SynthesisBritish journal of clinical pharmacology2025
Medication adherence during the run-in phase of clinical trials: A systematic review of methodological and reporting rigour.
Synthesis in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Medication adherence during the run-in phase of clinical trials: A systematic review of methodological and reporting rigour.British journal of clinical pharmacology · 2025Pooled it
- Article
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
Abstract
aimsTrial run-in phases are sometimes used to select adherent participants as a strategy to enrich trials, but the methods employed lack clear regulatory guidance and there are concerns about the transparency of reporting. This review aims to characterize the methods used for adherence measurement and public reporting of run-in studies.
methodsThe protocol is published on the Open Science Framework. CLINICALTRIALS: gov was searched using the terms "run*in", "lead*in", "enrichment" or "single-blind placebo". The Risk of Bias tool for Observational Adherence Studies (RoBOAS) and the ESPACOMP Medication Adherence Reporting Guideline (EMERGE) were used to assess methodological and reporting quality. A narrative synthesis of the evidence was undertaken.
resultsIn total, 249 studies were identified, 34 were included for the analysis, of which 8 specified adherence to be a main purpose of the run-in. Most (20/34) used pill counts and of those using an explicit threshold for adherence, 13/31 used an 80% cut-off. The reporting of the adherence measurement method, summary metric and method of data aggregation was complete in 23/34 run-ins, but none publicly reported the adherence phase considered or presented any adherence data. All run-ins were judged to be of poor methodological quality, and at critical risk of bias.
conclusionsThe methodological and public reporting quality of medication adherence in run-in phases of drug trials may compromise their intended purpose of improving the quality of the main trial. These findings have regulatory implications and support the need for guidelines on the measurement, analysis and reporting of adherence during the run-in phase.
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.