From registration to publication: A study on Dutch academic randomized controlled trials

Area of Science:

• Clinical Trials
• Publication Bias
• Research Integrity

Background:

• Clinical trial registration is crucial for assessing protocol adherence.
• Investigator-initiated randomized controlled trials (RCTs) are key to medical advancement.
• Ensuring transparency and accuracy in trial reporting is paramount.

Purpose of the Study:

• To evaluate publication rates and timeliness of Dutch investigator-initiated RCTs.
• To assess the consistency of published RCTs with their registered protocols.
• To identify potential gaps in clinical trial reporting and adherence.

Main Methods:

• A cohort of Dutch investigator-initiated RCTs registered between 2010-2012 was identified.
• PubMed was searched for publications until September 2016 to determine publication status and time to publication.
• Consistency of hypothesis, sample size, and primary endpoint with registry data was analyzed.

Main Results:

• Out of 168 included RCTs, 77% were published by September 2016.
• Only 39% of published RCTs reported results within two years of accrual completion.
• Consistency with the original protocol was observed in 84% for hypothesis, 55% for sample size, and 80% for primary endpoint.

Conclusions:

• A substantial proportion of Dutch investigator-initiated RCTs remain unpublished up to five years after initiation.
• Inconsistencies between published results and original trial outlines are a significant concern.
• Improvements in clinical trial design and feasibility assessment are necessary to enhance research integrity.