Though the industry was expected to boom with new studies—data shows a significant drop in the amount of new trials started in 2020
It is no surprise that the COVID pandemic severely disrupted operations in many industries, including clinical trials. Some personnel had thought clinical trials were booming during the pandemic era. However, data from clinicaltrials.gov shows a 38% drop in new clinical trials started in 2020, as illustrated in Figure 1.
This trend infiltrates all disease indications, including immunology. While there are apparent reasons why new clinical trials dropped in 2020, I wanted to know if I was missing anything. This sent me on a hunt for information, and I’ve discovered interesting trends, which I will share with you in this article—both apparent and not-so-apparent.
The most common trend discussed amongst executives was study site impact and lack of resource availability for clinical trials. Specifically, study sites, especially medical research institutions, focused most efforts on managing COVID patients and implementing new processes to comply with local COVID regulations to maintain patient care and safety. Additionally, the focus of many research initiatives at sites turned to therapies focusing on COVID, causing delays in study site selection, startup, and approval. “Most institutions have been impacted not just operationally to bring in subjects to execute studies, but also in staffing and moving through their internal challenges to operate trials unless the study is directly related to COVID treatment or vaccines. In my own experience—working on trials, not COVID related—it is possible to keep things moving—but with a lot more hurdles,” said Jeff Harris, MD, PhD, Senior Medical Director at Denali Therapeutics.
Another interesting trend appears to be changing risk tolerance levels from biopharmaceutical executives in launching new studies. To elaborate, biopharmaceutical companies have had to evaluate their portfolios and focus resources on saving existing studies rather than launching new studies, which could have caused a reduction in new studies started. “During this time of unknowns, companies shifted their near-term strategies and mindsets into salvage mode—focusing resources on saving active and top priority studies, and as a consequence, delaying starting new trials,” said Steve Shevel, Vice President Operations, Clinical Development, and Quality at Hawthorne Effect, Inc. Other risks include sponsors exhibiting fear of patient safety and liability issues regarding COVID infections. “One of the major challenges I saw was around ensuring patient safety and evaluating liability during the pandemic. Of course, we don’t want to put patients in danger by requiring them to attend study visits at sites that were not prepared to employ local recommendations for social distancing and PPE to protect patients from contracting COVID,” said Glenn Morrison, Vice President, Neurology Clinical Development at Alector. “We had to conduct study site reviews to ensure they have the necessary SOPs and COVID prevention processes to protect patients,” added Morrison.
One of the challenges is supply chain-related disruptions. For example, supplies used to manufacture investigational product and lab kit availability were disrupted, halting new trials and causing delays in ongoing trials. “We saw supply chain issues, especially from the labs, focusing much of their efforts on COVID testing and providing supplies for COVID. This resulted in supply chain issues from materials to lab kits,” said Glenn Morison of Alector. “We have seen impacts on biologic manufacturing, where resources and supplies were focused on COVID needs, which resulted in delays of new trial material availability,” indicated Adriana Manzi, Managing Director at Atheln Inc.
Since COVID became an issue, regulators focused on guiding the industry to operate their active trials during COVID and advance COVID therapies. The shift in priorities caused delays and slower response times, which could have also contributed to reducing new trials. Steve Shevel of Hawthorne Effect indicated, “the FDA refocused its resources towards emergency use authorization (EUA) diagnostics and treatments for COVID. Any new trials that did not have a focus on COVID would not get looked at by the FDA, so companies started backing off from launching new trials.”
Suppose anything good came out of the pandemic. In that case, it is the fact that investments are pouring into biopharmaceuticals, and investors are taking more risk, which will not only likely result in a surge in new clinical trials started over the next several years but also advance science and new medicines to new and unprecedented levels. “I observed more investments in the preclinical space. We went through this cycle where there would normally be an investment in companies that had already de-risked the issues that might emerge in the development process, so they were focusing on companies with late-stage assets. We are seeing a renewed interest in investing into bacterial and viral research, and a carry-over effect is a renewed interest by investors into companies that work on drugs to treat infectious diseases,” said Pamela D. Garzone, Chief Medical Officer at Calibr, a division of Scripps Research, Inc.
Another good outcome of the pandemic is that it has fast-forwarded the use of decentralized clinical trial technologies; the use of such technologies was slowly gaining ground; however, they are now front and center in clinical trial adoption and investor interest. For example, THREAD research recently secured $50M in funding1, and Medable raised $91M.2 “The unforeseen benefits of the pandemic include driving clinical trial execution into the 21stcentury. Using digital tools and employing virtual study design are allowing patients to participate in their own homes. These approaches will benefit clinical trials in the future, as they make our studies more resilient,” added Glenn Morrison of Alector.
The pandemic has disrupted the world, and clinical trials were not excluded, as indicated by the drop in new trials started, and issues including study sites, lowered risk tolerance levels by biopharmaceutical companies, supply chain disruptions, and shifts in regulatory priorities. However, disruptions tend to be associated with new opportunities, and current opportunities include increasing risk acceptability by investors into earlier-stage biopharmaceutical companies and migration into digital and virtual solutions to clinical trial conduct.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.