replication of results and potential resolution of apparently conflicting results; informing risk/benefit analyses for treatment options; facilitating application of previously generated data to new study questions; accelerating research; enhancing collaboration; and building trust in the clinical research enterprise. Rob Califf, director of the Duke Translational Medicine Institute, professor of medicine, and vice chancellor for clinical and translational research at Duke University Medical Center, who also spoke during the first session, pointed to the need to resolve results that appear conflicting.
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From page 14...
... Loder also called attention to the need to build trust in the clinical research enterprise. This trust is at "an all-time low," she said, which is causing a crisis in recruitment for clinical trials (Williams et al., 2008)
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From page 15...
... "We are engaged in one of the great struggles of human knowledge -- the struggle to liberate clinical trial information and make sure it is put to its best and highest use now and in the future," Loder concluded. "It is a thrill to be part of this historic meeting." Commitment to Open Science Every day, many people face difficult questions about health care, observed Harlan Krumholz, Harold H
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From page 16...
... Academic researchers could get credit not only for the papers they publish, but for the knowledge generated from the databases they create. Industry has the opportunity to demonstrate leadership, restore trust, and reclaim its position of integrity through meaningful actions to share data, Krumholz continued.
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From page 17...
... You can actually get wrong answers." Although there is a common belief that participant-level data can enable verification and reproduction of trial results, that premise is reliant on the trustworthiness of the shared data, warned Peter Doshi. Even participant-level data can lead investigators astray.
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Key Terms

  • clinical trials
  • clinical trial
  • adverse events
  • report forms
  • shared data

  • clinical practice
  • multiple trials
  • trial results
  • patient data
  • translational research

  • duke translational
  • research participants
  • translational medicine
  • rob califf
  • peter doshi

  • practice guidelines
  • category consists
  • independent reanalysis
  • vice chancellor
  • elizabeth loder

  • scientific arguments
  • medicine institute
  • clinical data
  • sharing data
  • data based

  • dividual clinical
  • support data
  • consider data
  • aggregate data
  • considered clinical


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