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Registration of randomized clinical trials--a challenge
R M Østervig1, A Sonne1, L S Rasmussen1
1Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Acta Anaesthesiologica Scandinavica
|June 25, 2015
Summary
Journal adherence to clinical trial registration improved significantly after Acta Anaesthesiologica Scandinavica mandated registration for randomized controlled trials (RCTs). This policy enhanced the accuracy of trial registration, boosting compliance rates.
Area of Science:
- Medical Research Ethics
- Clinical Trial Management
- Scientific Publication Standards
Background:
- The Declaration of Helsinki mandates interventional study registration, yet consistent implementation by journals remains a challenge.
- Acta Anaesthesiologica Scandinavica (Acta) has required registration for studies initiated after January 1, 2010.
- Assessing compliance with registration policies is crucial for scientific integrity.
Purpose of the Study:
- To evaluate the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014.
- To determine the impact of Acta's registration policy on the quality of trial reporting.
- To identify trends in clinical trial registration practices.
Main Methods:
- Manual search of Acta issues published between 2009 and 2014 to identify RCTs.
- Extraction of data on patient enrollment timing and trial registry status.
- Classification of RCTs based on whether patient enrollment began after registration.
Main Results:
- A total of 200 RCTs were identified and analyzed.
- Patient enrollment dates were unspecified for 25.5% of the studies.
- The rate of correctly registered trials significantly increased from 17.1% before 2010 to 63.2% after the policy implementation (P < 0.01).
- ClinicalTrials.gov was the primary registry used for most trials.
Conclusions:
- While initial registration compliance was low, Acta's mandatory registration policy led to a substantial improvement in correctly registered randomized controlled trials.
- The findings underscore the effectiveness of journal policies in promoting ethical research practices.
- Continued monitoring of trial registration is essential for maintaining research transparency.
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