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DOI: 10.1055/s-0043-1777421
Evolving Barriers to Clinical Trial Enrollment and Clinical Care in Neuro-oncology in the Face of COVID-19
Abstract
The lack of treatments with durable response in neuro-oncology highlights the critical need for clinical trials to advance patient care. The intersection of relatively low incidence, evolving classification schema, and entrenched community, healthcare provider, and organizational factors have been historic challenges against successful trial enrollment and implementation. The additional need for multidisciplinary, often tertiary-level care, further magnifies latent national and international health inequities with rural and under-served populations. The COVID-19 pandemic both unveiled fundamental weaknesses in historical approaches and prompted the necessity of new approaches and systems for conducting clinical trials. Here, we provide an overview of traditional barriers to clinical trial enrollment in neuro-oncology, the effect of COVID-19 on these barriers, and the discovery of additional systemic weaknesses. Finally, we discuss future directions by reflecting on lessons learned with strategies to broaden access of care and streamline clinical trial integration into clinical practice.
Publication History
Article published online:
29 December 2023
© 2023. Thieme. All rights reserved.
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References
- 1 Sateren WB, Trimble EL, Abrams J. et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 2002; 20 (08) 2109-2117
- 2 Chang SM, Barker II FG, Schmidt MH. et al. Clinical trial participation among patients enrolled in the Glioma Outcomes Project. Cancer 2002; 94 (10) 2681-2687
- 3 Bates AJ, Couillard SA, Arons DF. et al. HOUT-15. Brain tumor patient and caregiver survey on clinical trials: identifying attitudes and barriers to patient participation. Neuro-oncol 2017; 19 (Suppl. 06) vi109
- 4 Rogers JL, Acquaye A, Vera E, Bates A, Wen PY, Armstrong TS. Provider-reported challenges and barriers to referring patients to neuro-oncology clinical trials: a report from the Society for Neuro-Oncology member survey. Neurooncol Pract 2020; 7 (01) 38-51
- 5 Lee EQ, Chukwueke UN, Hervey-Jumper SL. et al. Barriers to accrual and enrollment in brain tumor trials. Neuro-oncol 2019; 21 (09) 1100-1117
- 6 Lin D, Wang M, Chen Y. et al. Trends in intracranial glioma incidence and mortality in the United States, 1975-2018. Front Oncol 2021; 11: 748061
- 7 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin 2022; 72 (01) 7-33
- 8 Marson DC, Martin RC, Triebel KL, Nabors LB. Capacity to consent to research participation in adults with malignant glioma. J Clin Oncol 2010; 28 (24) 3844-3850
- 9 Karnofsky DA, Abelmann WH, Craver LF, Burchenal JH. The use of the nitrogen mustards in the palliative treatment of carcinoma - with particular reference to bronchogenic carcinoma. Cancer 1948; 1 (04) 634-656
- 10 Zubrod C, Schneiderman M, Frei E. et al. Appraisal of methods for the study of chemotherapy in man: comparative therapeutic trial of nitrogen mustard and thiophosphoramide. J Chronic Dis 1960; 11: 7-33
- 11 Luck AN, Preston SH, Elo IT, Stokes AC. The unequal burden of the COVID-19 pandemic: capturing racial/ethnic disparities in US cause-specific mortality. SSM Popul Health 2022; 17: 101012
- 12 Flor LS, Friedman J, Spencer CN. et al. Quantifying the effects of the COVID-19 pandemic on gender equality on health, social, and economic indicators: a comprehensive review of data from March, 2020, to September, 2021. Lancet 2022; 399 (10344): 2381-2397
- 13 Xiao H, Vaidya R, Liu F, Chang X, Xia X, Unger JM. Sex, racial, and ethnic representation in COVID-19 clinical trials: a systematic review and meta-analysis. JAMA Intern Med 2023; 183 (01) 50-60
- 14 Czeisler MÉ, Marynak K, Clarke KEN. et al. Delay or avoidance of medical care because of COVID-19-related concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep 2020; 69 (36) 1250-1257
- 15 Johnson M, Durling J, Brown CB. et al. NCOG-43. A retrospective analysis of the impact of the COVID-19 infection on neuro-oncology care and patient outcomes: a two-site study. Neuro-oncol 2022; 24 (07) vii206-vii207
- 16 Vogel MME, Wagner A, Gempt J. et al. Impact of the SARS-CoV-2 pandemic on the survival of patients with high-grade glioma and best practice recommendations. Sci Rep 2023; 13 (01) 2766
- 17 Rahman S, Majumder MA, Shaban SF. et al. Physician participation in clinical research and trials: issues and approaches. Adv Med Educ Pract 2011; 2: 85-93
- 18 Getz KA. Examining and enabling the role of health care providers as patient engagement facilitators in clinical trials. Clin Ther 2017; 39 (11) 2203-2213
- 19 Lee EQ, Selig W, Meehan C. et al. Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience. Neuro-oncol 2021; 23 (08) 1252-1260
- 20 Audisio K, Lia H, Robinson NB. et al. Impact of the COVID-19 pandemic on non-COVID-19 clinical trials. J Cardiovasc Dev Dis 2022; 9 (01) 19
- 21 Xue JZ, Smietana K, Poda P, Webster K, Yang G, Agrawal G. Clinical trial recovery from COVID-19 disruption. Nat Rev Drug Discov 2020; 19 (10) 662-663
- 22 Apostolaros M, Babaian D, Corneli A. et al. Legal, regulatory, and practical issues to consider when adopting decentralized clinical trials: recommendations from the clinical trials transformation initiative. Ther Innov Regul Sci 2020; 54 (04) 779-787
- 23 Petrini C, Mannelli C, Riva L, Gainotti S, Gussoni G. Decentralized clinical trials (DCTs): A few ethical considerations. Front Public Health 2022; 10: 1081150 DOI: 10.3389/fpubh.2022.1081150.
- 24 Dorsey ER, Kluger B, Lipset CH. The new normal in clinical trials: decentralized studies. Ann Neurol 2020; 88 (05) 863-866
- 25 Curtis A, Qu Y. Impact of using a mixed data collection modality on statistical inferences in decentralized clinical trials. Ther Innov Regul Sci 2022; 56 (05) 744-752
- 26 Rogers A, De Paoli G, Subbarayan S. et al; Trials@Home Consortium. A systematic review of methods used to conduct decentralised clinical trials. Br J Clin Pharmacol 2022; 88 (06) 2843-2862