Transitional dynamics in oncology clinical trials: evaluating the impact of Clinical Trials Act on cooperative groups.

ABSTRACT:

Objective

large-scale multicentre clinical trials conducted by cooperative groups have generated a lot of evidence to establish better standard treatments. The Clinical Trials Act was enforced on 1 April 2018, in Japan, and it has remarkably increased the operational burden on investigators, but its long-term impact on cancer cooperative groups is unknown.

Methods

a survey was conducted across the nine major cooperative groups that constitute the Japan Cancer Trials Network to assess the impact of Clinical Trials Act on the number of newly initiated trials from fiscal year (from 1 April to 31 March) 2017 to 2022 and that of ongoing trials on 1 April in each year from 2018 to 2023.

Results

the number of newly initiated trials dropped from 38 trials in fiscal year 2017

SUBMITTER: Nakamura K 

PROVIDER: S-EPMC11228844 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature