Clinical trial analysis assesses treatment safety and efficacy following protocol waivers in refractory disease, highlighting opportunities to broaden eligibility criteria.
Although eligibility criteria are essential in trial design, overly restrictive criteria contribute to low accrual and limited generalizability. To enhance trial inclusivity, there has been growing interest in broadening eligibility criteria, especially for patients with advanced or treatment-refractory disease. Yet, the impact on patient safety remains uncertain. In the Drug Rediscovery Protocol (DRUP), protocol exceptions are frequently requested and occasionally granted. Here we describe the impact of these waivers on treatment safety and efficacy.
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Henegouwen et al. (2024) studied this question.
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