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Funding, disease area, and internal validity of hepatobiliary randomized clinical trials
Lise Lotte Kjaergard1, Christian Gluud
1The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark.
Insights
External funding and disease area significantly impact the internal validity of hepatobiliary randomized clinical trials, influencing methodological quality and sample size. Unfunded trials showed lower quality in allocation sequence generation and blinding.
Area of Science:
- Hepatobiliary research
- Clinical trial methodology
- Medical research funding
Background:
- Assessing the internal validity of clinical trials is crucial for reliable results.
- Funding sources and specific disease areas may influence trial quality.
- Previous research has not comprehensively evaluated these factors in hepatobiliary trials.
Purpose of the Study:
- To determine if funding and disease area are associated with the internal validity of hepatobiliary randomized clinical trials.
- To investigate the relationship between funding (profit, nonprofit, none) and methodological quality (randomization, blinding, allocation concealment, sample size).
- To examine how different disease areas within hepatobiliary research affect trial quality.
Main Methods:
- A systematic review of 616 hepatobiliary randomized clinical trials published between 1985 and 1996.
- Data extraction included funding source, disease area, randomization adequacy, double blinding, allocation concealment, and sample size.
- Statistical analysis was performed to assess associations between funding, disease area, and internal validity metrics.
Main Results:
- External funding (profit or nonprofit) was linked to better methodological quality, specifically in allocation sequence generation and double blinding, compared to unfunded trials.
- No significant difference in internal validity was found between trials funded by profit versus nonprofit organizations.
- Disease area significantly influenced methodological quality and sample size, independent of funding status.
Conclusions:
- External funding is a significant predictor of adequate methodological quality in hepatobiliary randomized clinical trials.
- The specific disease area within hepatobiliary research is also a significant predictor of both methodological quality and sample size.
- Both funding and disease area are critical factors influencing the internal validity of these trials.
Objective:
The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials.
Methods:
We gathered data on funding, disease area, methodological quality (randomization and double blinding), and sample size from 616 hepatobiliary randomized clinical trials published from 1985 to 1996 in 12 MEDLINE indexed journals.
Results:
The internal validity (methodological quality and sample size) of trials funded by profit or nonprofit organizations was not significantly different. Compared with these trials, trials without funding were significantly less likely to report adequate generation of the allocation sequence (55% vs 41%, p = 0.001) and to be double blind (42% vs 25%, p < 0.001), but the proportion with adequate allocation concealment and the sample size were not significantly different. The trials covered 12 disease areas. The proportion of funded trials did not differ significantly in different disease areas. The disease area was significantly associated with the proportion of trials with adequate generation of the allocation sequence (p < 0.001), allocation concealment (p = 0.003), and double blinding (p < 0.001) as well as the sample size (p < 0.001). This association was not explained by the proportion of trials with funding.
Conclusions:
External funding was significantly associated with adequate methodological quality, but not with the sample size. Irrespective of funding, the disease area was significantly associated with the methodological quality and sample size. Accordingly, external funding and the disease area are significant predictors of the internal validity of hepatobiliary randomized clinical trials.