COVID Exposes the Cracks in Trial Problems

While GlobalData recently reported that interruptions of clinical trials due to COVID-19 have been on the decline since June, this article, also from GlobalData, detailed the reasons behind trial disruption. The primary one, at 67.3%, was suspension of enrollment; delayed initiation of planned trials followed at 18.4%, and slow enrollment at 14.4%. Of the trials affected by the latter, 20.7% were due to the availability of sites and investigators.

The majority of disrupted trials were in Phase II, at 44.8%; Phase I, with 26.1%; Phase III, at 21.7%; and Phase IV, with 7.4%. By therapeutic area, oncology has the highest number of disrupted trials, with 33.3%, followed by CNS, at 16.1%, infectious disease (9.3%), gastrointestinal (9.1%), and respiratory (7.7%).

But, as the data showed, trials are coming back again. And that’s where the cracks in the traditional approach are being exposed. It is why so many articles and observations from experts in clinical trials were calling on the industry to adapt, learn, and change so the fundamental breakdowns in clinical trials can be addressed. You can peruse our online articles and blogs from the past four months for a clearer picture of the calls to action.

One of those articles we posted was from Gen Li, PhD, president and founder of clinical development analytical products and services provider Phesi. In this article, Li urges the industry to reexamine its delayed, suspended, or low-enrolling studies on a deeper level. Clearly, sites and investigators were unavailable during the early days of the pandemic in the Northeast and now again in the South. But what other factors existed besides COVID?

Li suggests that many trials are poorly designed from the outset, “so their execution is intrinsically flawed—and would be highly likely to fail or require rescue, even if COVID-19 had never happened.” Specifically, Li says that poorly executed site activation is one of the main drivers of slow patient enrollment. If sponsors now take a data-driven approach, by identifying high-performing sites or finding the most relevant CRO with a performance record in the indication under study, they could potentially avoid a trial destined for failure.

Another area of examination? Competition between studies and sites, which has significant impact on patient enrollment. Li uses the example of the number of recruiting sites in Crohn’s disease that increased in the three years before COVID-19, from under 2,000 to more than 9,000, and without acknowledgment of the limited patient population. This has led to poor country allocation and site selection. It leads to the reality that some of these programs will have to be terminated and reallocated to those with the best chance of succeeding.

Many have taken advantage of the processes and technologies to help overcome the limitations of trials compounded by the pandemic. We look forward to showcasing more success stories around these technologies as well as their acceptance by the global regulatory authorities to ensure trial continuation. But for long-term change, it will take a concerted effort by many to keep trials moving in an upward motion toward excellence.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com. Follow Lisa on Twitter: @trialsonline.