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Factors Affecting Outcomes of Craniofacial Clinical Trials
Steven Halepas1, Kevin C Lee1, Paul Nwokeji2
1Division of Oral and Maxillofacial Surgery, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY.
The Journal of Craniofacial Surgery
|October 27, 2021
Summary
Craniofacial clinical trials show high completion rates. Multicenter designs enhance trial longevity and collaboration without impacting success, suggesting a positive future for craniofacial research.
Area of Science:
- Craniofacial research
- Clinical trial methodology
- Multidisciplinary collaboration
Background:
- Cleft and craniofacial care involves complex, multidisciplinary research.
- Understanding factors influencing clinical trial success is crucial for advancing patient care.
Purpose of the Study:
- To analyze craniofacial clinical trials registered between 1999 and 2020.
- To identify key factors affecting trial completion, publication, and longevity.
Main Methods:
- Cross-sectional study of 179 craniofacial clinical trials from ClinicalTrials.gov.
- Analysis of predictor variables: funding, design, location, sites, and specialty.
- Outcomes assessed: completion, publication, and duration using regression models.
Main Results:
- High completion (82.7%) and publication (40.8%) rates observed.
- Interventional design and US location were linked to lower completion odds.
- NIH funding and multicenter design positively correlated with trial longevity.
Conclusions:
- Craniofacial trials are highly collaborative and achieve good completion rates.
- Multicenter trials improve longevity without hindering completion or publication.
- Collaboration in craniofacial research supports positive trial outcomes.
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