Clinical research—the trials and their findings—has become more transparent since the development in the early 2000s of clinical trial registries. These trials allow the public to follow trial progress on a registry website including recruitment, changes to the original protocol, and ideally the findings. But a 2016 report found that the overall rate of results reporting of ALL clinical trials ranges from 4.1% to 55.4%, meaning nearly half of clinical trials never publicly report their findings. In this recent study, the authors sought to analyze possible risk factors that can lead to discrepancies between the original trial registry and published results.
In looking at over 157 foot and ankle surgery-related randomized controlled trials registered with ClinicalTrials.gov (the largest data base in the United States and required for FDA approval), they found that 67.5% of trials were registered, with 46.5% funded by industry. Only 54.8% of trials reported being complete, and only 42% had their findings published in a peer-reviewed journal. The researchers identified a variety of discrepancies:
- 5% primary outcome
- 6% sample size
- 8% follow-up time
- 4% inclusion/exclusion criteria
Industry-funded trials saw significantly higher discrepancies in sample size and inclusion/exclusion criteria (P =0.024). Positive outcomes were more frequently reported in industry-funded trials (P =0.011), indicating a risk of bias in assessments.
Source: Karaismailoglu B, et al. Characteristics and publication discrepancies of foot & ankle surgery-related clinical trials. Foot Ankle Surg. 2021;S1268-7731(21)00184-3. doi: 10.1016/j.fas.2021.09.003.