We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer.
- Authors
Sarvas, Holly; Carlisle, Benjamin; Dolter, Samantha; Vinarov, Esther; Kimmelman, Jonathan
- Abstract
Precision medicine (PM) offers opportunities for reducing the costs, burdens, and time associated with drug development. We examined time, number of trials, indications tested, and patient burden needed to achieve first U.S. Food and Drug Administration license for all five novel anticancer PM drugs and all 10 novel non-PM drugs receiving U.S. Food and Drug Administration approval during 2010-2014. The 15 drug portfolios encompassed 242 trials: 87 for PM drugs and 155 for non-PM drugs. Embase and MEDLINE databases were searched for all prelicensure clinical trials, and data on time, patient numbers, indications tested, and total treatment-emergent grade 3-5 adverse events were measured from the first trial of each drug. We did not find patterns suggesting greater efficiencies in PM compared with non-PM. Gains in efficiency for PM drug development may be offset by challenges with recruitment.
- Subjects
UNITED States; DRUG development; INDIVIDUALIZED medicine; DRUG approval; CLINICAL drug trials; ANTINEOPLASTIC agents; PREVENTION of drug side effects; TUMOR treatment; THERAPEUTIC use of antineoplastic agents; EXPERIMENTAL design; RESEARCH; CLINICAL trials; RESEARCH methodology; MEDICAL care costs; MEDICAL cooperation; EVALUATION research; UNITED States. Food &; Drug Administration; COMPARATIVE studies; ORGANIZATIONAL effectiveness; RESEARCH funding; TUMORS; DRUG side effects
- Publication
JNCI: Journal of the National Cancer Institute, 2020, Vol 112, Issue 8, p859
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/djz212