TY - JOUR
KW - adaptive design
KW - biomarker studies
KW - false discovery rate
KW - multiplicity problem
KW - phase II clinical trials
AU - Gail A. Van Norman
AB - Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.
BT - JACC: Basic to Translational Science
DA - 2019-06-01
DO - 10.1016/j.jacbts.2019.02.005
IS - 3
N2 - Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.
PY - 2019
SP - 428
EP - 437
T2 - JACC: Basic to Translational Science
TI - Phase II Trials in Drug Development and Adaptive Trial Design
UR - https://www.sciencedirect.com/science/article/pii/S2452302X19300658
VL - 4
Y2 - 2026-01-07
SN - 2452-302X
ER -