ArticleEuropean journal of clinical pharmacology2010
Are results from pharmaceutical-company-sponsored studies available to the public?
Article in European journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Why are medical and health-related studies not being published? A systematic review of reasons given by investigators.PloS one · 2014Pooled it
- Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study.JMIR research protocols · 2016Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOnly 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.
methodsThis 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.
resultsThe 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.
conclusionsEighty 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.
Indexed as
Identifiers
20844869What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.