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Transitional dynamics in oncology clinical trials: evaluating the impact of Clinical Trials Act on cooperative groups
Kenichi Nakamura1, Koji Takeda2, Akiko M Saito3
1Japan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
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 to 26 trials in fiscal year 2018, surged to 50 trials in fiscal year 2019, but then gradually decreased to 25 trials by fiscal year 2022. Specified clinical trials decreased from 32 trials in fiscal year 2019 to 12 trials in fiscal year 2022. The number of ongoing trials was 220 trials in 2018, peaked at 245 trials in 2020, but then gradually decreased to 219 trials by 2023. The number of specified clinical trials has been in consistent decline. By April 2023, of the 20 ongoing non-specified clinical trials, nine adhered to Clinical Trials Act and 11 followed the Ethical Guidelines for Medical and Health Research Involving Human Subjects.
Conclusion:
the number of multicentre clinical trials in oncology gradually decreased after the Clinical Trials Act's enforcement, which underscores the need for comprehensive amendment of the Clinical Trials Act to streamline the operational process.
Insights
The Clinical Trials Act in Japan increased operational burdens, leading to a gradual decline in new and ongoing oncology clinical trials. Amendments are needed to streamline processes and support cooperative cancer research groups.
Area of Science:
- Oncology
- Clinical Trials Research
- Regulatory Science
Background:
- Large-scale multicentre clinical trials are crucial for establishing standard cancer treatments.
- The Clinical Trials Act was enforced in Japan on April 1, 2018, significantly impacting trial operations.
- The long-term effects of this act on cancer cooperative groups remained unclear.
Purpose of the Study:
- To assess the impact of the Clinical Trials Act on Japanese cancer cooperative groups.
- To analyze trends in newly initiated and ongoing clinical trials before and after the act's enforcement.
Main Methods:
- A survey was conducted across nine major Japanese cancer cooperative groups.
- Data on newly initiated trials (FY2017-2022) and ongoing trials (2018-2023) were collected.
- The impact was evaluated by comparing trial numbers pre- and post-Clinical Trials Act implementation.
Main Results:
- Newly initiated trials initially dropped, then surged, but ultimately decreased by FY2022.
- Specified clinical trials showed a consistent decline from FY2019 to FY2022.
- The number of ongoing trials peaked in 2020 before gradually decreasing by 2023.
Conclusions:
- The enforcement of the Clinical Trials Act correlated with a gradual decrease in multicentre oncology clinical trials.
- There is a need for comprehensive amendments to the Clinical Trials Act to simplify operational procedures.
- Streamlining the act is essential for the continued success of cooperative cancer research.
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