Article type
Year
Abstract
Background: limited public money is available for funding research and the majority of clinical research undertaken is funded by the industry. Mechanisms to regulate conflicts of interest within the research process have been implemented. However, these policies, by themselves, do not protect against potential sponsorship bias that would affect research results to inform decision makers when using the results of these trials.
Objectives: the main aim of this study was to evaluate the influence of sponsorship bias on the treatment effects of randomized controlled trials (RCTs).
Methods: this was a meta-epidemiological study. We identified a random sample of RCTs included in meta-analyses of physical therapy (PT). Two review authors independently extracted data, including assessments of appropriate influence of funders.
We judged the influence of sponsorship to be 'appropriate' if: 1) the sponsor was acknowledged with clear statement of no involvement in the trial conduct, data management /analysis, or co-authorship; 2) sponsorship was obtained from a governmental agency or foundation; and 3) the sponsor was acknowledged only as providing equipment /devices with no involvement in designing or analyzing the trial. We judged the influence of the funder to be 'inappropriate' if the sponsor was acknowledged to be involved in the conduct of the study, and 'unclear' if there was insufficient information to permit a judgment. To determine the association between biases related to sponsorship biases and effect sizes, we conducted a two-level analysis using a meta-meta-analytic approach.
Results: we analyzed 393 trials included in 43 meta-analyses. The most common sources of sponsorship for this sample of PT trials were government (n = 205, 52.16%) followed by academic (n = 44, 11.2%), and industry (n = 39, 10%). A high percentage of the trials (n = 85, 22%) did not declare their funding. We assessed the influence of the trial sponsor as being appropriate in 246 trials (63%) and inappropriate/unclear in 147 (37%) trials. There was no a statistical significant difference in effects estimates between trials with appropriate or inappropriate influence of funders (effect size (ES) = −0.15; 95% confidence interval (CI) −0.33 to 0.03) in the sample analyzed. Although there were no statistically significant differences between trials with inappropriate or appropriate influence of funders, trials with appropriate influence of funders tended to have on average larger effect size.
Conclusion: based on our sample of PT trials, it seems that most of the trials are funded by either government and academia and a small percentage are funded by the industry. These results indicated that perhaps sponsorship bias may be not a big issue in rehabilitation-related trials
Patient or healthcare consumer involvement: we hope that the results help knowledge synthesis teams to assess and discuss sponsorship biases in the process of knowledge synthesis.
Objectives: the main aim of this study was to evaluate the influence of sponsorship bias on the treatment effects of randomized controlled trials (RCTs).
Methods: this was a meta-epidemiological study. We identified a random sample of RCTs included in meta-analyses of physical therapy (PT). Two review authors independently extracted data, including assessments of appropriate influence of funders.
We judged the influence of sponsorship to be 'appropriate' if: 1) the sponsor was acknowledged with clear statement of no involvement in the trial conduct, data management /analysis, or co-authorship; 2) sponsorship was obtained from a governmental agency or foundation; and 3) the sponsor was acknowledged only as providing equipment /devices with no involvement in designing or analyzing the trial. We judged the influence of the funder to be 'inappropriate' if the sponsor was acknowledged to be involved in the conduct of the study, and 'unclear' if there was insufficient information to permit a judgment. To determine the association between biases related to sponsorship biases and effect sizes, we conducted a two-level analysis using a meta-meta-analytic approach.
Results: we analyzed 393 trials included in 43 meta-analyses. The most common sources of sponsorship for this sample of PT trials were government (n = 205, 52.16%) followed by academic (n = 44, 11.2%), and industry (n = 39, 10%). A high percentage of the trials (n = 85, 22%) did not declare their funding. We assessed the influence of the trial sponsor as being appropriate in 246 trials (63%) and inappropriate/unclear in 147 (37%) trials. There was no a statistical significant difference in effects estimates between trials with appropriate or inappropriate influence of funders (effect size (ES) = −0.15; 95% confidence interval (CI) −0.33 to 0.03) in the sample analyzed. Although there were no statistically significant differences between trials with inappropriate or appropriate influence of funders, trials with appropriate influence of funders tended to have on average larger effect size.
Conclusion: based on our sample of PT trials, it seems that most of the trials are funded by either government and academia and a small percentage are funded by the industry. These results indicated that perhaps sponsorship bias may be not a big issue in rehabilitation-related trials
Patient or healthcare consumer involvement: we hope that the results help knowledge synthesis teams to assess and discuss sponsorship biases in the process of knowledge synthesis.