ArticlePLoS medicine2009
The unintended consequences of clinical trials regulations.
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 42 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
42 citing papers in PubMed.
- Optimising data completeness and quality in multicentre randomised clinical trials using central data monitoring: a pragmatic approach.BMC medical research methodology · 2026Trial
- Central data monitoring in the multicentre randomised SafeBoosC-III trial - a pragmatic approach.BMC medical research methodology · 2021Trial
- Trial
- Trial
- Trial
- Trial
- Building HOPE: operationalizing hybrid decentralized oncology clinical trials with community providers beyond traditional healthcare system networks.The oncologist · 2026Article
- A python's embrace? Insurance and the global clinical trial.Health research policy and systems · 2026Article
- From Traditional Use to Molecular Mechanisms: A Bioinformatic and Pharmacological Review of the GenusBiotech (Basel (Switzerland)) · 2025Review
- The response of Canada's clinical health research ecosystem to the COVID-19 pandemic.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024Article
- Article
- Impact of the Clinical Trials Act on Noncommercial Clinical Research in Japan: An Interrupted Time-series Analysis.Journal of epidemiology · 2022Article
- Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.Clinical trials (London, England) · 2021Article
- [Ethics of resuscitation and end of life decisions].Notfall & rettungsmedizin · 2021Review
- Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?European journal of pediatrics · 2020Review
- Making consent for electronic health and social care data research fit for purpose in the 21st century.BMJ health & care informatics · 2020Article
- Article
- Challenges of international oncology trial collaboration-a call to action.British journal of cancer · 2019Review
- Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: the GenOSept experience.BMC medical ethics · 2019Article
- What are the main inefficiencies in trial conduct: a survey of UKCRC registered clinical trials units in the UK.Trials · 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
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
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.