ReviewPerspectives in clinical research
The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice!
Review in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- Nurse education on sedation management in ECMO: A small-group training approach.Journal of perioperative practice · 2026Article
- Development and Use of a Population Pharmacokinetic Model for Characterizing the Pharmacokinetics of Vonoprazan in Pediatric Patients.CPT: pharmacometrics & systems pharmacology · 2026Article
- Traditional Chinese medicine-based modulation of gut microbiota in coronary heart disease: probiotic synergy and translational perspectives.Frontiers in cardiovascular medicine · 2026Review
- Risk Management in First-in-Human Trials of Intravenous Drugs: Current Practices and Future Perspectives.Therapeutics and clinical risk management · 2026Review
- The effect of heat-sensitive moxibustion in the elderly with nocturia: protocol for a randomized controlled trial.Frontiers in medicine · 2025Article
- Effects of a SWELE program for improving mental wellbeing in children and adolescents with special educational needs: protocol of a quasi-experimental study.BMC pediatrics · 2024Article
- Effect of Telenursing on Supportive Care Needs in Patients with Melanoma and Lung Cancer on Targeted Therapies: A Randomised Controlled Trial Study Protocol.Methods and protocols · 2024Article
- Declaration of Helsinki 2024: Too much too late?Perspectives in clinical researchArticle
- Quality of real-world registry studies.Perspectives in clinical researchArticle
- ICH GCP E6 has arrived: Are we ready?Perspectives in clinical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The International Council for Harmonisation has released a draft version E6(R3) of the Good Clinical Practice Guideline for public consultation. The objective of the revamped guideline is to make the new provisions applicable across diverse clinical trial types and settings and to remain relevant as technological and methodological advances occur. E6(R3) includes profound changes in the structure and content of E6(R2) version, which will impact all the trial conduct processes from planning to reporting. This guideline's focus on principles, digital technology, ethics, and quality will increase the responsibilities of the ethics committees, the investigator, and the sponsor. This brief review discusses the impact of the guideline on trial conduct and the challenges of implementation in India.
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.