The Duke Clinical Research Institute (DCRI) and CardioVascular Clinical Trialists (CVCT) have announced a formal three-year partnership to establish a clear pathway to regulatory and clinical acceptance of cardiovascular prevention therapies. Titled "Pathway to Prevention," the initiative will unite stakeholders from academia, industry, government, nonprofits, and the technology sector to develop practical guidance to advance prevention indications.
The initiative will culminate in actionable guidance and is structured around three core programs: Pathway to Approval, Pathway to Access, and Pathway to Adoption. Each program will combine DCRI-led Think Tanks with CVCT-led sessions at the annual Global CVCT Forum, fostering ongoing dialogue among the experts who influence the development, evaluation, and delivery of therapies to patients.
"The DCRI and CVCT have been aligned in mission since our early years,” said DCRI Executive Director Adrian Hernandez, MD, MHS. “Both organizations are committed to advancing the science that ultimately improves health for people around the world. We now have therapies with real potential to prevent health problems like heart failure before they take hold. However, the regulatory, payer, and evidentiary frameworks haven't kept pace. This collaboration is about closing that gap by bringing together the right voices to define what a credible, rigorous pathway to prevention of major chronic cardiovascular health conditions actually looks like and then building it."
The first program, Pathway to Approval, will begin with a DCRI-led Think Tank Aug. 12–13, 2026, followed by CVCT-led sessions Dec. 7–9, 2026. DCRI’s Therapeutic Area Lead of Cardiovascular Research, G. Michael Felker, MD, will co-lead the effort alongside Javed Butler, MD, president of Baylor Scott & White Health. Heart failure, atherosclerosis, and other cardiometabolic conditions will serve as primary use cases to explore viable regulatory pathways for prevention at both meetings.
The program will examine how to establish the evidence required to support prevention indications, identify and address current data gaps, and design studies that meet regulatory and safety standards for lower-risk populations.
"The science and regulatory framework of cardiovascular prevention clinical trials needs to evolve so as to accelerate evidence generation and approval of innovative preventive therapies,” said Faiez Zannad, MD, PhD, founder and chairman of CVCT. “The DCRI and CVCT will synergize skills they have developed in fostering productive multi-stakeholder debates."
The second program, Pathway to Access, will focus on the payer landscape, exploring how to demonstrate the economic value of prevention therapies, design studies that show short-term benefits, and define cost-effective thresholds to support coverage and reimbursement decisions across both private and public payers.
The final program, Pathway to Adoption, will address how to demonstrate value to patients, providers, and payers over both the short and long term. It will emphasize precision trial design that incorporates patient voices and preferences while balancing the financial burden of long-term therapies against their downstream benefits.
This formal partnership builds on the long-standing relationship between the DCRI and CVCT, which have collaborated on numerous DCRI Think Tanks. By formalizing their collaboration into a structured, multi-year initiative, both organizations reaffirm their commitment to ensuring that the evidence and guidance they produce reach the stakeholders best equipped to act on it.