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Assessing clinical trial failure risk factors and reasons in gastric cancer
Zikai Zhang1, Junyi Yin2, Yang Yue3
1Department of Science, Tongji Hospital, Tongji University School of Medicine, Shanghai, 200092, China.
Background:
Gastric cancer is one of the leading cancer-related death causes. Enormous efforts have been focused on this field in these years. However, clinical trial failure is becoming a massive obstacle for researchers to apply their research results for clinical use. This study aimed to analyze the reasons behind clinical failures and identify potential risk factors of clinical trial failures.
Methods:
On December, 1, 2021, we queried ClinicalTrials.gov for gastric cancer listed in phase II/III. We included trials specifying their interests in "stomach cancer", "Stomach Neoplasms", "Gastric Cancer", "Gastric Neoplasms", "Gastric Carcinoma", "Stomach Carcinoma", "Gastroesophageal Junction Cancer". Exclude criteria are: (1) Trials that start prior to 01/01/2007 and start after 12/01/2020; (2) Trials with "not yet recruiting", "suspended", "withdrawn", or "unknown" status; (3) Trials do not provide an anticipated accrual number or a start date.
Results:
A total of 567 trials are included. 10.2% of these trials are failed. 16 (2.82%) were terminated for good reasons, and 42 (7.41%) were terminated for bad reasons. Multi-centre (P-value = 0.088) and anticipated accrual (P-value = 0.099) are potential risk factors for clinical failures in the simple logistic regression model. After considering the interaction between multi-centre and anticipated accrual, the odds ratio of anticipated accrual is 0.60 (P-value = 0.009) in single centre trials. In multi-centre trials, the odds ratio of anticipated accrual is 0.72 (P-value = 0.025). The primary reason for gastric cancer trial terminations is recruitment failure.
Conclusion:
The rate that trials terminated in gastric cancer has decreased compared to previous studies. Comparing to other types of oncology trials, poor accrual continues to be the predominant reason, followed by business or sponsor reasons. Single-center trials with smaller anticipated accrual number are more likely to be terminated which may resulted by limited resources invested to the trial. Single-center design exacerbated the difficulty of participant recruitment. Future studies need to continue tracking the rate of trial termination across oncology and whether the reasons behind them have changed.
Insights
Gastric cancer clinical trial failures are primarily due to poor participant recruitment, especially in single-center studies. Understanding these factors can improve future trial success rates for stomach cancer research.
Area of Science:
- Oncology
- Clinical Trial Management
- Cancer Research
Background:
- Gastric cancer is a leading cause of cancer-related mortality.
- Clinical trial failures present a significant barrier to translating research findings into clinical practice.
- Identifying risk factors for trial failure is crucial for improving gastric cancer research outcomes.
Purpose of the Study:
- To analyze the reasons behind clinical trial failures in gastric cancer.
- To identify potential risk factors associated with gastric cancer clinical trial failures.
Main Methods:
- A systematic search of ClinicalTrials.gov was conducted for Phase II/III gastric cancer trials.
- Trials meeting specific inclusion criteria (e.g., date range, status, accrual data) were analyzed.
- Logistic regression was used to identify risk factors for trial termination.
Main Results:
- Out of 567 gastric cancer trials, 10.2% failed.
- Recruitment failure was the primary reason for trial termination.
- Single-center trials with lower anticipated accrual were more likely to be terminated.
Conclusions:
- Gastric cancer trial termination rates have decreased but recruitment failure remains a major issue.
- Single-center designs may exacerbate recruitment difficulties due to limited resources.
- Continued monitoring of oncology trial termination rates and reasons is recommended.
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