Robert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute (PCORI) and studies conducted by the national Patient-Centered Clinical Research Network (PCORnet).
The PCORI web site said its board of governors has agreed to provide up to $25.4 million in additional infrastructure-building funds to support the long-term sustainability of PCORnet through PCRF, which was formed by PCORnet investigators to advance and support the network’s sustainability.
On its web site, PCRF said it would provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials. “Each study will deeply engage patients and clinicians in its design, conduct, and dissemination. A balanced mix of support from government, foundations, and industry will sponsor the studies. All projects will be aligned with the foundation’s mission of centering projects around the needs of people and their health.”
Califf also has returned to the Duke Clinical Research Institute, which he founded in 2006, as the Donald F. Fortin professor of cardiology. In a letter on the nonprofit’s web site, he said that PCRF would integrate people into all phases of research and the learning health system. “Patients, participants, patient advocates, and caregivers will constitute a meaningful percentage of our board; be involved in leadership roles in all committees; and participate in the development and execution of the research.”
He added that PCRF has a robust business plan in place, with seven members of what could grow to be a 13-member board, and plans to build a program management office that will be led by an executive director. The other board members are:
• Richard Bankowitz, MD, MBA, FACP, Executive Vice President, Clinical Affairs, America’s Health Insurance Plans (AHIP)
• Josephine P. Briggs, MD, Director, National Center for Complementary and Integrative Health (NCCIH)
• Marc M. Boutin, JD, Chief Executive Officer, National Health Council (NHC)
• Donna Cryer, President & CEO of the Global Liver Institute
• Craig Lipset, MBA, Head of Clinical Innovation, Worldwide Research & Development, Pfizer Inc.
• Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson