ArticlePLoS medicine2009
Inadequate dissemination of phase I trials: a retrospective cohort study.
Article in PLoS medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses 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
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024Pooled it
- Risks of phase I research with healthy participants: A systematic review.Clinical trials (London, England) · 2016Pooled it
- An Evidence-Based Pathway from Functional Classification to Intraocular Lens Specialization: A Case Example Applying the PECO Framework.Ophthalmology and therapy · 2026Review
- Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials.Journal of orthopaedic surgery and research · 2023Article
- Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials.Therapeutics and clinical risk management · 2021Article
- Parkinson's Disease Drug Development Since 1999: A Story of Repurposing and Relative Success.Journal of Parkinson's disease · 2021Review
- The Limits of Conventional Justification: Inductive Risk and Industry Bias Beyond Conventionalism.Frontiers in research metrics and analytics · 2020Article
- Comparison of published and unpublished phase I clinical cancer trials: an analysis of the CliniclTrials.gov database.Investigational new drugs · 2018Review
- Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.Stem cell reports · 2017Article
- Characteristics and Dissemination of Phase 1 Trials Approved by a UK Regional Office in 2012.JAMA · 2017Article
- Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.PloS one · 2017Article
- Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey.BMC medical research methodology · 2016Article
- Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting.The oncologist · 2016Article
- Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials.PloS one · 2016Article
- Article
- Clinical trial spots for cancer patients by tumour type: The cancer trials portfolio at clinicaltrials.gov.European journal of cancer (Oxford, England : 1990) · 2015Article
- Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.BMJ open · 2015Article
- Disease specific productivity of american cancer hospitals.PloS one · 2015Observational
- Are results from pharmaceutical-company-sponsored studies available to the public?European journal of clinical pharmacology · 2010Article
- Delta inflation: a bias in the design of randomized controlled trials in critical care medicine.Critical care (London, England) · 2010Article
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 at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDrug development is ideally a logical sequence in which information from small early studies (Phase I) is subsequently used to inform and plan larger, more definitive studies (Phases II-IV). Phase I trials are unique because they generally provide the first evaluation of new drugs in humans. The conduct and dissemination of Phase I trials have not previously been empirically evaluated. Our objective was to describe the initiation, completion, and publication of Phase I trials in comparison with Phase II-IV trials. METHODS AND
findingsWe reviewed a cohort of all protocols approved by a sample of ethics committees in France from January 1, 1994 to December 31, 1994. The comparison of 140 Phase I trials with 304 Phase II-IV trials, showed that Phase I studies were more likely to be initiated (133/140 [95%] versus 269/304 [88%]), more likely to be completed (127/133 [95%] versus 218/269 [81%]), and more likely to produce confirmatory results (71/83 [86%] versus 125/175 [71%]) than Phase II-IV trials. Publication was less frequent for Phase I studies (21/127 [17%] versus 93/218 [43%]), even if only accounting for studies providing confirmatory results (18/71 [25%] versus 79/125 [63%]).
conclusionsThe initiation, completion, and publications of Phase I trials are different from those of other studies. Moreover, the results of these trials should be published in order to ensure the integrity of the overall body of scientific knowledge, and ultimately the safety of future trial participants and patients.
Indexed as
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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.