The COVID-19 pandemic substantially disrupted clinical trial activities in oncology, but enrollment and activation have both begun to bounce back, according to a prospective study of therapeutic clinical trials conducted at two large academic medical centers. The research team, which included investigators from the Brigham, found a major decrease (46 percent) in patient accruals early in the pandemic. But the team also reported a progressive recovery and a return-to-higher than normal levels by June 2021. From 2019 to June 2021, the two centers studied had added 467 newly activated clinical trials. The authors note that the sharpest decline in enrollment during the pandemic was seen among academically sponsored trials, and racial disparities were seen among people taken off trial.
“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,” said co-first author Ziad Bakouny, MD, an internal medicine resident at the Brigham.
Read more in Annals of Oncology.
Journal
Cancer Cell
DOI
10.1016/j.ccell.2020.10.023
Method of Research
Observational study
Subject of Research
People
Article Title
Cancer Care Disparities during the COVID-19 Pandemic: COVID-19 and Cancer Outcomes Study
Article Publication Date
15-Jun-2022
COI Statement
The authors report the following conflicts of interest: A.L.S., educational travel support from Pfizer and Astellas; Z.B., non-financial support from Bristol Myers Squibb and research support from Genentech/ImCore; M.M.A., research support from Bristol-Myers Squibb Lilly, AstraZeneca, and Genentech and a consulting/advisory role with Bristol-Myers Squibb, Lilly, AstraZeneca, Genentech, Merck, Achilles, and Abbvie; R.I.H., consulting/advisory role with BMS, Merck, Pfizer, Genetech, Astra Zeneca, and GSK and research grant/funding from Merck, BMS, Pfizer, Genentech, GSK, and Astra Zeneca. M.D.G. reports stock from Rappta Therapeutics; a consulting/advisory role for BioMotiv, Janssen, Dendreon, Merck, GlaxoSmithKline, Lilly, Astellas, Genentech, Bristol-Myers Squibb, Novartis, Pfizer, EMD Serono, AstraZeneca, Seattle Genetics, Incyte, Alleron Therapeutics, Dracen, Inovio Pharmaceuticals, NuMab, and Dragonfly Therapeutics; and institutional research funding from Janssen, Dendreon, Novartis, Bristol-Myers Squibb, Merck, AstraZeneca, and Genentech/Roche. T.K.C. reports research support from AstraZeneca, Alexion, Bayer, Bristol MyersSquibb/ER Squibb and sons LLC, Cerulean, Eisai, Foundation Medicine Inc., Exelixis, Ipsen, 16 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, Bristol Myers-Squibb/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; a consulting or advisory role for AstraZeneca, Alexion, Sanofi/Aventis, Bayer, Bristol Myers-Squibb/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; owns stocks of Pionyr and Tempest; leadership roles as 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–present); patents, royalties, or other intellectual properties including International Patent Application No. PCT/US2018/12209, entitled “PBRM1 Biomarkers Predictive of Anti-Immune Checkpoint Response,” filed January 3, 2018, claiming priority to U.S. Provisional Patent Application 17 No. 62/445,094, filed January 11, 2017; International Patent Application No. PCT/US2018/058430, entitled “Biomarkers of Clinical Response and Benefit to Immune Checkpoint Inhibitor Therapy,” filed October 31, 2018, claiming priority to U.S. Provisional Patent Application No. 62/581,175, filed November 3, 2017; and travel, accommodations, and 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). T.K.C.’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. T.K.C. has mentored several non-US citizens on research projects with potential funding (in part) from non-US sources/foreign components. D.B.D. reports consulting/advisory roles with Ipsen, Boeringer Ingelheim, Atheneum Partners, Boston Healthcare Associates, Dedham Group, and Guidepoint Global Advisors and travel expenses from Ipsen.
