CLINICAL TRIAL DISRUPTION
These patients would typically have biannual or annual visits. Even patients with mild symptoms would defer visits, he says. At present, most practices are likely to be seeing
an above average number of patients as they are making up for skipped visits in the past two years, Budoff says. Companies are seemingly also playing catch-up on clinical trial initiation, with some that have delayed their trials in the past two years now starting or looking to start trials, he adds. Here arises a challenge: the potential for trials initiated would outnumber the patients available to participate in trials, he notes.
Substance-related disorder trials face delays Following a summer of high disruption in 2020, initiation delays quickly recovered to near pre- pandemic levels for most indications. However, certain conditions continued to experience high delays after the peak of the pandemic passed. Solid tumour trials, for example, with a significant delay rate of just 9% prior to the pandemic, saw a doubling of trials delayed over six months in the summer of 2020. For trials due to start towards the end of 2020, the last point at which this analysis is methodologically feasible, the significant delay rate remained at 20%.
Other conditions that saw a sharp increase in trials delayed over six months during 2020 included psychiatric and mental disorders, as well as substance-related disorders and cerebrovascular disorders.
Substance-related disorders investigator Steven
Shoptaw, PhD, director of the Center for Behavorial and Addiction Medicine at UCLA, says bureaucracy is the biggest obstacle to getting clinical trials started. “I have never seen the slowness of bureaucracy I see today. Two years of perpetual delays, meaning it’s hard to get papers off the desk.” Funding, regulatory, and IRB reviews were a lot slower in the past two years and at present, even slower than pre-pandemic, he adds. And this is frustrating, as there is a public health urgency surrounding substance abuse, particularly in Los Angeles, notes Shoptaw. One of the challenges faced by substance- related disorder trials is that they are not well suited to the inclusion of certain decentralised approaches, Shoptaw adds. These clinical trials need a sense of social connection and so certain digital approaches like telehealth are not ideal. Participants need to feel connected, to feel a part of
Certain conditions continued to experience high delays after the peak of the pandemic passed. Solid tumour trials saw a doubling of trials delayed over six months in summer 2020
the treatment and research experience, he says. But this does not mean decentralisation has been
done away with altogether. Shoptaw is involved in running a clinical trial with a medical van going directly to drug addiction patients who also have infectious diseases like HIV. Clinical Trials Arena also previously reported on the challenges of a direct-to-patient approach, specifically on remote drug deliveries.
US trials more likely to register major delays One final finding is that single-country trials located in the US were the most likely to register significant delays to initiation during 2020. In the previous two years, fewer than one in four single-country US trials ultimately began more than six months after their initial planned start date. During the pandemic this figure rose sharply, peaking at 43% for trials due to start during the first quarter of 2020. Initiation delays were also significant for single-country trials in the UK, while trials spread across multiple countries and those located in China reported fewer substantial increases in delays due to the pandemic. As we look ahead to the next stage of the pandemic, many challenges remain. Staff shortages, and delayed funding and regulatory reviews are all limiting factors in trial activity. The risk of more virulent COVID-19 variants that may emerge are also on the minds of investigators, with their potential to shake up operations. Nevertheless, this analysis adds further evidence that decentralised clinical trial elements will still be used as lockdown measures are eased. In fact, any clinical trial approach that ensures investigations are as nimble as possible will likely gain uptake to allow studies to rapidly adapt to a changing world. As Liebeskind puts it: “Times have changed – and as a result, clinical trials have to
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