New clinical trial design in precision medicine: discovery, development and direction

New clinical trial design in precision medicine: discovery, development and direction

04 March 2024 | Xiao-Peng Duan, Bao-Dong Qin, Xiao-Dong Jiao, Ke Liu, Zhan Wang and Yuan-Sheng Zang
The article reviews the development and application of new clinical trial designs—basket, umbrella, and platform trials—in the era of precision medicine. These designs are designed to address the significant heterogeneity among patients with specific diseases by providing personalized therapy based on biomarkers. The basket trial evaluates the efficacy of a drug or intervention across multiple diseases or tissue types sharing a common therapeutic target. The umbrella trial assesses multiple interventions within a single disease, stratifying patients based on molecular subgroups. The platform trial is a flexible, adaptive design that allows for the continuous evaluation and optimization of interventions based on accumulating evidence. The article highlights the advantages of these trial designs, such as increased efficiency, resource optimization, and dynamic adaptation to emerging scientific knowledge. It also discusses the clinical achievements and future directions of these trial designs, emphasizing their potential to enhance the innovation and feasibility of clinical trials in precision medicine.The article reviews the development and application of new clinical trial designs—basket, umbrella, and platform trials—in the era of precision medicine. These designs are designed to address the significant heterogeneity among patients with specific diseases by providing personalized therapy based on biomarkers. The basket trial evaluates the efficacy of a drug or intervention across multiple diseases or tissue types sharing a common therapeutic target. The umbrella trial assesses multiple interventions within a single disease, stratifying patients based on molecular subgroups. The platform trial is a flexible, adaptive design that allows for the continuous evaluation and optimization of interventions based on accumulating evidence. The article highlights the advantages of these trial designs, such as increased efficiency, resource optimization, and dynamic adaptation to emerging scientific knowledge. It also discusses the clinical achievements and future directions of these trial designs, emphasizing their potential to enhance the innovation and feasibility of clinical trials in precision medicine.
Reach us at info@study.space
[slides and audio] New clinical trial design in precision medicine%3A discovery%2C development and direction