ReviewBritish journal of clinical pharmacology2008
Gap in publication of comparative information on new medicines.
Review in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Comparison of Drug Utilization Patterns in Observational Data: Antiepileptic Drugs in Pediatric Patients.Paediatric drugs · 2015Article
- The answer is 17 years, what is the question: understanding time lags in translational research.Journal of the Royal Society of Medicine · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
what is already known about this subjectRandomized active control trials are used by health care professionals and reimbursement authorities for the assessment of the added value of a new medicine. Failing to publish the results of clinical trials limits making an evidence based assessment and conducting systematic reviews. WHAT THIS STUDY ADDS: About one-third of the comparative trials used in the authorization process are published at the moment of market authorization and about four out of five within 2 or 3 years. Most of the rest remain unpublished. Unpublished trials contain information regarding a different therapeutic use or a different comparator of the same medicine and, in some cases, have influenced the risk : benefit assessment of the registration authorities. A standardized public registration of results of the main premarketing trials is advocated to fill the publication gap.
aimsTo determine the time-lag between the EU authorization of new medicines and the publications of the main randomized active control trials (RaCTs) used in the authorization process and to compare unpublished with published RaCTs of the same medicine.
methodsAll RaCTs for new medicines with a new active substance, authorized between 1999 and 2003, were extracted from the European Public Assessment Reports (EPAR). Information about the publication status of RaCTs was obtained from the MEDLINE and EMBASE databases.
resultsWe identified 116 RaCTs for 42 new medicines; 28% of the RaCTs had been published at the moment of market authorization, 59% after 1 year, 78% after 2 and 83% after 3 years. Most of the rest of the studies remained unpublished after 3 years of follow-up. Unpublished RaCTs differed from published trials of the same medicine especially regarding therapeutic use and/or comparator. In some cases unpublished trials have influenced the risk : benefit asssessment of the registration authorities.
conclusionsMost of the main RaCTs, relevant for assessing the added value of a new medicine, are published subsequent to market entry; some of these trials remain unpublished. We argue for a standardized public registration of the results of the main premarketing clinical trials as a condition for market authorization.
Indexed as
Identifiers
What 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.