Burn clinical trials: A systematic review of registration and publications

Abstract

Background: Randomized controlled clinical trials (CTs) are gold standard tools for assessing interventions. Although burn CTs have improved care, their status, publication frequency, and publication quality are not known.

Objectives: (1) Characterize burn CTs by analyzing location, completion status, temporal trend, and funding sources. (2) Assess quality of trial reporting.

Data sources: CT records were obtained from ClinicalTrials.gov and WHO's CT Registry (searched May 2017). Publications were obtained from PubMed, Google Scholar, OVID MEDLINE, and ClinicalTrials.gov (searched June 2017).

Publication appraisal: 23-item rubric adapted from CONSORT and ICH E3 guidelines.

Results: 738 burn CTs were identified globally, of which majority were publically-funded (77%), ongoing (52%), and assessed behavioral, pharmacological, device-based, dietary-based, and biological/procedural interventions. Amongst the ended trials, 69 (28%) published their findings. Significantly fewer industry-funded trials published findings (14% vs 33% publically-funded). Quality of reporting was suboptimal, and most underreported categories were trial phase, severity, and sample size estimation.

Limitations: Incomplete, outdated, and non-registered CTs which are difficult to track.

Conclusions: Burn trials are proliferating in number, location, and interventions assessed. Only a small proportion are published and quality of reporting is suboptimal.

Implications of key findings: Burn researchers should aim to register and report on all clinical trials regardless of outcome. Superior a priori design can reduce precocious termination and mandatory reporting of data fields can improve quality of reporting. Systematic review registration number: CRD42017068549.

Keywords: Burns; Clinical trial; Industry; Publication quality; Trial termination.