Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
Currently Skimming:
8 Finding Value in Sharing Clinical Trial Data: Overcoming Usability and Sustainability Challenges
8 Finding Value in Sharing Clinical Trial Data: Overcoming Usability and Sustainability Challenges
Pages 87-100
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 87... ...
(Kush) • Technical barriers to data sharing can be overcome with stan dards and harmonized common data models; however, cul tural, political, and legal barriers can persist.
|
From page 88... ...
Monica Bertagnolli, professor of surgery at the Harvard Medical School, provided the perspective of an institution that generates and shares data. Rebecca Kush, chief scientific officer at Elligo Health Research, discussed next steps from a platform perspective.
|
From page 89... ...
Engaging research participants in decisions about how their data will be shared and used fosters trust in the biomedical research enterprise, Sim said. Maintaining patient trust is essential because without participants, there can be no clinical trials.
|
From page 90... ...
Technical issues raised by speakers throughout the workshop included IPD availability and the lack of any centralized, searchable catalog of IPD; insufficient data standardization; and inability to merge data. In addition, Helfand said that "users can't learn everything," elaborating that, for researchers whose primary background is in systematic review and meta-analysis, navigating original clinical trial data can be challenging.
|
From page 91... ...
He recommended that the training pathway for data analysts include trial experience. Helfand also agreed with the suggestions made regarding prioritizing which clinical trial data to share.
|
From page 92... ...
Biospecimens linked to Alliance clinical trials are contributed to NCTN Navigator, and genomic data are contributed to the database of Genotypes and Phenotypes. All other data requests are handled by Alliance, and Bertagnolli noted that Alliance receives many requests for legacy data.
|
From page 93... ...
Data sharing is, and always has been, a core value of Alliance. Bertagnolli said that Alliance has a "responsibility to clinical trials participants to share data in ways that bring the most benefit to society." Data sharing is also frequently a condition of funding awards, she said, and awards can include support for data-sharing activities.
|
From page 94... ...
PLATFORM PERSPECTIVE Rebecca Kush, Chief Scientific Officer, Elligo Health Research Kush discussed data usability challenges from a platform perspective. She shared a Venn diagram, originally created in 1997, and said it represented an approach for automating electronic health records extraction of clinical research case report form data in order to optimize clinical research.
|
From page 95... ...
In addition, she said there has been a proliferation of common data elements, some of which are not necessarily standards, and can potentially leave data gaps in databases, including inadequate metadata. To address the challenge of low interoperability among networks, FDA has worked on a project with other federal agencies, and with funding from the Patient-Centered Outcomes Research Institute trust fund, to harmonize these four common data odels.
|
From page 96... ...
He said, for example, that dose-finding studies would be relevant to share. He explained that his intention is not to restrict sharing but to "set a target for starting, get the data processes right … and eventually expand it to all trials." Bertagnolli said the ncology clinical trial groups are continually funded and supported o data centers that conduct many trials, and that all of the publication datasets likely are shared via platforms.
|
From page 97... ...
Kush mentioned the Mobilizing Computable Biomedical Knowledge initiative,9 as well as a call for papers describing "computable knowledge" by the journal Learning Health Systems.10 Replication of Studies Following up on Helfand's remarks on replication studies, Joseph Ross clarified that there has been only one study using data from the Yale University Open Data Access (YODA) Project for the specific purpose of replicating a particular trial, and there were some discrepancies between the primary report and the secondary analysis.
|
From page 98... ...
Data requests are reviewed by the Alliance working group, and also by the original study statistician, who can best address questions about the feasibility of the proposal. The statistician is also usually engaged in the secondary analysis.
|
From page 99... ...
Alliance researchers engage if asked, she said, but all requests for access to publication datasets are handled by the platform. Sydes asked whether there is information about the extent to which contact with original study teams is made through a platform versus directly.
|
From page 100... ...
Sponsors are also developing platform trials in several disease areas, which she said helps to reduce the number of participants needed in control groups and allows for "more meaningful comparisons on both efficacy and safety across different treatments." Choice of Data Standards Alex Sherman observed that shared trial data will likely be in CDISC format as that is the format required by FDA for regulatory submission, but said that CDISC is not intuitive to many researchers. He asked Kush if other formats might be better for sharing.
|
Key Terms
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.