(Pexels.com)
21 May 2019. Four pharmaceutical companies are signing on to an initiative that promises to make clinical trials friendlier to patients and make better use of digital technology. The companies — Novartis, Otsuka, Pfizer, and Sanofi — are joining Project Baseline, a program offered by Verily Life Sciences, a division of Alphabet Inc., the parent company of Google.
Project Baseline started in 2017 as an effort to streamline the conduct of clinical trials, a key element in the development of new drugs and medical devices, but with continued high costs and difficulty in recruiting participants. Verily cites data from a 2017 survey by the organization Research America showing less than 10 percent of the U.S. population takes part in clinical studies. In addition, clinical trial participants often perceive little direct value from their experience, and data from trials are not easy to aggregate or integrate with other databases.
Taking part in Project Baseline up to recently are the medical schools at Stanford and Duke universities, American Heart Association, and Google. The project is developing standardized and interoperable trial enrollment processes, better integration with electronic health records, and more understandable dashboards and analytics for trial participants and managers. Among Project Baseline’s benefits to participants are faster and more understandable medical test and fitness results returned to individuals.
The four drug makers are joining Project Baseline to advance the initiative’s goals, but are also exploring gaining access to data routinely referenced and collected by the project as real-world evidence of health status and outcomes. Verily says the pharma companies are also planning clinical studies conducted through Project Baseline testing treatments in fields such as cardiovascular disease, cancer, mental health, dermatology, and diabetes.
Jessica Mega, Verily’s chief medical officer, says in a company statement that the four drug makers are “early adopters of advanced technology and digital tools to improve clinical research operations, and together we’re taking another step towards making research accessible and generating evidence to inform better treatments and care.” Mega adds, “We need to be inclusive and encourage diversity in research to truly understand health and disease, and to provide meaningful insights about new medicines, medical devices, and digital health solutions.”
Last week, Verily expanded medical center participation in Project Baseline, adding five more institutions to Duke and Stanford: Vanderbilt University Medical Center, University of Mississippi Medical Center, Mayo Clinic, Regional Health in South Dakota, and University of Pittsburgh. The medical centers plan to run a pilot study this year analyzing their current research programs using Project Baseline’s tools.
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- FDA Expands Evidence Project to Replace Trials
- Blockchain Prototype Designed for Clinical Trial Data
- Wearables Assessed for Clinical Trial Value
- Validation Scheme Proposed for Medical Algorithms
Disclosure: The author owns shares in Pfizer.
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