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October 30, 2020updated 02 Nov 2020 10:18am

Clinical trials disrupted by slow recruitment continues to grow

By GlobalData Healthcare

Since early March, around 1,000 organisations supporting clinical trials as a sponsor, collaborator, or contract research organisation (CRO) have publicly announced disruptions to planned and ongoing clinical trials in their press releases, Securities and Exchange Commission (SEC) filings, and clinical trial registries, as well as on social media. Companies have delayed the initiation of planned trials or withdrawn them completely, have suspended enrolment in ongoing trials, or have terminated these trials. GlobalData dynamically tracks these disrupted trials and organisations, along with trials that have resumed activity since disruption.

Since June, the number of total disrupted trials has been falling slowly, as shown in Figure 1. The majority of current trial disruptions are now due to trials impacted by slow enrolment, which continue to gradually increase. Trials impacted by enrolment suspension have been on a downward trajectory while clinical trials that delayed initiation have remained steady. This suggests trials that had initiated enrolment before the pandemic with chosen sites and investigators, but then suspended due to Covid-19, are having more success picking up where they left off when enrolment wasn’t impacted.

Within the category of trials currently affected by slow enrolment, one-tenth of these are specifically due to the unavailability of sites and investigators. Many hospitals that serve as trial sites were inundated with Covid-19 patients and may still not be available; likewise, many investigators may have been reassigned to Covid-19 drug discovery trials or treating Covid-19 patients and the activation of sites for non-Covid-19 trials is being deprioritised. As the number of trials that have been impacted by slow enrolment continues to increase, this continues to be an issue. There is also a high risk to subjects in a clinical trial who have a serious chronic or acute condition that affects their immune system, giving them a greater chance of contracting Covid-19 and making them unwilling to enrol in a clinical trial.

The FDA has issued guidance for industry, investigators, and institutional review boards on conducting clinical trials during the Covid-19 pandemic. Methods that could help start or sustain research include virtual visits, phone interviews, self-administration, and remote monitoring. These suggestions could help trials that are being met with subject quarantine and travel limitations, clinical site closures, and interrupted supply chains, especially trials that delayed initiation and trials that have been impacted by slow enrolment. Importantly, the total number of disrupted trials is falling and the number of clinical trials that have resumed continues to rise (Figure 2). This implies that sponsors and contract service providers have begun to adjust clinical trial design strategies and are adapting to the new post-Covid-19 environment.

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