ReviewCirculation2016
Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.
Review in Circulation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07145060 (A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome), which is not on this map. Cited by 67 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.
A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome
Who cites it
67 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The relationship between pragmatism, timing, and study size on impact of randomized trials: a qualitative, hypothesis generating study of trials of systemic corticosteroids for COVID-19.Journal of clinical epidemiology · 2022Pooled it
- A study within a trial evaluating supplemental, reinforced risk-based training to reduce implementation barriers in a pediatric multicenter randomized controlled trial.Contemporary clinical trials · 2026Trial
- Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study.Journal of translational medicine · 2022Trial
- The effect of intermittent pneumatic compression on deep-vein thrombosis and ventilation-free days in critically ill patients with heart failure.Scientific reports · 2022Trial
- Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study.Drug design, development and therapy · 2022Trial
- Integrative evaluation of primary and metastatic lesion spectrum to guide anti-PD-L1 therapy of non-small cell lung cancer: results from two randomized studies.Oncoimmunology · 2021Trial
- Efficacy of a Stannous-containing Dentifrice for Protecting Against Combined Erosive and Abrasive Tooth Wear In Situ.Oral health & preventive dentistry · 2020Trial
- Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).American heart journal · 2017Trial
- Remimazolam for preventing sevoflurane-induced emergence delirium after pediatric laparoscopic inguinal hernia repair: a placebo-controlled randomized clinical trial.Jornal de pediatriaTrial
- C-reactive protein-to-lymphocyte ratio and perforation in pediatric appendicitis.Surgery today · 2026Article
- A methodological review of pragmatic designs in acute stroke trials.International journal of stroke : official journal of the International Stroke Society · 2026Review
- Applying the Evidence Pyramid to Breastfeeding and Lactation Research.Journal of human lactation : official journal of International Lactation Consultant Association · 2026Article
- Diabetes management using a clinical guideline versus usual practice: a feasibility trial-based qualitative study among Ayurvedic practitioners and patients in Nepal.Therapeutic advances in endocrinology and metabolism · 2026Article
- Pharmacoepidemiology unpacked: a roadmap for junior researchers.Frontiers in pharmacology · 2026Review
- Delivering optimal weight gain advice to pregnant women by lead maternity carer midwives in a real-world setting to optimise health outcomes (DOT study): a case study protocol.BMC public health · 2025Article
- A scoping review of artificial intelligence applications in clinical trial risk assessment.NPJ digital medicine · 2025Article
- The Case for Aggregated Rehabilitation-Relevant Data Across Health Care Systems and Settings.Physical therapy · 2025Article
- Effect of Transcranial Direct Current Stimulation on Memory and Emotional Recovery in Patients with Stroke and Traumatic Brain Injury: A Prospective, Multicenter, Interventional Pilot Study.Journal of clinical medicine · 2025Article
- Effectiveness of electronic medical record-based strategies for death and hospital admission endpoint capture in pragmatic clinical trials.Journal of the American Medical Informatics Association : JAMIA · 2025Article
- Article
7 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age.
Indexed as
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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.