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No lack of partners
SOUTH SAN FRANCISCO, Calif.—Increased participation in clinical research is a key need for the industry. While unexpected drug toxicity is the cause of most clinical trial failures, insufficient patient enrollment is the cause of most trial delays. In fact, estimates are that less than 10 percent of the U.S. population participates in clinical research. Verily, an Alphabet subsidiary, is hoping to take aim at that issue, having announced the addition of four new partners to its Project Baseline initiative thanks to a series of alliances. The company will be working with Novartis, Sanofi, Otsuka and Pfizer Inc. on the development of patient-centered clinical research programs.
“If we are truly to achieve the realization of patient-centered care, we must advance innovative research methodologies that focus on the patient and their needs, values and lifestyles," Dr. Reed Tuckson, chairman, Project Baseline Advisory Board, commented in a statement. "Project Baseline, in collaboration with these innovative companies, is well positioned to achieve this vision and have a transformative impact on research.”
Project Baseline launched two years ago, with its first undertaking consisting of the Project Baseline Health Study. Conducted in partnership with Duke University School of Medicine, Stanford Medicine, Google and the American Heart Association, the initiative aimed to develop tools and technology to better map human health. The project has since expanded thanks to a variety of alliances, and Verily's Baseline Platform seeks to engage increased numbers of patients and clinicians in research, accelerate and streamline studies, and collect better data. And earlier this year, Verily kicked off Research Goes Red in tandem with the American Heart Association, a project that will seek to increase women's engagement in research and connect patients with research opportunities.
According to Dr. Debbie Profit, vice president, applied innovation and process improvement, Otsuka, “The clinical research process is antiquated in many ways. Our collaboration with Verily aims to redefine and redesign this process to make clinical trials more accessible to patients, and clinical research more precise and targeted so we can obtain results and seek approvals sooner, which would put therapies into the hands of physicians and their patients earlier. As an early adopter of the Baseline Platform, we have the opportunity to leverage real-world data, through sensors, EHR integrations and other tools to corroborate evidence around the treatments and interventions we are studying—while reducing the burden on clinical trial participants.”
“At Novartis, we are advancing treatments that stand to change the course of disease, or even offer cures, but our ability to bring new medicines to patients quickly is often hampered by inefficient or limited participation in clinical trials,” noted Badhri Srinivasan, head, global development operations, Novartis. “By combining our complementary sets of expertise, we have the opportunity to develop a new trial recruitment model that gives patients and their physicians greater insight into the process of finding treatments for their disease, and how they can participate.”
Verily and its partners are looking to establish an approach to clinical research that focuses more on the patients and integrates more technology, boosting patients participation and diversity as well the generation and use of clinical data. Over the course of this alliance, Sanofi, Otsuka, Pfizer and Novartis will all be initiating clinical studies that leverage the Baseline Platform in a variety of therapeutic indications, including oncology, cardiovascular disease, diabetes, mental health and dermatology.
“Evidence generation through research is the backbone of improving health outcomes. 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,” remarked Dr. Jessica Mega, Verily's chief medical and scientific officer. “Novartis, Otsuka, Pfizer and Sanofi have been 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.”
This news comes just days after Verily announced alliances with more heavy hitters. On May 16, the company reported that it had kicked off another Project Baseline initiative: the Baseline Health System Consortium. Verily is joined in this initiative by Duke University Health System, Vanderbilt University Medical Center, Mayo Clinic, University of Pittsburgh, University of Mississippi Medical Center and Regional Health in South Dakota. This effort will seek to identify and develop solutions for challenges in clinical research, such as making it more accessible and engaging. The partners will launch a pilot this year to examine existing research programs to determine ways to accelerate trials and not just generate better evidence, but also better ways to capture it.
“The clinical research system fails to provide the evidence that patients and clinicians need to make good health and healthcare decisions,” Dr. Robert Califf, former FDA commissioner and advisor, Verily, said at the time. “By developing useful tools and approaches, this robust collaboration has the potential to drive more efficient and effective research as we link patients, advocacy groups, clinicians, health systems and researchers.”