The Academy of Physicians in Clinical Research (APCR) Board of Trustees met today to address policy issues concerning the COVID-19 crisis. APCR represents and unites physicians working in clinical practice, academia, industry, government and consulting who participate in the process of developing and disseminating new medical diagnostics and treatments.
APCR wishes to reassure the public that the scientific understanding of viruses and anti-viral therapies has greatly improved in recent years. The US and other developed countries have sophisticated capabilities to conduct clinical trials to advance medicine and collect data for product approvals. Successes such as the development of the anti-viral therapies proven effective against HIV and hepatitis can now occur at a very rapid pace using molecules specifically targeted to the characteristics of the pathogen. Organizationally, and as individual physicians, we are poised to respond to this medical crisis. Several promising medical solutions for COVID-19 have begun testing. We believe, in a short time, effective treatments will emerge to limit the virulence and transmissibility of the new virus.
The APCR Board of Trustees makes the following policy recommendations:
- The COVID-19 crisis justifies the suspension of “business as usual.” Clinical research methods strictly adhere to the concepts of the protection of the rights and welfare of patients. In times of crisis, the fastest pathway to medical solutions provides the best protection for patients.
- Solving COVID-19 requires a medical solution to both reduce human suffering and for getting the world economy back on track as quickly as possible. Medical answers rather than “politics as usual” provide the surest cost-effective pathway to minimize economic uncertainty and fear.
- Well-intended government regulatory requirements can slow the process of starting clinical trials and disseminating promising therapies, particularly if product development requires non-traditional study designs. These barriers should not prevent rapid medical responses. Therefore, we advocate the creation of emergency “on call” committees of the FDA and Institutional Review Boards (IRBs) to immediately assess and approve scientifically valid protocols using therapeutic agents and vaccines to treat and prevent the transmissibility of COVID-19. Prophylactic treatment of high-risk patients should become a priority using products that have already undergone basic safety assessments.
- Liability concerns create a major barrier to rapid deployment of new therapeutics. The federal government can play an important facilitating role, by limiting and insuring for this liability. APCR applauds today’s declaration by Health and Human Services Secretary Alex Azar extending the protections of the 2005 Public Readiness and Emergency Preparedness Act (PREP Act) to cover the liability risk for approved protocols.APCR believes this decisive action has the potential to accelerate tremendously the ability of the private sector to develop COVID-19 solutions.The language of government documents, including the declaration, can be complex. To maximize the effect of Secretary Azar’s action, we ask HHS to make available personnel to answer questions from individuals and institutions involved in the fight against corona virus.
- Governments can make funds available for active, proven clinical trial sites to prepare for the challenges of conducting COVID-19 treatment and transmission prevention research. These preparatory measures should include ways for infected or possibly infected patients to seek clinical trial opportunities without endangering other patients who seek other types of care. Deploying clinical trial personnel to the home setting for ill patients and assisting local public health authorities with the requisite testing and follow-up resources to understand the epidemic would quickly expand the pool of capable medical personnel to address the crisis. Funding for clinical trial centers could come in emergency grants that equal a percentage of average revenue from clinical trial activity over the past 3-5 years to insure that experienced clinical trials centers – both public and private - receive the funds rather than upstarts created for the purpose of self-advantage during a crisis.
- Policy makers should swiftly reject proposals that up-end current collaboration between the private and public sector and undermine the existing process for tech transfer established by the Bayh-Dole Act. Continued collaboration by public and private sector researchers is critical to ensuring we develop solutions to combat COVID-19.
- Computer models have identified available anti-viral agents that may have effectiveness against COVID-19. Clinical trial testing should prioritize these molecules.
APCR has started an electronic petition that we intend to send to the US President and Congress and all US governors. We encourage physicians to show their support for the above recommendations by endorsing this petition.
About APCR- The Academy of Physicians in Clinical Research is a not-for profit association that reports to the American Medical Association House of Delegates. To learn more about the organization please visit APCRnet.org.