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Multicenter Study
. 2022 Aug;33(8):836-844.
doi: 10.1016/j.annonc.2022.04.071. Epub 2022 Jun 14.

Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study

Z Bakouny  1 , C Labaki  1 , S Bhalla  2 , A L Schmidt  1 , J A Steinharter  1 , J Cocco  2 , D A Tremblay  2 , M M Awad  1 , A Kessler  2 , R I Haddad  1 , M Evans  3 , F Busser  1 , M Wotman  3 , C R Curran  1 , B S Zimmerman  2 , G Bouchard  1 , T Jun  2 , P V Nuzzo  1 , Q Qin  2 , L Hirsch  1 , J Feld  2 , K M Kelleher  1 , D Seidman  2 , H Huang  2 , H M Anderson-Keightly  2 , T El Zarif  1 , S Abou Alaiwi  1 , C Champagne  1 , T D Rosenbloom  2 , P S Stewart  2 , B E Johnson  1 , Q Trinh  4 , S M Tolaney  1 , M D Galsky  2 , T K Choueiri  5 , D B Doroshow  6
Affiliations
Multicenter Study

Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study

Z Bakouny et al. Ann Oncol. 2022 Aug.

Abstract

Background: COVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct.

Patients and methods: This prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States between December 2019 and June 2021. The primary objective was to assess the enrollment on, accrual to, and activation of oncology therapeutic clinical trials during the pandemic using an institution-wide cohort of (i) new patient accruals to oncological trials, (ii) a manually curated cohort of patients with cancer, and (ii) a dataset of new trial activations.

Results: The institution-wide cohort included 4756 new patients enrolled to clinical trials from December 2019 to June 2021. A major decrease in the numbers of new patient accruals (-46%) was seen early in the pandemic, followed by a progressive recovery and return to higher-than-normal levels (+2.6%). A similar pattern (from -23.6% to +30.4%) was observed among 467 newly activated trials from June 2019 to June 2021. A more pronounced decline in new accruals was seen among academically sponsored trials (versus industry sponsored trials) (P < 0.05). In the manually curated cohort, which included 2361 patients with cancer, non-white patients tended to be more likely taken off trial in the early pandemic period (adjusted odds ratio: 2.60; 95% confidence interval 1.00-6.63), and substantial pandemic-related deviations were recorded.

Conclusions: Substantial disruptions in clinical trial activities were observed early during the pandemic, with a gradual recovery during ensuing time periods, both from an enrollment and an activation standpoint. The observed decline was more prominent among academically sponsored trials, and racial disparities were seen among people taken off trial.

Keywords: COVID-19; cancer; clinical trials.

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Conflict of interest statement

Disclosure The authors report the following conflicts of interest: ZB non-financial support, Bristol Myers Squibb (BMS); research support, Genentech/imCore. Honoraria from UpToDate. CL research support, Genentech/imCore. AS educational travel support, Pfizer and Astellas. MMA research support, BMS Lilly, AstraZeneca, and Genentech; consulting/advisory role, BMS, Lilly, AstraZeneca, Genentech, Merck, Achilles, and Abbvie. RH consulting/advisory role, BMS, Merck, Pfizer, Genetech, AstraZeneca, and GSK; research grant/funding, Merck, BMS, Pfizer, Genentech, GSK, and AstraZeneca. ST institutional research funding from AstraZeneca, Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics, Exelixis, BMS, Eisai, Nanostring, Cyclacel, Odonate, and Seattle Genetics; has served as an advisor/consultant to AstraZeneca, Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics, BMS, Eisai, Nanostring, Puma, Sanofi, Celldex, Paxman, Puma, Silverback Therapeutics, G1 Therapeutics, AbbVie, Athenex, OncoPep, Outcomes4Me, Kyowa Kirin Pharmaceuticals, Daiichi-Sankyo, and Samsung Bioepsis Inc. MDG reports: Stock, Rappta Therapeutics; consulting/advisory role, BioMotiv, Janssen, Dendreon, Merck, GlaxoSmithKline, Lilly, Astellas, Genentech, BMS, Novartis, Pfizer, EMD Serono, AstraZeneca, Seattle Genetics, Incyte, Alleron Therapeutics, Dracen, Inovio Pharmaceuticals, Numab, Dragonfly Therapeutics; institutional research funding, Janssen, Dendreon, Novartis, Bristol-Myers Squibb, Merck, AstraZeneca, Genentech/Roche. TKC research support, AstraZeneca, Alexion, Bayer, BMS/ER Squibb and sons LLC, Cerulean, Eisai, Foundation Medicine Inc., Exelixis, Ipsen, Tracon, Genentech, Roche, Roche Products Limited, F. Hoffmann-La Roche, GlaxoSmithKline, Lilly, Merck, Novartis, Peloton, Pfizer, Prometheus Labs, Corvus, Calithera, Analysis Group, Sanofi/Aventis, Takeda; honoraria, AstraZeneca, Alexion, Sanofi/Aventis, Bayer, BMS/ER Squibb and sons LLC, Cerulean, Eisai, Foundation Medicine Inc., Exelixis, Genentech, Roche, Roche Products Limited, F. Hoffmann-La Roche, GlaxoSmithKline, Merck, Novartis, Peloton, Pfizer, EMD Serono, Prometheus Labs, Corvus, Ipsen, Up-to-Date, NCCN, Analysis Group, NCCN, Michael J. Hennessy (MJH) Associates, Inc. (Healthcare Communications Company with several brands such as OnClive, PeerView and PER), Research to Practice, L-path, Kidney Cancer Journal, Clinical Care Options, Platform Q, Navinata Healthcare, Harborside Press, American Society of Medical Oncology, NEJM, Lancet Oncology, Heron Therapeutics, Lilly Oncology; consulting or advisory role, AstraZeneca, Alexion, Sanofi/Aventis, Bayer, BMS/ER Squibb and sons LLC, Cerulean, Eisai, Foundation Medicine Inc., Exelixis, Genentech, Heron Therapeutics, Lilly, Roche, GlaxoSmithKline, Merck, Novartis, Peloton, Pfizer, EMD Serono, Prometheus Labs, Corvus, Ipsen, Up-to-Date, NCCN, Analysis Group, Pionyr, Tempest, Lilly Ventures; Stocks: Pionyr, Osel, and Tempest; leadership role, Director of Genitourinary Oncology Division at Dana-Farber and past President of Medical Staff at Dana-Farber, member of NCCN Kidney panel and the GU Steering Committee, past chairman of the Kidney Cancer Association Medical and Scientific Steering Committee, KidneyCan Advisory board, Kidney cancer Research Summit co-chair (2019-); patents, royalties or other intellectual properties related to checkpoint inhibitors biomarkers and ctDNA (no royalties made as to date); travel, accommodations, expenses, in relation to consulting, advisory roles, or honoraria; medical writing and editorial assistance support may have been funded by Communications companies funded by pharmaceutical companies (ClinicalThinking, Envision Pharma Group, Fishawack Group of Companies, Health Interactions, Parexel, Oxford PharmaGenesis, and others). TKC’s institution (Dana-Farber Cancer Institute) may have received additional independent funding of drug companies or/and royalties potentially involved in research around the subject matter. TKC has mentored several non-US citizens on research projects with potential funding (in part) from non-US sources/Foreign Components. DD Consulting/Advisory role, Mirati, Ipsen, Boehringer Ingelheim, Atheneum Partners, Boston Healthcare Associates, Dedham Group, Guidepoint Global Advisors; travel expenses, Ipsen. All other authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
(A) Flowchart representing the number of new patient accruals to oncological trials in the institution-wide cohort from DFCI and MSSM, with available patient- and trial-related variables. (B) Flowchart representing the number of newly activated trials included in the clinical trial dataset from DFCI. (C) Flowchart representing the number of patients included from DFCI and MSSM in the manually curated cohort, with numbers of patients excluded with exclusion criteria, patients included in the analysis, and the number of patients who were on trial at any point during the study. DFCI, Dana-Farber Cancer Institute; MSSM, Mount Sinai School of Medicine.
Figure 2
Figure 2
Donut plot representing the distribution by cancer type of all patients newly enrolled to oncological clinical trials across all DFCI (n = 4071). GI, gastrointestinal; GU, genitourinary; H&N, head and neck; Heme, Hematologic.
Figure 3
Figure 3
(A) Bar plot representing the number of newly enrolled patients to oncological clinical trials at the institution-wide level at DFCI and MSSM, across the different time periods (3-month intervals). (B) Racial distribution of newly enrolled patients to oncological clinical trials in the institution-wide cohort at DFCI during the studied time periods. (C) Age distribution among newly enrolled patients at DFCI (institution-wide level) during the different time periods, with pairwise comparisons (using Mann–Whitney U test). Only selected pairwise comparisons are shown in the figure, though all pairwise comparisons had P > 0.05. DFCI, Dana-Farber Cancer Institute; MSSM, Mount Sinai School of Medicine.
Figure 4
Figure 4
Bar plot representing (A) the numbers and (B) the percentages of newly enrolled patients at the institution-wide level at DFCI according to trial categories (i.e. sponsor type). DFCI, Dana-Farber Cancer Institute.
Figure 5
Figure 5
Bar plot representing the numbers of new activated trials across DFCI during the different time periods from June 2019 to May 2021. DFCI, Dana-Farber Cancer Institute.
Figure 6
Figure 6
(A) Pie charts representing the breakdown of race and ethnicity by clinical trial participation group in the manually curated cohort (n = 332). (B) Stacked bar plot representing clinical trial deviations during the baseline and pandemic periods (P value from Fisher’s exact test for deviation versus no deviation reported) in the manually curated cohort (n = 332). (C) Stacked bar plot representing clinical trial serious adverse events during the baseline and pandemic periods (P value from Fisher’s exact test for deviation versus no deviation reported) in the manually curated cohort (n = 332). The baseline period was defined as the pre-pandemic period from December 2019 to March 2020. The pandemic period was defined as the first peak of the pandemic of the Northeastern United States from March to June 2020. SAE, serious adverse event.
Supplementary Figure S1
Supplementary Figure S1
Supplementary Figure S2
Supplementary Figure S2
Supplementary Figure S3
Supplementary Figure S3
See this image and copyright information in PMC

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