Article type
Year
Abstract
Background: Industry support for treatment-related research has been considerable and poses a threat to scientific integrity, yet trial sponsorship is not one of the Institute of Medicine criteria.
Objectives: To use the American College of Occupational and Environmental Medicine Opioid practice guidelines to assess whether there is a relationship between the degree of industry sponsorship and the trial outcome.
Methods: High- and moderate-quality randomized controlled trials were identified. Trials were included if the opioid drug was compared to a placebo-control group. Sponsorship was identified as: non-industry, industry-supported, and industry-sponsored trial. Outcomes were defined as either positive or negative. A positive outcome was defined as a result for the primary endpoint that was statistically significant compared to the control group. Fisher’s Exact Test analyses were used to determine the relationship between the type of sponsorship and the trial outcome.
Results: Seventy-seven trials were identified. The majority were industry-supported (N = 35; 45.5%), while 24 (31.2%) were industry-sponsored, and 18 (23.4%) were non-industry trials. The majority of industry-supported trials showed a positive outcome (N = 32; 91.4%). Similar results were found for industry-sponsored trials (N = 21; 87.5%). No significant relationship was found between the type of sponsorship and the trial outcome (P value 0.38).
Conclusions: A majority of evidence regarding efficacy of opioids is industry-supported or sponsored (76.6%). Sponsored studies have been reported to have better results and lower complication rates than studies conducted by independent investigators. This analysis failed to confirm these results regarding industry conflict among studies of opioids. However, type of sponsorship should be included by the Institute of Occupational Medicine as a standard for developing practice guidelines due to prior reports of potential differential impacts on outcomes.
Objectives: To use the American College of Occupational and Environmental Medicine Opioid practice guidelines to assess whether there is a relationship between the degree of industry sponsorship and the trial outcome.
Methods: High- and moderate-quality randomized controlled trials were identified. Trials were included if the opioid drug was compared to a placebo-control group. Sponsorship was identified as: non-industry, industry-supported, and industry-sponsored trial. Outcomes were defined as either positive or negative. A positive outcome was defined as a result for the primary endpoint that was statistically significant compared to the control group. Fisher’s Exact Test analyses were used to determine the relationship between the type of sponsorship and the trial outcome.
Results: Seventy-seven trials were identified. The majority were industry-supported (N = 35; 45.5%), while 24 (31.2%) were industry-sponsored, and 18 (23.4%) were non-industry trials. The majority of industry-supported trials showed a positive outcome (N = 32; 91.4%). Similar results were found for industry-sponsored trials (N = 21; 87.5%). No significant relationship was found between the type of sponsorship and the trial outcome (P value 0.38).
Conclusions: A majority of evidence regarding efficacy of opioids is industry-supported or sponsored (76.6%). Sponsored studies have been reported to have better results and lower complication rates than studies conducted by independent investigators. This analysis failed to confirm these results regarding industry conflict among studies of opioids. However, type of sponsorship should be included by the Institute of Occupational Medicine as a standard for developing practice guidelines due to prior reports of potential differential impacts on outcomes.