ArticleTransactions of the American Clinical and Climatological Association2018
EFFICACY-TO-EFFECTIVENESS CLINICAL TRIALS.
Article in Transactions of the American Clinical and Climatological Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed, 9 citations in OpenAlex.
- Fecal microbiota transplant and its usefulness in hepatic disorders: a systematic review.Therapeutic advances in gastroenterology · 2026Review
- Effectiveness and safety of vericiguat in patients with heart failure and reduced ejection fraction: a narrative review of real-world evidence studies.Frontiers in cardiovascular medicine · 2025Review
- Review
- Review
- Development, implementation, and dissemination of operational innovations across the trial innovation network.Journal of clinical and translational science · 2023Article
- The Complex Maze of the Informed Consent Process: Helping to Improve Comprehension in Clinical Trial Participants with Alzheimer's Disease.Journal of Alzheimer's disease reports · 2020Article
- Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes.Journal of diabetes science and technology · 2019Article
- Efficacy and Effectiveness Too Trials: Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice.Clinical pharmacology and therapeutics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Efficacy trials, which assess treatments in optimally selected patients under advantageous conditions for relatively short time periods, are necessary to gain regulatory approval for marketing. In contrast, effectiveness trials, which test treatments across a spectrum of patients in real-world conditions with follow-up periods that match typical treatment regimens, provide critical information on drug effects in those patients who may ultimately receive the treatment. We previously proposed a study design that integrates efficacy and effectiveness trials into a 2-component "efficacy-to-effectiveness (E2E) trial," in which if the initial efficacy trial component is positive, then the trial immediately and seamlessly transitions to the effectiveness trial component. However, we believe that total study duration could be even further shortened by simultaneously addressing efficacy and effectiveness too (EE2). An EE2 trial rigorously demonstrates efficacy, but uses broad inclusion characteristics of effectiveness trials. An example of a study using EE2 design, the IMMEDIATE (Immediate Myocardial Metabolic enhancement During Initial Assessment and Treatment in Emergency Care) trial, is provided.
Indexed as
Identifiers
30166723PMC6116609W2982760917What 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.