Inadequate Dissemination of Phase I Trials
Author Information
Author(s): Decullier Evelyne, Chan An-Wen, Chapuis François
Primary Institution: Hospices Civils de Lyon
Hypothesis
Are the results of Phase I trials adequately disseminated compared to Phase II–IV trials?
Conclusion
Phase I trials are less frequently published than other types of trials, indicating inadequate dissemination of their results.
Supporting Evidence
- Phase I trials were more likely to be initiated and completed than Phase II–IV trials.
- Only 17% of Phase I studies were published compared to 43% of Phase II–IV studies.
- Confidentiality was the main reason for nonpublication of Phase I studies.
Takeaway
This study found that early drug trials (Phase I) are often not shared with the public, which is important for safety and knowledge.
Methodology
The study reviewed protocols of drug trials approved by ethics committees in France and analyzed responses from principal investigators regarding trial initiation, completion, and publication.
Potential Biases
Nonresponders may have had trials that were not initiated, not completed, or unpublished, potentially overstating publication rates.
Limitations
The response rate was 67%, which may introduce bias, and publication status was not verified in databases.
Participant Demographics
The trials included both healthy volunteers and patients, but specific demographics were not detailed.
Statistical Information
P-Value
p<0.0001
Confidence Interval
0.14–0.41
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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