ArticleJournal of evaluation in clinical practice2018
The use of mechanistic evidence in drug approval.
Article in Journal of evaluation in clinical practice, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Comment on "The Importance of Structured Expert Elicitation to Inform Outcomes Following Treatment Discontinuation: Evidence Assessment Group Perspective".PharmacoEconomics · 2026Article
- Polypharmacology in malaria treatment: single drugs, multiple mechanisms, greater impact.Trends in parasitology · 2026Review
- Protocol: a systematic review+ (SR+) to combine associative and mechanistic evidence on the efficacy of face masks in reducing transmission of respiratory diseases.Systematic reviews · 2025Article
- Rationale, design and baseline characteristics of REMODEL, a mechanism-of-action trial with semaglutide in people with type 2 diabetes and chronic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025Article
- Reforming Food, Drug, and Nutraceutical Regulations to Improve Public Health and Reduce Healthcare Costs.Foods (Basel, Switzerland) · 2025Review
- Role of TRPV1Inflammopharmacology · 2025Article
- From Efficacy to Effectiveness: Evaluating Psychedelic Randomized Controlled Trials for Trustworthy Evidence-Based Policy and Practice.Pharmacology research & perspectives · 2025Review
- Psychedelic-assisted therapy as a complex intervention: implications for clinical trial design.Therapeutic advances in psychopharmacology · 2025Review
- Mechanistic evidence and exercise interventions: Causal claims, extrapolation, and implementation.Journal of evaluation in clinical practice · 2022Article
- Pharmacogenomic testing in paediatrics: Clinical implementation strategies.British journal of clinical pharmacology · 2022Review
- Assessment of porphyrogenicity of drugs and chemicals in selected hepatic cell culture models through a fluorescence-based screening assay.Pharmacology research & perspectives · 2022Article
- The use of mechanistic reasoning in assessing coronavirus interventions.Journal of evaluation in clinical practice · 2021Article
- The use of mechanistic evidence in drug approval.Journal of evaluation in clinical practice · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
The role of mechanistic evidence tends to be under-appreciated in current evidence-based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies.
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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.