Evolution of the Randomized Clinical Trial in the Era of Precision Oncology.

ABSTRACT:

Importance

The randomized clinical trial (RCT) in oncology has evolved since its widespread adoption in the 1970s. In recent years, concerns have emerged regarding the use of putative surrogate end points, such as progression-free survival (PFS), and marginal effect sizes.

Objective

To describe contemporary trends in oncology RCTs and compare these findings with earlier eras of RCT design and output.

Design, setting, and participants

Retrospective cohort study of systemic therapy RCTs in breast, colorectal, and non-small cell lung cancer published in 7 major journals between 2010 and 2020. This strategy replicates prior work and allows for comparison of trends with RCTs published between 1995 to 2004 and 2005 to 2009.

Main outcomes and measures

Data on RCT desi

SUBMITTER: Del Paggio JC 

PROVIDER: S-EPMC7995135 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature