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Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods
Published on: September 19, 2012
The uncertainty principle and industry-sponsored research
B Djulbegovic1, M Lacevic, A Cantor
1Division of Blood and Bone Marrow Transplantation, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA. djulbebm@moffitt.usf.edu
Lancet (London, England)
|September 1, 2000
Summary
Pharmaceutical industry funding of clinical trials may introduce bias. Non-profit funded studies better uphold the uncertainty principle, ensuring fairer comparisons of treatments.
Area of Science:
- Clinical Trials Methodology
- Medical Research Ethics
- Pharmaceutical Industry Oversight
Background:
- Pharmaceutical industry-sponsored randomized clinical trials (RCTs) face scrutiny for potential bias.
- Bias can arise from selective reporting or publication of low-quality studies with unfavorable outcomes.
- The uncertainty principle mandates RCTs only when genuine uncertainty exists regarding treatment efficacy.
Purpose of the Study:
- To assess the adherence to the uncertainty principle in 136 published RCTs.
- To analyze the impact of funding source on trial quality and adherence to the uncertainty principle.
- To investigate potential bias in pharmaceutical-industry-sponsored research.
Main Methods:
- Examined 136 RCTs in multiple myeloma for adherence to the uncertainty principle.
- Compared the proportion of studies favoring experimental versus standard treatments.
- Analyzed trial quality and adherence based on funding source (for-profit vs. non-profit).
Main Results:
- Trials funded partly or wholly by for-profit organizations showed a trend towards higher quality scores (p=0.06).
- Non-profit funded studies better maintained equipoise (47% vs. 53% favoring new therapies, p=0.608).
- For-profit funded trials showed a significant bias towards experimental treatments (74% vs. 26%, p=0.004).
Conclusions:
- Violations of the uncertainty principle may explain reported bias in pharmaceutical-industry-sponsored research.
- Encouraging transparent reporting and appropriate comparative controls is crucial for clinical trial sponsors.
- Ensuring equipoise in trial design is essential for unbiased research outcomes.
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