ArticleBritish journal of clinical pharmacology2007
Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization.
Article in British journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials.Deutsches Arzteblatt international · 2010Pooled it
- Efficacy gap between phase II and subsequent phase III studies in oncology.British journal of clinical pharmacology · 2020Trial
- Treatment decisions in multiple sclerosis - insights from real-world observational studies.Nature reviews. Neurology · 2017Review
- Relative efficacy and effectiveness assessment of new pharmaceuticals in three EU member states: current practices and outcome agreement between Belgium, the Netherlands and France.European journal of clinical pharmacology · 2013Article
- [Pharmaceutical prior authorization: real need or computerized antiquity?].Atencion primaria · 2013Article
- Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists.International journal of clinical pharmacy · 2012Article
- Pragmatic randomised trials using routine electronic health records: putting them to the test.BMJ (Clinical research ed.) · 2012Article
- New drugs: evidence relating to their therapeutic value after introduction to the market.Deutsches Arzteblatt international · 2012Article
- X-chromosome epigenetic reprogramming in pluripotent stem cells via noncoding genes.Seminars in cell & developmental biology · 2011Review
- Superior efficacy of new medicines?European journal of clinical pharmacology · 2010Article
- Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.Nature reviews. Drug discovery · 2010Review
- Gap in publication of comparative information on new medicines.British journal of clinical pharmacology · 2008Review
- Developments in post-marketing comparative effectiveness research.Clinical pharmacology and therapeutics · 2007Review
- Adverse drug reactions--no farewell to harms.British journal of clinical pharmacology · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo investigate the availability of information about premarketing randomized active-control trials (RaCTs) involving medicines with a new active substance at the moment of market authorization in the European Union.
methodsInformation was obtained from the EMEA European Public Assessment Reports and the MEDLINE and EMBASE databases.
resultsBetween 1999 and 2005, 48% of recently approved medicines (n = 122) had been studied in comparison with existing medicines at the moment of market authorization. About one-third of these trials were published and publicly available at that moment.
conclusionsFor most new medicines evidence-based assessment of the (added) therapeutic value is not really possible at the moment of 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.