CVS Health announced its new Clinical Trial Services business to help solve challenges, drive greater access to clinical trials across the communities it serves and create a more efficient, convenient experience to improve participant retention and research effectiveness.
Clinical trials are critical in evaluating the safety and efficacy of investigational new drugs and devices and making them available to those who need them. Despite their importance, less than 4% of the U.S. population participates in clinical studies. In addition, 80% of studies don't meet participant enrollment deadlines, and an average of 30% of participants drop out before a study is completed.
"Traditionally low patient enrollment, diversity and engagement coupled with inconvenient trial sites, challenging study participation requirements, including the length of participation, show the need to improve the current model particularly in response to the COVID-19 pandemic," said Troyen A. Brennan, M.D., MPH, Executive Vice President and Chief Medical Officer of CVS Health. "Combining clinical trial expertise from across the CVS Health enterprise with our growing connection to the communities we serve, will help create a new clinical trial experience that works better for participants, health care providers, clinical research organizations and study sponsors."
CVS Health Clinical Trial Services is working with key stakeholders in the biopharmaceutical industry and across the clinical trial ecosystem to design and deliver innovative approaches to research and real-world evidence generation. The new business will initially focus on scaling three core capabilities:
· Precision patient recruitment: Leveraging analytics, national reach, and local community connections to engage individuals by helping them learn about clinical trial opportunities that may be appropriate for them
· Clinical trial delivery: Innovative, decentralized options for the delivery of Phase III/IV clinical trials and real-world evidence studies at CVS locations, at home or virtually
· Real-world evidence generation and studies: Retrospective and prospective studies that measure the impact of novel devices and therapeutics in real-world settings
CVS Health collaborated with the pharmaceutical industry to help facilitate clinical trials for investigational COVID-19 vaccines and treatments. Using a specially designed digital model and screening protocols, CVS Health engaged more than 300,000 volunteers who met the study inclusion criteria for COVID-19 vaccine trial consideration and helped them connect to studies close to where they live.
The Clinical Trial Services business will continue to use CVS Health's expertise in both healthcare services and clinical research, including more than 200 in-home clinical trials, real-world evidence studies, and support for publication of peer-reviewed articles.