Lung cancer trial enrollment dropped 43% amid COVID-19 pandemic
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Enrollment in lung cancer clinical trials declined by more than 40% amid the COVID-19 pandemic, according to results of a global survey presented at International Association for the Study of Lung Cancer World Conference on Lung Cancer.
The largest decline occurred early in the pandemic. Trial enrollment began to improve after sites implemented mitigation strategies, even though the pandemic worsened.
“We knew, subjectively, the pandemic created many issues for lung cancer clinical trials across the world. However, we needed quantitative data to confirm this, help us understand what happened and learn from it,” researcher Matthew P. Smeltzer, PhD, associate professor in the division of epidemiology, biostatistics and environmental health at University of Memphis, told Healio.
Smeltzer and colleagues surveyed investigators and collected monthly enrollment data for lung cancer clinical trials worldwide from 2019 to 2020.
They also sent 64-question surveys via email to select trial sites to assess the impact of COVID-19 on the conduct of trials and identify the mitigation strategies most frequently used.
The analysis included data from 173 clinical sites participating in 171 lung cancer clinical trials in 45 countries.
Results showed trial enrollment declined by 43% from 2019 to 2020 (incidence rate ratio = 0.57; 95% CI, 0.37-0.88), with the most dramatic decreases occurring between April and August 2020.
The year-over-year differences in enrollment between October-December 2019 and October-December 2020 were significantly smaller despite marked increases in COVID-19 cases across the world at the end of last year, Smeltzer said.
“Given the disruptions in health care delivery the pandemic caused across the world, I think we all expected to see the initial drop off in clinical trial enrollment. I was not expecting to see the gaps in enrollment start to close so quickly toward the end of 2020. ... We were not sure what we would find, so it was definitely exciting to see improvements later in [the year],” Smeltzer said.
The challenges most frequently reported by survey respondents included fewer eligible patients (67%), protocol compliance (61%), suspension of trials (60%), research staff availability (48%) and institutional closures (39%).
One-quarter (26%) of trial sites reported disruptions due to COVID-19 infection among trial participants, and 40% reported disruptions due to exposure-related quarantines.
Researchers also assessed patient-specific challenges and concerns.
Patients’ most common challenges included willingness to visit the trial site (63%), ability to travel (60%) and access to trial site (52%).
Patients’ most common concerns included fear of COVID-19 infection (83%), travel restrictions (47%), ability to secure transportation (38%) and lab/radiology access (14%).
Trial sites and investigators implemented multiple strategies to overcome these concerns and barriers, the most common of which were modified monitoring requirements (44%), telehealth visits (43%), modified required visits (25%), mail-order medications (24%) and altered trial schedules (19%).
In addition, some sites allowed patients to visit non-study facilities for lab services (27%) or radiology services (20%), and some used electronic consent processes (10%) or otherwise altered consent processes (7%).
Survey respondents identified the following mitigation strategies as most impactful: delayed visits (65%), remote monitoring (64%), delayed assessment (62%), institutional review board changes (62%), remote symptom monitoring or diagnostics (59%), and telehealth visits (59%).
The study provided valuable lessons that can help guide design of future trials, researchers concluded.
“Allowing more flexibility in clinical trials could reduce some barriers to participation, even beyond the pandemic,” Smeltzer told Healio. “I think we can find ways to streamline the process and make participation easier while maintaining the necessary scientific rigor. Leveraging technology for things like telehealth and remote symptom monitoring would be a good place to start. These are not novel ideas, but 2020 could be a catalyst to expand the use of technology and find ways to make it accessible for everyone.”
Perspective
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Edward S. Kim, MD, MBA, FACP, FASCO
The information presented by Smeltzer and colleagues is not surprising, as the data collected gives us some insight into the challenges that COVID-19 placed on clinical trials and patients. However, as suggested by the authors, this is not entirely unique to the pandemic as many of the responses would be symbolic of non-COVID times, as well. A worse tragedy than an actual tragedy — like the pandemic — is not modifying our behavior moving forward.
This stress test of the pandemic exposed several important issues that plague clinical trials and patient research. I am focusing on several on my list but there are many others.
Too many in-person visits are required by many protocols. We always default to patient safety, which I am not minimizing; however, telehealth and other technologies need to be utilized to reduce the number of in-person visits required.
Electronic/virtual informed consent still baffles me. Why haven’t we been able to implement this into clinical trials? We do so many sensitive transactions and business electronically, yet we still require a ‘wet’ signature for clinical research studies.
Research staff are essential. They are overworked in many centers due to overburdened, duplicative processes that are unnecessary for conduct of a clinical trial. Finding ways to preserve research staffing will be as essential as our front-line providers.
Finally, I could never comment on clinical trials without the mention of eligibility. Pandemic or not, we need to create clinical trials that allow a real-world population to participate. The effort by ASCO and Friends of Cancer Research to expand clinical trial eligibility has fundamentally led to changes in the Cancer Therapy Evaluation Program protocol template and the FDA issuing guidance documents. If we are going to keep pace with scientific advancements and increase our ability to bring life-saving therapies quicker to patients, we need to urgently change our approach to clinical research.
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Smeltzer MP, et al. Abstract PL02.09. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer (virtual meeting); Sept. 8-14, 2021.
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