Observational studyBMJ open2015
Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981-2014: a retrospective observational study.
Observational study in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed, 12 citations in OpenAlex.
- A review on immunoglobulin Y (IgY) conjugated with metal nanoparticles and biomedical uses.Bioprocess and biosystems engineering · 2023Review
- Development of a rapid image-based high-content imaging screening assay to evaluate therapeutic antibodies against the monkeypox virus.Antiviral research · 2023Article
- Tackling the emerging threat of antifungal resistance to human health.Nature reviews. Microbiology · 2022Review
- SARS-CoV-2-specific immunoglobulin Y antibodies are protective in infected mice.PLoS pathogens · 2022Article
- Identification of broad anti-coronavirus chemical agents for repurposing against SARS-CoV-2 and variants of concern.Current research in virological science · 2022Article
- Immunoglobulin Y for Potential Diagnostic and Therapeutic Applications in Infectious Diseases.Frontiers in immunology · 2021Review
- Trends in the costs of drugs launched in the UK between 1981 and 2015: an analysis of the launch price of drugs in five disease areas.BMJ open · 2019Article
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 at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesRecent decades have witnessed the development of highly innovative new antiviral drug therapies. However, there are concerns that rising costs and lengthening development times could have implications for future patient access to innovative new drugs. We sought to establish whether the time taken for the clinical development of new antiviral drugs launched in the UK had increased since the 1980s. DESIGN AND
settingRetrospective observational study of all new antiviral drugs licensed for use in the UK. PRIMARY AND SECONDARY OUTCOME MEASURES: Duration of clinical development (from initiation of studies in humans to receipt of Marketing Authorisation), subdivided into clinical trial and regulatory approval periods by the date of Marketing Authorisation Application.
results48 new antiviral drugs were licensed for use in the UK between 1981 and 2014 (inclusive), over half (54%) initially for HIV infection. The overall mean duration of clinical development was 77.2 months, of which 64.6 months was spent in clinical trials before regulatory submission. The total time in clinical development increased from 41.7 months for drugs licensed 1981-1992 to 91.7 months for drugs licensed 2004-2014. This increase was accounted for by an increase in the clinical trials period and not the regulatory approval period, for which there was no observable trend. Drugs initially licensed to treat hepatitis C had a longer duration of clinical development than those indicated for other viral infections. However, the, initially shorter clinical development durations of drugs indicated for HIV infection increased more rapidly across the study period than those indicated for other viral infections.
conclusionsThe time spent by antiviral drugs in clinical development has increased markedly in recent decades despite many initiatives to speed access to innovative new drugs. However, this represents only one part of the translational research pathway, and a complete picture of development timeframes is lacking.
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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.