One of the long-term effects of the ongoing COVID19 pandemic is a slowing down of global drug development, leading to less approved therapeutic agents in the coming years. This is the conclusion based on a recent survey by Clinical Research IO, an eSource solution for clinical research sites.

The impact of COVID19 on clinical research and the operations of clinical trial sites will vary based on many factors, including the nature of the disease being studied, the trial design, and in what regions the study is being conducted. Earlier this month, the U.S. Food and Drug Administration (FDA) outlined a number of key considerations to guarantee the safety of trial participants, while maintaining compliance with good clinical practice, and minimizing the risks to the integrity of the clinical study being conducted.

Significant interruptions
The survey shows that investigators conducting clinical trials on a wide range of diseases are experiencing significant interruptions in their trials due to the ongoing pandemic.

Twentyfour percent of investigators being interviewed reported that they have stopped enrolling new patients due to patient safety concerns. From the remaining 76% of investigators, nearly half, or 37%, indicated they are considering halting new patient enrollment.

The interruptions of clinical trials are not only seen within oncology and hematology but are noticed in all therapeutic areas.

Photo 1.0: Elena A. Christofides, MD, FACE, is dual board-certified in Endocrinology, Diabetes, and Metabolism as well as Internal Medicine.

“We noticed a significant slowdown in patient recruitment at the beginning of March,” said Elena A Christofides, MD, FACE, owner and principal investigator of Endocrinology Associates.

“We then decided that it was in the best interest of public safety to halt all further enrollment,” she added.

This slowdown has been further exacerbated by the recent spate of shelter-in-place orders imposed by states and municipalities.

“Due to COVID-19 restrictions in health care, clinical trial activity has largely come to a halt,” noted Marcus Stone, Ph.D., Chief Executive Officer of The Spine Institute of Louisiana Foundation.

“This will lead to a significant slowdown in new drug and device development,” Stone further noted.

“New treatments that could have come out in, say, 2022 now might come out in 2023. So, this COVID19 crisis could have a significant long-term effect on health care in general.”

Raymond Nomizu, co-founder of Clinicalresearch.io. Previously, he co-founded a data analytics company serving over 50 Fortune 500 companies and was a strategy consultant for The Boston Consulting Group. He began his career as a corporate attorney.

Major challenges
Even for trial sites that are continuing to enroll, significant challenges remain.

Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID19. These challenges may lead to difficulties in conducting clinical trials and may require protocol modifications or unavoidable protocol deviations.

The survey indicated that sites are reporting a 9% decrease in patient retention. This means that nearly one in ten enrolled subjects may be withdrawing from their studies. In addition, 63% of trial sites reported that they have prohibited on-site monitoring by pharmaceutical sponsors, inhibiting the ability of sponsors to perform effective oversight.

“This is one of the second-order casualties of the COVID19-crisis,” said Harvard-trained lawyer and former management consultant Raymond Nomizu, Chief Executive Officer of EO of Clinical Research IO.

“When we look back five years from now, I fully expect to see a drop in the number of breakthrough new medications being approved – a drop you can directly tie to this crisis,” Nomizu concluded.

The survey was conducted March 19-23, 2020 and included  73 clinical trial research sites across a range of therapeutic indications.

Reference
[1] Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials. [FDA News release]