The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies
In the last few years, numerous novel designs have been proposed to improve the efficiency and accuracy of phase I trials to identify the maximum-tolerated dose (MTD) or the optimal biological dose (OBD) for noncytotoxic agents. However, the conventional 3+3 approach, known for its and poor performance, continues to be …