Ineptitude of Clinical Trials System Highlighted by COVID-19 Pandemic

Copur is a medical oncologist/hematologist at Morrison Cancer Center, Mary Lanning Healthcare, Nebraska, and is a professor at the University of Nebraska Medical Center.

The coronavirus disease 2019 (COVID-19) pandemic has permanently changed many aspects of clinical care, including clinical trials. Bastos and colleagues concisely discuss the main aspects of cancer clinical trial activities that have changed during COVID-19 pandemic and share the recommendations from regulatory agencies for the conduct of clinical trials in the COVID-19 era. A short list of the challenges faced by the entire research community during this pandemic include (but aren’t limited to) enrollment and protocol adherence difficulties, needing to reduce patient visits, staffing constraints, and limited availability of ancillary services.

As the saying goes, “Never let a serious crisis go to waste.” My hope is that the lessons learned from our collective COVID-19 experience will lead to more efficiently conducted clinical trials in the near future. Many of the adaptations we’ve made in conducting clinical trials during this pandemic will hopefully be the start of a broader movement to improve, even transform, our currently inadequate clinical trials system.

COVID-19 is an infectious disease caused by a well-established single etiologic agent; it has simple and easily assessable end points, and hundreds if not thousands of patients are available and willing to participate in clinical trials. Further, numerous promising new preclinical compounds as well as repurposable existing drugs are waiting to be tested on clinical trials. These circumstances have been in place for months, yet we are still lacking a reliable, effective treatment against COVID-19. Compare these circumstances with those for many forms of cancer: There, the etiology is not always clear and it is way more complex than a single virus. It has no simple and easily assessable end points, it is often hard to find enough eligible and willing patients to enroll on clinical trials (the national enrollment rate is a dismal 3%-5%), and there are not as many readily available promising new compounds or repurposable drugs to test. By all rights, we should have come up with some promising effective treatment options for COVID-19 by now, but we have not.

The inability of our existing system to have created multiple high-quality, efficient, meaningful clinical trials by this point, and to have established effective treatments for COVID-19, is, I believe, the confirmation of how imperfect and inadequate our current clinical trials system is. The common obstacles standing in the way of improvement are widely recognized and have been reported: They include inadequate knowledge and understanding of clinical research/trial methodology, lack of funding, excessive monitoring, restrictive overinterpretation of privacy law, lack of transparency, and, most importantly, exceedingly complex, cumbersome regulatory requirements.

The COVID-19 pandemic has irrefutably exposed the inability of our current clinical trials system to conduct pragmatic clinical trials in a timely manner. Breaking down the regulatory barriers between clinical trials and clinical care is desperately needed. There is a huge unmet need to revolutionize our existing clinical trials system to make it more agile and efficient, without compromising either patient safety or integrity of the data.

All the stakeholders in the research community must seize this opportunity to make permanent, positive adaptations to our clinical trials system. Specific improvements, to start, would include more pragmatic and streamlined trial designs and protocols; reductions in clinical trial–related in-person patient visits; reduced sponsor visits; simplification of monitoring; simplification of ethical and regulatory requirements; and most importantly, removing the regulatory barriers that currently paralyze the system. Capitalizing on this moment will require support from federal regulatory and research agencies, comprehensive policy changes by sponsors and contract research organizations, and universal buy-in from the entire research community.