An Overview of Phase 2 Clinical Trial Designs.
Int J Radiat Oncol Biol Phys
; 112(1): 22-29, 2022 01 01.
Article
in En
| MEDLINE
| ID: mdl-34363901
ABSTRACT
Clinical trials are studies to test new treatments in humans. Typically, these treatments are evaluated over several phases to assess their safety and efficacy. Phase 1 trials are designed to evaluate the safety and tolerability of a new treatment, typically with a small number of patients (eg, 20-80), generally spread across several dose levels. Phase 2 trials are designed to determine whether the new treatment has sufficiently promising efficacy to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety. These studies usually involve a few hundred patients. This article provides an overview of some of the most commonly used phase 2 designs for clinical trials and emphasizes their critical elements and considerations. Key references to some of the most commonly used phase 2 designs are given to allow the reader to explore in more detail the critical aspects when planning a phase 2 trial. A comparison of 3 potential designs in the context of the NRG-HN002 trial is presented to complement the discussion about phase 2 trials.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Research Design
/
Clinical Trials, Phase II as Topic
Type of study:
Clinical_trials
Limits:
Humans
Language:
En
Journal:
Int J Radiat Oncol Biol Phys
Year:
2022
Type:
Article