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Improving access to trial data
04-24-2018
by Jeffrey Bouley  |  Email the author
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BOSTON—April 23 saw an announcement from ClinicalStudyDataRequest.com (CSDR)—an online resource giving researchers access to patient-level clinical trial data from 14 of the world’s leading pharmaceutical companies across multiple therapeutic areas—that it had formed new strategic collaborations with four major non-profit partners: the Bill & Melinda Gates Foundation, Cancer Research UK, Medical Research Council and Wellcome Trust. The new consortium partners are expected to expand CSDR’s ability to deliver upon its promise, which, as CSDR puts it, is “to help accelerate life-saving discoveries and efficiently translate big data into smart data that generates valuable research results.”
 
CSDR has been on the scene since 2013 and since that time, the organization says it has demonstrated “steady growth” with regard to both how many pharmaceutical partners have been making their data available to the research community and the number of researcher proposals submitted through what CSDR calls its “one-stop shop for accessing de-identified patient data from the more than 3,500 studies worldwide.”
 
“Making clinical trial data available to biomedical researchers across all geographies will help improve academic and clinical research activities, the drug development process, and ultimately, enhance patients’ health outcomes,” said Scott Martin, chair of the CSDR Steering Committee. “CSDR is pleased to join forces with such outstanding research collaborators who share our vision of safeguarding privacy while enabling transparency around the vast amounts of valuable data borne from clinical trials.”
 
So far, 57 researchers who accessed data through CSDR have already published or have pending publications in scientific journal related to their findings.
 
“Data is one of the biggest outputs of the research that Wellcome Trust supports, and we support CSDR’s goal of ensuring that it is shared in a way that is independent, transparent and equitable to reduce the barriers of data re-use,” remarked Jennifer O’Callaghan, clinical data sharing manager with Wellcome Trust. “CSDR addresses the needs of the academics whom we fund by providing them with a single, innovative solution for accessing and analyzing data from multiple trials as a means of saving time and effort—altogether maximizing the value of the research that we fund and creating an opportunity to make academic clinical trial data more discoverable, accessible and reusable for optimal impact and value. We strongly encourage our researchers to use CSDR for sharing and accessing trial data.”
 
CSDR recently launched a redesign of its website to improve the user experience in general and make it more efficient in particular. With the addition of non-profit partners, CSDR says it “is uniquely positioned to not only serve the research community through unparalleled access to patient-level clinical data from the pharmaceutical industry, but also as a resource through which academic-led clinical trial data now can be shared.”
 
As clinical trial data sharing continues to expand, CSDR notes that both the U.S. Food and Drug Administration and the European Medicines Agency have instituted basic requirements to support clinical trial transparency and data disclosure. That said, both agencies continue to call for improvements around the scope, clarity, consistency and usability of disclosed data.
 
CSDR says it hopes to help answer that call with its systems and mechanisms for ensuring privacy of trial subjects while also facilitating expedited advancement of scientific discoveries and innovations.
 
Of course, access to patient data from trials requires that patients enroll in trials. And so, in other and slightly different clinical trial access news about a month before the CSDR announcement, Austin, Texas-based Elligo Health Research—which says it improves clinical trial access by engaging the 97 percent of physicians currently not offering clinical research to their patients—announced a $16-million in Series B funding led by Hatteras Venture Partners and Noro-Moseley Partners with participation from FS Healthcare LLC, Excelerate Health Ventures and all existing Series A investors, including Shumway Capital.
 
“Our programs speak specifically to the medical practices that are hesitant to perform research in their offices due to lack of resources and infrastructure,” noted Dr. John Potthoff, CEO of Elligo. “The new funding will help us expand our services and not only make research studies more accessible to physician sites but also streamline data collection and submission processes.”
 
“The investment will enable us to accelerate expansion of our network of physicians and refine our technology platform to improve study efficiency,” added Chad Moore, Elligo's president. “And, every day we are one step—one study, one patient, one physician—closer to fulfilling our mission of improving clinical research and bringing new treatments to market faster by making it easier for physicians and patients to participate.”
 
Code: E04251801

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