Skip to main content

Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
Currently Skimming:

7 Challenges and Disincentives for Sharing and Reuse of Data
Pages 75-86

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 75...
... The third panel to consider key challenges to clinical trial data sharing and reuse examined challenges and disincentives. Matthew Sydes, pro 75
Read the entire page →
From page 76...
... RESEARCHER PERSPECTIVE Matthew Sydes, Professor of Clinical Trials and Methodology, Medical Research Council Clinical Trials Unit, University College London Sydes shared an observation from serving as chair of the Scientific Committee for the International Clinical Trials Methodology Conference (ICTMC) in Brighton, United Kingdom, in 2019.
Read the entire page →
From page 77...
... To help address this, Sydes offered several suggestions applicable to researchers requesting data for secondary analyses: • Data requesters could be required to define analyses in advance. Sydes said that guidance for developing statistical analysis plans for clinical trials could inform secondary analysis plans as well (e.g., Gamble et al., 2017)
Read the entire page →
From page 78...
... Sydes speculated that some of the applicants for data access are not actually interested in individual clinical trials (i.e., comparative data) but are instead seeking "prospectively collected, high-quality data." For example, they might be seeking data estimating event rates in a particular population, and a particular trial is a means to obtain a sample set.
Read the entire page →
From page 79...
... SOURCE: As presented by Matthew Sydes, November 18, 2019.
Read the entire page →
From page 80...
... Perhaps an "IMDb for clinical trials" could use digital object identifiers, ORCID IDs,3 or other unique identifiers to link researchers and d s ­ ata­ ets they have contributed to, and enable better recognition of these contributions, Sydes suggested. Such recognition could help to alleviate some of the concerns about data sharing.
Read the entire page →
From page 81...
... Drawing from his experience as a sponsor of clinical trials, Daron listed three elements of effective partnerships and alliances: 1. Ability to execute.
Read the entire page →
From page 82...
... Better internal sharing of trial data has also enabled new insights and enhanced the efficiency of translational research. Case Example: Learning from Failures Another example of the value of data sharing is the potential to gain new insights from failed clinical trials that did not meet predefined outcomes, Daron said.
Read the entire page →
From page 83...
... Ongoing discussions about value versus the risk/cost of clinical trial data sharing are primarily about the benefit/risk for researchers and study sponsors, she observed, and not about what is needed from a participant perspective. She suggested that institutions conducting trials often use issues such as participant privacy or the costs of data sharing as excuses for not sharing.
Read the entire page →
From page 84...
... She explained that the sponsor will add data to each participant record in real time, which means there is no lag time in the return of data to trial participants, and also facilitates use of data as they are generated. PEER also has a "virtual data analysis sandbox," which she explained allows researchers to conduct analyses on data in the platform, as well as securely upload their own analysis tools and proprietary datasets for use, and to share findings to the PEER participants' records.
Read the entire page →
From page 85...
... CHALLENGES AND DISINCENTIVES FOR SHARING AND REUSE OF DATA 85 Sydes raised the issue that consent for pediatric populations is given by parents or guardians, and technical re-consent is required when the child reaches legal age so the status could change. Sydes also reiterated the point from an earlier discussion that if data are not shared from the entire trial cohort, that can lead to bias in any subsequent analyses, including meta-analyses (i.e., the patients shared do not fully represent the trial data)
Read the entire page →

Key Terms

  • data sharing
  • clinical trial
  • clinical trials
  • data access
  • secondary research

  • effective partnerships
  • shared data
  • research advocacy
  • genetic alliance
  • advocacy organization

  • trials unit
  • analysis plans
  • peer participants
  • access requests
  • sharing data

  • reviewing data
  • genomic data
  • independent data
  • data architecture
  • data monitoring

  • collected data
  • academic clinical
  • clinical trialists
  • trial steering
  • trial investigators

  • disease advocacy
  • terry shared
  • sharon terry
  • enable access
  • institutions conducting


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.