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An Overview of Phase 2 Clinical Trial Designs.
Torres-Saavedra, Pedro A; Winter, Kathryn A.
Affiliation
  • Torres-Saavedra PA; NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania. Electronic address: torresp@nrgoncology.org.
  • Winter KA; NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.
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.
Subject(s)

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

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