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Reasons why patients fail screening in Indian breast cancer trials
P Mahajan1, A Kulkarni2, S Narayanswamy1
1Department of Clinical Operations, Clininvent Research Pvt. Ltd, Mumbai, India.
Introduction:
An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment.
Materials And Methods:
We collected retrospective data of human epidermal growth factor receptor (HER2) positive Indian breast cancer patients, who failed screening for phase 3 clinical trials and ascertained their reasons for screen failure from screening logs. Statistical comparison was done to ascertain if there are any differences between private and public sites.
Results:
Of 727 patients screened at 14 sites, 408 (56.1%) failed screening. The data on the specific reasons for screen failures was not available at one of the public sites (38 screen failures out of 83 screened patients). Hence, after excluding that site, further analysis is based on 644 patients, of which 370 failed screening. Of these, 296 (80%) screen failure patients did not meet selection criteria. The majority -266 were HER2 negative. Among logistical issues, 39 patients had inadequate breast tissue sample. Sixteen patients withdrew their consent at private sites as compared to six at public sites. The difference between private and public sites for the above three reasons was statistically significant.
Conclusion:
Use of prescreening logs to reduce the number of patients not meeting selection criteria and protocol logistics, and patient counseling to reduce consent withdrawals could be used to reduce screen failure rate.
Insights
High screen failure rates in clinical trials, particularly for HER2-positive breast cancer patients, are often due to not meeting selection criteria or logistical issues. Improving prescreening and patient counseling can significantly reduce these failures.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Screen failure in clinical trials increases recruitment time and costs.
- Analyzing screen failure reasons is crucial for optimizing patient recruitment.
Purpose of the Study:
- To identify and analyze the reasons for screen failure in human epidermal growth factor receptor (HER2)-positive Indian breast cancer patients undergoing phase 3 clinical trials.
- To compare screen failure rates and reasons between private and public clinical trial sites.
Main Methods:
- Retrospective data collection from screening logs of HER2-positive Indian breast cancer patients who failed phase 3 trial screening.
- Statistical analysis to compare screen failure reasons between private and public sites.
Main Results:
- Over 56% of screened patients failed, with 80% not meeting selection criteria (predominantly HER2-negative).
- Logistical issues included inadequate tissue samples (39 patients).
- Consent withdrawals were significantly higher at private sites (16) versus public sites (6).
Conclusions:
- Implementing prescreening logs can reduce failures due to unmet criteria and logistical problems.
- Enhanced patient counseling may decrease consent withdrawals.
- Targeted interventions can improve clinical trial efficiency for breast cancer studies.
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