Pharmacogenomics in early-phase clinical development.
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Pharmacogenomics (PGx) offers the promise of utilizing genetic fingerprints to predict individual responses to drugs in terms of safety, efficacy and pharmacokinetics. Early-phase clinical trial PGx applications can identify human genome variations that are meaningful to study design, selection of participants, allocation of resources and clinical research ethics. Results can inform later-phase study design and pipeline developmental decisions. Nevertheless, our review of the clinicaltrials.gov database demonstrates that PGx is rarely used by drug developers. Of the total 323 trials that included PGx as an outcome, 80% have been conducted by academic institutions after initial regulatory approval. Barriers for the application of PGx are discussed. We propose a framework for the role of PGx in early-phase drug development and recommend PGx be universally considered in study design, result interpretation and hypothesis generation for later-phase studies, but PGx results from underpowered studies should not be used by themselves to terminate drug-development programs.
Clinical Trials as Topic
Dose-Response Relationship, Drug
Genome-Wide Association Study
Polymorphism, Single Nucleotide
Published Version (Please cite this version)10.2217/pgs.13.81
Publication InfoBurt, Tal; & Dhillon, Savita (2013). Pharmacogenomics in early-phase clinical development. Pharmacogenomics, 14(9). pp. 1085-1097. 10.2217/pgs.13.81. Retrieved from https://hdl.handle.net/10161/9359.
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Assistant Professor of Psychiatry and Behavioral Sciences
Tal Burt, MD is a Board-Certified psychiatrist and clinical researcher trained in Israel, Italy, France, and the United States. After joining the faculty at the Department of Psychiatry at Columbia University, Dr. Burt joined Pfizer Inc., and then Eisai Pharmaceuticals, as Senior Medical Director with responsibilities in all phases of clinical research and development. He then joined Duke and was the founding director of the Investigational Medicine Unit (IMU) in Singapore and th
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