Clinical trials involving cancer patients were seriously disrupted by the COVID pandemic, especially during the first wave, but they have slowly regained their momentum and are back to prepandemic levels of activity, concludes a new analysis.
“The good news is that both patient accruals and trial activations gradually recovered during the subsequent period of the pandemic and have now returned to higher-than-normal levels, despite the ongoing nature of the pandemic,” commented first author Chris Labaki, PhD, Dana-Farber Cancer Institute, Boston, Massachusetts.
The finding comes from a study published online June 15 in the Annals of Oncology.
The study evaluated clinical trial activities at two large cancer centers — the Dana-Farber Cancer Institute (DFCI), in Boston, Massachusetts, and the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai (ISMMS), in New York City. Two cohorts were used in the study: an institution-wide cohort of all new patient accruals to cancer trials, and a smaller, manually curated cohort of patients linked to an electronic data capture platform.
“The institution-wide cohort included all new patient accruals to oncological clinical trials at DFCI and MSSM from December 2019 to June 2021,” the authors explain. It included 4756 newly enrolled patients whose median age was 58.2 years on enrollment.
The manually curated cohort consisted of patients with a current or past history of cancer who had an outpatient medical oncology visit at either center on the index week of March 2020.
Compared with the immediate prepandemic period between December 2019 and February 2020, there was a 46% decrease in the number of newly enrolled patients in clinical trials during the first pandemic period from March to May 2020.
This was followed by a progressive recovery during the subsequent periods of the pandemic and a return to normal levels from March to May 2021, the authors note. In fact, the numbers of newly enrolled patients increased by 2.7% during the latter period compared with prepandemic levels, and a similar pattern was seen at both cancer centers, the investigators report.
Among newly enrolled patients at the DFCI, there was a statistically significant increase in the proportion of new patients enrolled to industry-sponsored trials between the prepandemic period (December 2019 to February 2020) and three of the pandemic periods (March to May 2020; June to August 2020; and March to May 2021).
This was in contrast to a significant decrease in the proportion of new patients enrolled in academically sponsored trials between the two periods studied — June to August 2020, and March to May 2021. Similar to what was seen in new patient accruals, newly activated cancer trials at the DFCI also experienced a 23.6% decline early on in the pandemic, from March to May 2020.
This was again followed by a gradual increase during the later periods of the pandemic and eventually increased by over 30% compared to levels of active trials before the pandemic began, the investigators note.
The industry-sponsored trials may have adapted better to the pandemic than academically sponsored trials, they suggest.
“However, an important consideration is the fact that academically sponsored trials might have been more prone to disruptions during the pandemic because they can be more resource-intensive and often require research biopsies and frequent visits by patients to the clinic,” commented co-author Deborah Doroshow, MD, assistant professor of medicine at the Tisch Cancer Institute.
Manually Curated Cohort
The manually curated cohort consisted of patients with a current or past history of cancer who had an outpatient medical oncology visit at either center on the index week in March 2020. It included 2361 patients, although only 29 patients were newly enrolled in trials during the pandemic period, compared with 97 patients during the prior 3 months, the authors report.
Interestingly, among those patients who were enrolled in trials during the baseline period, non-White patients were over twice as likely to be taken off the trial during the first wave, compared with White patients (adjusted odds ratio, 2.60), the investigators observe.
This finding that more non-White patients were taken off trials during the pandemic warrants further investigation, say the researchers.
“Patients can be taken off trial due to disease progression, toxicity, or patient refusal to remain on a trial,” Labaki explained. “While keeping in mind that most patients were taken off trial due to disease progression, the fact that non-White patients appear to be taken off trial more commonly as compared to White patients parallels some of our previous findings, as part of the COVID-19 and Cancer Outcomes Study, where we identified that non-White patients were more prone to experience disruptions in cancer care, such as in-patient and telehealth oncology visits, during the pandemic,” he added.
The decline in both the numbers of patients enrolled in clinical trials as well as the number of clinical trials themselves likely reflects the strain imposed on the healthcare system as resources were diverted by the pandemic toward immediate hospital and patient needs. Nevertheless, valuable lessons were learned from the experience about how to conduct clinical trials that can be applied to clinical trials going forward, the authors comment.
“The substantial development and implementation of telehealth appointments during the COVID-19 pandemic represents a potentially important step in facilitating meetings between clinicians and patients, monitoring and follow-up,” Labaki said in a statement,
“Postal delivery of oral experimental medications may also decrease geographic barriers to clinical trial enrollment. However, it is still too early to say if this will have a significant impact on clinical trials in the normal, non-pandemic setting. We will be following this up from this summer,” he added.
No funding source for the study has been disclosed. Labaki has received research support from Genentech/ImCore.
Ann Oncol. Published online June 15, 2022. Full text
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