ReviewClinical pharmacology and therapeutics2021
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.
Review in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05587777 (REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data), which is not on this map. Cited by 116 papers, 4 of them syntheses 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.
REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
Who cites it
116 citing papers in PubMed, 4 syntheses or guidelines pooled it, 186 citations in OpenAlex.
- Availability of secondary healthcare data for conducting pharmacoepidemiology studies in Mexico: a systematic review.Journal of comparative effectiveness research · 2026Pooled it
- Real-World Effectiveness of Triple Extrafine Fixed-Dose Combination with Beclomethasone/Formoterol/Glycopyrronium on Symptoms and Lung Function in COPD: A Systematic Review and Meta-Analysis.International journal of chronic obstructive pulmonary disease · 2025Pooled it
- Evaluation of reporting quality of cohort studies using real-world data based on RECORD: systematic review.BMC medical research methodology · 2023Pooled it
- The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.Clinical pharmacology and therapeutics · 2022Pooled it
- Comparability of external and internal control patients for the prospective randomized HOVON-103 trial in older AML patients.British journal of haematology · 2026Trial
- Effectiveness and safety of everolimus treatment in patients with tuberous sclerosis complex in real-world clinical practice.Orphanet journal of rare diseases · 2023Trial
- Methodological innovations to advance substance use disorder research: Proceedings of a NIDA workshop on target trial emulation and translational testing of digital health tools.Journal of substance use and addiction treatment · 2026Article
- Internet-Delivered Cognitive Behavioral Therapy for Social Anxiety Disorder: Nationwide Retrospective Cohort Observational Study.Journal of medical Internet research · 2026Observational
- Evaluating the Complementary Nature of Randomized Controlled Trials and Real-World Evidence Using Over 5 Years of Experience with Fremanezumab: A Narrative Review.Advances in therapy · 2026Review
- Do the math: modernizing the FDA's evidence paradigm for precision medicine.The Journal of clinical investigation · 2026Article
- Bleeding Risk With Apixaban Versus Rivaroxaban: A Reference Trial Emulation Predicting the Results of COBRRA-VTE and COBRRA-AF Using US Health Care Claims.Circulation. Population health and outcomes · 2026Observational
- Quality of Life and Psychological Factors in Patients with Metastatic Prostate Cancer Receiving Androgen Receptor-Targeted Therapies: A Prospective Cross-Sectional Real-World Study.Medicina (Kaunas, Lithuania) · 2026Observational
- Federated autoencoder-based clinical decision framework with hybrid class balancing.Scientific reports · 2026Article
- Trends in EU regulatory assessment of oncology medicines.ESMO open · 2026Article
- Prevention of Severe Postoperative Pain after Breast Surgery Using Opioid-Sparing Analgesia with Intraoperative and Drain-Based Ropivacaine Infiltration: A Prospective Observational Study.Breast care (Basel, Switzerland) · 2026Article
- Emulating Six Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real-World Databases from Korea and Taiwan.Clinical pharmacology and therapeutics · 2026Article
- Clinically Meaningful, Patient-Centered Endpoints for Real-World Evidence Generation in Breast Cancer: Perspectives from the Multidisciplinary TRIUMPH Initiative.Advances in therapy · 2026Article
- A Multicentre, Prospective, Non-Interventional Single-Arm Study Investigating the Impact of Once-Daily Oral Semaglutide in a Real-World Adult Population With Type 2 Diabetes in Mexico.Endocrinology, diabetes & metabolism · 2026Article
- Article
- Observational
56 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Compared with drugs from the blockbuster era, recently authorized drugs and those expected in the future present a heterogenous mix of chemicals, biologicals, and cell and gene therapies, a sizable fraction being for rare diseases, and even individualized treatments or individualized combinations. The shift in the nature of products entails secular trends for the definitions of "drugs" and "target population" and for clinical use and evidence generation. We discuss that the lessons learned from evidence generation for 20th century medicines may have limited relevance for 21st century medicines. We explain why the future is not about randomized controlled trials (RCTs) vs. real-world evidence (RWE) but RCTs and RWE-not just for the assessment of safety but also of effectiveness. Finally, we highlight that, in the era of precision medicine, we may not be able to reliably describe some small treatment effects-either by way of RCTs or RWE.
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.