Are results from pharmaceutical-company-sponsored studies available to the public? 2010

Rafael Dal-Ré, and Alejandro Pedromingo, and Manuel García-Losa, and Juan Lahuerta, and Rafael Ortega
Medical Department, GlaxoSmithKline SA, Tres Cantos, Madrid, Spain. rafael.dalre@urjc.es

OBJECTIVE Only 53% and 63% of studies and clinical trials results presented at congresses are published. Company-sponsored trial results are being posted on publicly accessible Web sites. We analyzed the public availability (publication or posting on a Web site) rate, time to publication, and factors predicting public availability of results of studies sponsored by a pharmaceutical company. METHODS This was a retrospective cohort study analyzing all studies conducted by GlaxoSmithKline in Spain between 2001 and 2006. Initiation and completion were defined as first participant/first visit and last participant/last visit (or their equivalents). Papers published up to 31 March 2009 were considered. Logistic regression models were used to identify factors predicting public availability of results. RESULTS The cohort comprised 143 studies (94 clinical trials; of these, 87 were included in international products clinical development plans). Public availability rate was 80% (114/143) for all studies and 78% (73/94) for clinical trials; publication rates were 68% and 61%, respectively. The median time to publication for all studies and trials was 27.3 and 28.4 months, respectively. Study associated to a cancelled project was the only significant factor associated with lower publication rate for all studies [odds ratio (OR) 0.069; 95% confidence interval (CI) 0.02-024; p < 0.001) and trials (OR 0.075; 95% CI 0.016-0.343; p = 0.001) and a lower public availability rate (OR 0.052; 95% CI 0.007-0.382; p = 0.004) for trial results. Therapy area, sample size, positive trial results, duration of experimental phase, and being a clinical trial did not predict publication or public availability. CONCLUSIONS Eighty percent of studies included in this analysis are publicly available. Web site posting increases public availability rate of clinical trial results from 61% to 78%. Cancellation of projects is the single factor negatively influencing publication and public availability rates.

UI MeSH Term Description Entries
D012109 Research Support as Topic Work about financial support of research activities. Grants and Subsidies, Research,Subsidies, Research,Research Subsidies,Research Subsidy
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004345 Drug Industry That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function. Industries, Pharmaceutic,Industry, Drug,Industry, Pharmaceutic,Industry, Pharmaceutical,Pharmaceutical Industry,Drug Industries,Industries, Drug,Industries, Pharmaceutical,Pharmaceutic Industries,Pharmaceutic Industry,Pharmaceutical Industries
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D013030 Spain Country located between France on the northeast and Portugal on the west and bordered by the Atlantic Ocean and the Mediterranean Sea. The capital is Madrid. Balearic Islands,Canary Islands
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor
D015986 Confounding Factors, Epidemiologic Factors that can cause or prevent the outcome of interest but are not intermediate variables of the factor(s) under investigation. Confounding Factor, Epidemiologic,Confounding Factors, Epidemiological,Confounding Factors, Epidemiology,Confounding Variables,Confounding Variables, Epidemiologic,Confounding Variables, Epidemiological,Confounding Factor, Epidemiological,Confounding Factor, Epidemiology,Confounding Variable,Confounding Variable, Epidemiologic,Confounding Variable, Epidemiological,Epidemiologic Confounding Factor,Epidemiologic Confounding Factors,Epidemiologic Confounding Variable,Epidemiologic Confounding Variables,Epidemiological Confounding Factor,Epidemiological Confounding Factors,Epidemiological Confounding Variable,Epidemiological Confounding Variables,Epidemiology Confounding Factor,Epidemiology Confounding Factors,Variable, Confounding,Variable, Epidemiologic Confounding,Variable, Epidemiological Confounding,Variables, Confounding,Variables, Epidemiologic Confounding,Variables, Epidemiological Confounding
D016001 Confidence Intervals A range of values for a variable of interest, e.g., a rate, constructed so that this range has a specified probability of including the true value of the variable. Confidence Interval,Interval, Confidence,Intervals, Confidence
D016015 Logistic Models Statistical models which describe the relationship between a qualitative dependent variable (that is, one which can take only certain discrete values, such as the presence or absence of a disease) and an independent variable. A common application is in epidemiology for estimating an individual's risk (probability of a disease) as a function of a given risk factor. Logistic Regression,Logit Models,Models, Logistic,Logistic Model,Logistic Regressions,Logit Model,Model, Logistic,Model, Logit,Models, Logit,Regression, Logistic,Regressions, Logistic

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