CLINICAL DEVELOPMENT IN ONCOLOGY
More Narrowly Defined Target Patient Populations Contributing to Protocol Amendments in Oncology Clinical Trials
EMILY BOTTO, ZACHARY SMITH, KENNETH GETZ, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, TUFTS UNIVERSITY SCHOOL OF MEDICINE
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nvestigational therapies targeting cancer-related diseases have long dominated drug development pipelines,
but recent years have seen an exponential increase in the number of clinical trials in oncology. Nearly one-out-of-four (23%) of drugs in development targeted cancer- related diseases in 2020. Increase in global cancer incidence, better knowledge of biological mechanisms, high disease burden, and high unmet medical need all contribute to the significant hold oncology has on the drug development pipeline despite the therapeutic area’s low success rate and high development costs. This low success rate – estimated at 3.5% in 2022 – may be at least partially caused by
narrower patient populations in oncology relative to non-oncology trials, which is further exacerbated by the rise of precision medicine (Wong, 2019). As the defined patient population narrows, the difficulty of recruiting eligible participants intensifies, resulting in longer recruitment periods and higher probability of termination due to insufficient accrual. Difficulty in recruiting patients can result in an amendment to adjust the sample size or expand the eligibility criteria, which further extends the duration of the trial. Tufts CSDD collected protocol and amendment data from 950 protocols and 2,188 amendments among a working group of 22 pharmaceutical, biotechnology, and clinical research organizations in 2022. In this study,
Source: Tufts CSDD 6 | Clinical Trials in Oncology
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