Main Category: Clinical Trials / Drug Trials
Also Included In: Pharma Industry / Biotech Industry; Arthritis / Rheumatology
Article Date: 29 May 2011 – 2:00 PDT
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Results demonstrate that 91% of RCTs recording this kind of FCOI achieved a positive – outcome, compared to 66.7% of RCTs without specific FCOI (p=0.02) and adjusting for confounding factors did not change this finding.
Results of this American study demonstrate that between the two periods 2002-3 and 2006-7 there was a significant increase in the number of RA RCTs listing lead authors as receiving consulting fees/honoraria (14.6% in the first time period compared to 40% in the second (p=0.004)). FCOIs including research grants, employment by sponsoring pharmaceutical company and share ownership were disclosed by at least one author in 53.4% of the 103 eligible RCTs studied. It could be possible that the difference noted between the two periods simply reflects a natural increase in the number of authors proactively reporting conflicts of interest.
“The number of pharmaceutical treatment options for RA has increased remarkably in recent years, partly as a result of increased funding from pharmaceutical companies,” said Dr. Khan an Assistant Professor from the Division of Rheumatology at the University of Arkansas for Medical Sciences, USA. “Our study has shown that certain FCOIs among study authors have an increased likelihood of positive outcomes favouring the sponsor‟s drug. There are many potential reasons for these results – it could be possible that more experienced clinicians hired by industry have a greater likelihood of achieving positive results because of superior trial design or that positive trials results are more likely to be published than negative ones.”
FCOIs were disclosed by at least one author in 55 of the 103 (53.4%) eligible RCTs assessed by the study authors. Forty nine (47.6%) were employed by the industry sponsor, 29 (28.2%) had received consulting fees/honoraria, 14 (13.6%) had received research grants, and 13 (12.6%) owned shares in the pharmaceutical company. However, study authors found the correlation of reporting positive outcomes was only significant in one group – for those authors receiving consulting fees/honoraria from the industry.
Study authors go on to state that “reporting of RCTs with such a high frequency of positive outcomes (72% in the overall study and approximately 90% for RCTs with authors receiving consultancy fees/honoraria or a research grant from Industry) raises ethical issues.” Dr. Khan recommends that “an RCT should only be conducted if there is substantial uncertainty about the relative value of one treatment versus another.”
The MEDLINE and Cochrane Central Register for Controlled Trials databases were searched for original, parallel-designed RA drug trials from 2002-3 and 2006-7 with clinical primary outcomes that randomly allocated patients to different treatment groups. Search terms included „Rheumatoid Arthritis‟, „Arthritis‟, „Rheumatoid‟, with a limitation to “Clinical Trials‟ and “English‟. RCT outcome was defined as positive if a statistically significant result favoring the experimental intervention for primary outcome was found.
Abstract Number: FRI0250
European League Against Rheumatism
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