While 2016’s landmark 21st Century Cures Act is successfully advancing medical research and inspiring a new era of medical innovations, a rare bipartisan effort on Capitol Hill dubbed “Cures 2.0” is looking to build and expand on that work.
At its core, Cures 2.0 is an effort to modernize coverage of and access to life-savings cures in the United States and across the globe. Other areas of significant focus include advancing digital health capabilities and harnessing real-world evidence (RWE).
“We believe that digital health technologies hold the promise of modernizing U.S. healthcare in ways that transform how Americans access medical services,” write co-sponsors U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI). “Digital technologies have helped to transform other sectors of the U.S. economy in ways that improve access to products and services and decrease their costs without harming quality. It is time for that same transformation to occur in healthcare.”
However, it’s also important to include clinical research workforce competencies, standards, training, and other elements front and center in the discussion, Association of Clinical Research Professionals (ACRP) Executive Director Jim Kremidas says. “We’re big supporters of new technology and process innovations like the use of RWE, but we want to make certain the workforce is on the radar screen as these worthy projects are being developed,” he notes. “A well-trained, robust workforce will be the foundation for any successful effort to advance research and development and access to care for patients.”
In a comment letter to the U.S. Food and Drug Administration (FDA), ACRP urges lawmakers to consider policy that would begin to address the “competency of tomorrow’s clinical research workforce.” For example, ACRP believes the FDA should ensure a process exists to assess the competency of personnel conducting clinical research based upon the work of the Joint Task Force for Clinical Trial Competency.
ACRP also urges lawmakers in its comment letter to consider integrating clinical research into clinical services, to help drive innovation and improve access to therapies under development.
“Recognizing clinical research as an option for care would greatly enhance the development of new therapies and provide access to innovative services to millions of patients,” ACRP says in its comment letter. “We believe that clinical research should be recognized as a subspecialty in medicine, just as emergency medicine and other specialties have been recognized.”
Author: Michael Causey