The uncertainty principle and industry-sponsored research

Background Reporting of pharmaceutical-industry-sponsored randomised clinic al trials often result in biased findings, either due to selective reportin g of studies with non-equivalent arms or publication of low-quality papers, wherein unfavourable results are incompletely described. A randomised tria l should be conducted only if there is substantial uncertainty about the re lative value of one treatment versus another. Studies in which intervention and control are thought to be non-equivalent violates the uncertainty prin ciple. Methods We examined the quality of 136 published randomised trials that foc used on one disease category (multiple myeloma) and adherence to the uncert ainty principle. To evaluate whether the uncertainty principle was upheld, we compared the number of studies favouring experimental treatments over st andard ones. We analysed data according to the source of funding. Findings Trials funded solely or in part by 35 profit-making organisations had a trend toward higher quality scores (mean 2.94 [SD 1.3]; median 3) tha n randomised trials supported by 95 governmental or other non-profit organi sations (2.4 [0.8]; 2; p=0.06). Overall, the uncertainty principle was uphe ld, with 44% of randomised trials favouring standard treatments and 56% inn ovative treatments (p=0.17); mean and median preference evaluation scores w ere 3.7 (1.0) and 4. However, when the analysis was done according to the s ource of funding, studies funded by non-profit organisations maintained equ ipoise favouring new therapies over standard ones (47% vs 53%; p=0.608) to a greater extent than randomised trials supported solely or in part by prof it-making organisations (74% vs 26%; p=0.004). Interpretation The reported bias in research sponsored by the pharmaceutica l industry may be a consequence of violations of the uncertainty principle. Sponsors of clinical trials should be encouraged to report all results and to choose appropriate comparative controls.