Abstract
AbstractMost trials do not release interim summaries on efficacy and toxicity of the experimental treatments being tested, with this information only released to the public after the trial has ended. While early release of clinical trial data to physicians and patients can inform enrollment decision making, it may also affect key operating characteristics of the trial, statistical validity and trial duration. We investigate the public release of early efficacy and toxicity results, during ongoing clinical studies, to better inform patients about their enrollment options. We use simulation models of phase II glioblastoma (GBM) clinical trials in which early efficacy and toxicity estimates are periodically released accordingly to a pre-specified protocol. Patients can use the reported interim efficacy and toxicity information, with the support of physicians, to decide which trial to enroll in. We describe potential effects on various operating characteristics, including the study duration, selection bias and power.
Publisher
Springer Science and Business Media LLC
Subject
General Physics and Astronomy,General Biochemistry, Genetics and Molecular Biology,General Chemistry
Reference38 articles.
1. Murthy, V. H., Krumholz, H. M. & Gross, C. P. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. J. Am. Med. Assoc. 291, 2720–2726 (2004).
2. Rogers, J. L. et al. Provider-reported challenges and barriers to referring patients to neuro-oncology clinical trials: a report from the Society for Neuro-Oncology member survey. Neuro-Oncol. Pract. 7, 38–51 (2020).
3. Lee, E. Q. et al. Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients. Neuro-Oncol. 22, 601–612 (2020).
4. Madsen, S. M., Holm, S. & Riis, P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a grounded theory approach. J. Med. Ethics 33, 234–240 (2007).
5. Grunfeld, E., Zitzelsberger, L., Coristine, M. & Aspelund, F. Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer 95, 1577–1583 (2002).
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