Cancer clinical trials rebound after pandemic disruptions

Clinical trials involving cancer patients were seriously disrupted by the COVID pandemic, especially during the first wave, but have slowly regained momentum and returned to pre-pandemic levels of activity, a new analysis finds.

“The good news is that patient backlogs and trial activations gradually recovered over the subsequent period of the pandemic and have now returned to above 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 assessed clinical trial activities at two major 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) , At New York. Two cohorts were used in the study: an institution-wide cohort of all new patients enrolled in cancer trials, and a smaller, manually organized cohort of patients linked to a electronic data entry.

Facility-wide cohort

“The institution-wide cohort included all new patients enrolled in oncology clinical trials at DFCI and MSSM from December 2019 to June 2021,” explain the authors. It included 4756 newly enrolled patients with a median age of 58.2 years at enrollment.

The manually organized cohort consisted of patients with a current or past history of cancer who had an outpatient medical oncology visit at either center during the index week of March 2020.

Compared to the immediate pre-pandemic period between December 2019 and February 2020, there was a 46% decrease in the number of patients newly enrolled in clinical trials during the first pandemic period from March to May 2020.

This was followed by a gradual recovery over subsequent periods of the pandemic and a return to normal levels from March to May 2021, the authors note. In fact, the number of newly enrolled patients increased by 2.7% in the last period compared to pre-pandemic levels, and a similar trend was observed at the two cancer centers, the investigators report.

Among patients newly enrolled in DFCI, there was a statistically significant increase in the proportion of new patients enrolled in industry-sponsored trials between the pre-pandemic 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 contrasts with a significant decrease in the proportion of new patients enrolled in academic-sponsored trials between the two study periods – June to August 2020 and March to May 2021. Similar to what was seen in new patients, trials Newly activated cancer surgeries at DFCI also saw a 23.6% drop at the start of the pandemic, from March to May 2020.

This was again followed by a gradual increase over the later periods of the pandemic and eventually increased by more than 30% from active trial levels before the pandemic began, the investigators note.

Industry-sponsored trials may have adapted better to the pandemic than academically-sponsored trials, they suggest.

“However, an important consideration is the fact that academic-sponsored trials might have been more prone to disruption during the pandemic as they can be more resource-intensive and often require research biopsies and frequent patient visits to the clinic. “, commented the co-author. Deborah Doroshow, MD, assistant professor of medicine at the Tisch Cancer Institute.

Manually organized cohort

The manually organized cohort consisted of patients with a current or past history of cancer who had an outpatient medical oncology visit at either center during the index week in March 2020. It included 2361 patients, although only 29 patients were newly enrolled in trials during the pandemic period, compared to 97 patients in the previous 3 months, the authors report.

Interestingly, among patients who were enrolled in trials during the baseline period, nonwhite patients were more than twice as likely to be withdrawn from the trial during the first wave, compared to white patients (adjusted odds ratio, 2.60), observe investigators. .

According to the researchers, this finding that more non-white patients were withdrawn from trials during the pandemic warrants further investigation.

“Patients can be withdrawn from the trial due to disease progression, toxicity, or the patient’s refusal to remain in a trial,” Labaki explained. “While bearing in mind that most patients were withdrawn from the trial due to disease progression, the fact that non-white patients appear to be withdrawn from the trial more frequently than white patients is consistent with to some of our previous findings, as part of the COVID-19 and Cancer Outcomes Study, where we identified that non-white patients were more likely to experience disruptions in cancer care, such as oncology visits in hospitalization and telehealth, during the pandemic,” he added.

The decline in the number of patients enrolled in clinical trials as well as the number of clinical trials themselves likely reflects the pressure placed on the healthcare system as resources have been diverted by the pandemic to the immediate needs of hospitals and patients. Nevertheless, valuable lessons have been learned from the experience on how to conduct clinical trials that can be applied to future clinical trials, the authors comment.

“The substantial development and implementation of telehealth appointments during the COVID-19 pandemic represents a potentially important step in facilitating clinician-patient encounters, monitoring and follow-up,” Labaki said in a statement. communicated,

“Mail delivery of investigational oral drugs can also reduce geographic barriers to clinical trial enrollment. However, it is still too early to tell if this will have a significant impact on clinical trials in the normal, non-pandemic setting. We will be following this since this summer,” he added.

No source of funding for the study has been disclosed. Labaki has received research support from Genentech/ImCore.

Anne Oncol. Published online June 15, 2022. Full text

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