Year: 2018
Type: article
Abstract: Potential bias in clinical trials related to relationships with the pharmaceutical industry is a longstanding concern. 1 Between 2005 and 2013, JAMA journals required industry-sponsored studies to conduct independent statistical analysis (ISA), defined as data analysis by an “independent statistician at an academic institution” using the raw data set. 2 While no journals currently require ISA, the term may be used to denote impartiality and robustness in data analysis. 2 3 However, its meaning, frequency of use, and association with study characteristics are not clear. Our study’s purpose was to investigate the prevalence and characteristics of ISA in published RCTs focused on drug efficacy and their adherence to JAMA’s definition. We searched MEDLINE and randomly selected 646 drug efficacy RCTs from 2013, as described previously; 4 190 met inclusion criteria. Two of four reviewers (AA, RA, AW, SS) independently abstracted data regarding trial characteristics, clinical area, results, funding source, investigator/manufacturer financial ties, and description of ISA or independent statistician. Among papers reporting ISA, we abstracted in duplicate information concerning the analysis the sponsor’s relationship to data and analyses, and statistician(s) identity. Disagreements were resolved by consensus. When ISA was described, we determined conformity with its definitional components (academic statistician affiliation and use of the full dataset) and the relationship between ISA and study characteristics and outcome. We used the Mann–Whitney test for continuous variables and Chi-squared for categorical variables (SAS, V9). Among the 190 trials, 17 (8.9%) reported ISA; the majority (15, 88%) were industry-funded and published in high impact journals (IF > 10) (12, 71%) (Table 1 ). Most identified the independent statistician(s) by name (11, 65%). Roles of independent statisticians varied; they led the analysis in eight trials (47%), validated the sponsors analysis in four (24%), provided statistical assistance in three (18%), and had an unspecified role in two (12%). ISA adhered to both components of the definition in seven trials (41%); independent analysts had academic affiliation in 13 trials (76%) and full dataset access in 11 (65%). ISA was not associated with industry funding ( p value = 0.07), positive study outcome ( p value = 0.31), or financial ties to the manufacturer ( p value = 0.42). ISA was strongly associated with sample size ( p value < 0.0001) and clinical area ( p value < 0.001), notably cardiology. ISA was not associated with trial registration, analysis type, phase, comparator, outcome measure, or first author country (Table 1 ).
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $5,290
OpenAlex ID: W2790186043