Modified Monitoring Requirements, Telehealth Increase Lung Cancer Clinical Trial Enrollment in COVID-19 Era

Matthew P. Smeltzer, PhD

Flexible patient-focused approaches may increase clinical trial accessibility and enrollment in international lung cancer clinical trials beyond the COVID-19 pandemic, shared Matthew P. Smeltzer, PhD, at a virtual press briefing during the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer.

Findings, which evaluated international lung cancer clinical trial enrollment before and throughout the pandemic, showed a derived benefit from flexibility in “place” and “time” to increase trial participation.

More specifically, trial sites reported that the most effective strategies to mitigate COVID–19-related challenges included telehealth visits, remote diagnostics, remote patient-reported symptoms, and remote consenting alternatives to address issues associated with trial “place.” To achieve flexibility in “time,” the findings suggested allowing delayed assessments and visits, as well as IRB changes.

“Overall, a more flexible approach, [and] removing unnecessary barriers may improve enrollment and access to clinical trials, even beyond the pandemic,” shared Smeltzer, an associate professor of epidemiology and biostatistics at the University of Memphis.

The study looked at the enrollment data from 173 clinical trial sites and 171 trials, across 45 countries. Data assessment included enrollment numbers from before the pandemic, in 2019, and continued across 2020 and 2021.

Significant disparities in enrollment were observed between 2019 and 2020. The average number of monthly trial enrollment shifted from 3.2 to 2.5 between April 2019 to April 2020. Similar changes were observed in May (3.4 to 1.8), June (3.1 to 1.5), July (3.2 to 1.7), and August (3.0 to 2.0).

The investigation considered results from a data collection survey which evaluated aggregate monthly enrollment for international lung cancer trials between 2019 to 2021, as well as from an action survey, which assessed the impact of COVID-19 on the conduct of clinical trials and identified mitigation strategies used.

“So, where the [changes] are the most discrepant was at the beginning of the pandemic and April to August. But we see, by September to December, the gap starts to close quite a bit,” explained Smeltzer. “And it looks like, relative to 2019, monthly 2020 enrollment started to rebound despite the drastic increase and total COVID-19 cases diagnosed each month across the world.”

Researchers then put together a survey to better understand how the pandemic specifically impacted the trial sites.

The surveys found that the most frequent site challenges included fewer eligible patients (67%), protocol compliance (61%), suspension of trials (60%), research staff availability (48%), and institutional closures (39%).

“Many trials were suspended,” Smeltzer summarized. “And so that was a challenge. Availability of research staff was [also] a major challenge, and institutional closure. These are all challenges that were sort of at the institutional level."

The surveys also gained insight into the concerns and challenges faced by patients themselves. Sixty-three percent of patients reported that a willingness to visit trial sites was a challenge to participation. An ability to travel accounted for 60%, whereas access to trial site was reported to be a challenge by 52%. Forty percent of patients shared that an exposure-related quarantine impeded on their ability to participate in a trial, while 26% shared that a COVID-19 infection prevented their participation.

In addition, fear of COVID-19 infection (83%), travel restrictions (47%), securing transportation (38%), and lab-radiology access (14%) made up the bulk of concerns patients had in relation to lung cancer clinical trials between 2020 and 2021.

To respond to these challenges and concerns, trial sites implemented a variety of mitigation strategies. Besides the most effective strategies mentioned above, common mitigation strategies included modified monitoring requirements (44%), telehealth visits (43%), labs at non-study facilities (27%), modified required visits (25%), and mail-order medications (24%).

“We asked them ‘What were the most frequent mitigation strategies that they used? What did they do to try to improve the conduct of the trials both in terms of enrollment and compliance?’’’ said Smeltzer. “Modifying monitoring requirements was the No.1 response followed closely by telehealth visits.”

Other popular strategies involved radiology at non-study facilities (20%), altered trial schedules (19%), electronic consent processes (10%), and an altered consent process (7%).

“We think there's some good lessons learned here,” said Smeltzer. He concluded by sharing that the results of this trial provide a good base assessment into the rigor needed to maintain the value and quality of clinical trials while also allowing flexibility to ensure that trials are feasible, accessible, and patient friendly. Furthermore, researchers are optimistic that the results of this assessment will continue to be beneficial beyond the COVID-19 pandemic.

Reference

Smeltzer MP, Bunn PA, Clark R, et al. Study of the impacts of COVID-19 on international lung cancer clinical trials. Presented at: 2021 World Conference on Lung Cancer; September 8-14, 2021. Virtual. PL02.09