Most trials do not release interim summaries on the 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.
Researchers investigated the public release of early efficacy and toxicity results, during ongoing clinical studies, to better inform patients about their enrollment options.
They used simulation models of phase II glioblastoma 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.
The simulation study revealed the effects of early release of clinical trial data on key operating characteristics.
New designs of clinical studies with release of early data summaries need to consider how and when to release information, and the organizational, ethical, and statistical implications of doing so.
Implementation of permeable policies to inform physician and patient enrollment decision making will require a careful consideration of the appropriate communication of trial data, along with potential bioethical considerations of a permeable environment and the impact on trial accrual and integrity.
Solving these issues could enable investigators to better account for individual preferences of patients in clinical research.
Published: 05 February 2021
source:
https://www.nature.com/articles/s41467-021-21116-4
https://doi.org/10.1038/s41467-021-21116-4
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