ArticlePharmacoepidemiology and drug safety2017
Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.
Article in Pharmacoepidemiology and drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 177 papers, 10 of them syntheses that pooled it.
What it found
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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.
Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients
Personalized Medicine Program on Myelodysplastic Syndromes: Characterization of the Patient's Genome for Clinical Decision Making and Systematic Collection of Real World Data to Improve Quality of Health Care
Who cites it
177 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- Pegcetacoplan Delivers Real-World Therapeutic Benefits and Reduces Disease Burden for Patients With Paroxysmal Nocturnal Haemoglobinuria: A Systematic Literature Review of Pegcetacoplan Real-World Clinical and Patient-Reported Outcomes.European journal of haematology · 2026Pooled it
- A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases.Orphanet journal of rare diseases · 2024Pooled it
- Data source profile reporting by studies that use routinely collected health data to explore the effects of drug treatment.BMC medical research methodology · 2023Pooled it
- Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data.Cephalalgia : an international journal of headache · 2022Pooled it
- Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making.BMJ evidence-based medicine · 2022Pooled it
- Key Characteristics of Database Studies on Drug Effectiveness in the Postmarketing Stage: A Systematic Review.Pharmaceutical medicine · 2021Pooled it
- Second-Generation Antipsychotic Drugs for Patients with Schizophrenia: Systematic Literature Review and Meta-analysis of Metabolic and Cardiovascular Side Effects.Clinical drug investigation · 2021Pooled it
- Survival After Minimally Invasive vs Open Radical Hysterectomy for Early-Stage Cervical Cancer: A Systematic Review and Meta-analysis.JAMA oncology · 2020Pooled it
- Economic Evaluations Informed Exclusively by Real World Data: A Systematic Review.International journal of environmental research and public health · 2020Pooled it
- Effectiveness and safety of pegvisomant: a systematic review and meta-analysis of observational longitudinal studies.Endocrine · 2019Pooled it
- Novel clinical trial design and analytic methods to tackle challenges in therapeutic development in rare diseases.Annals of translational medicine · 2022Trial
- DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks).Viruses · 2022Trial
- Cost analysis of negative-pressure wound therapy versus standard treatment of acute conflict-related extremity wounds within a randomized controlled trial.World journal of emergency surgery : WJES · 2022Trial
- Molecular Testing for Thyroid Nodules of Indeterminate Cytology: A Health Technology Assessment.Ontario health technology assessment series · 2022Trial
- Cost, context, and confounding: rethinking real-world data generation and interpretation in advanced NSCLC.The oncologist · 2026Article
- Rationale and Design of ACO-REAL: A Real-World Non-Interventional Study of Acoramidis in Routine Clinical Practice.Cardiology and therapy · 2026Article
- A Comprehensive Mapping of Real-World Studies and Data Sources for Oncology in China: Insights into Landscape, Challenges, and Future Direction.Oncology and therapy · 2026Review
- Probiotic Human Study Design and Reporting (PRODARE): Recommendations to Improve Research Practice.Advances in nutrition (Bethesda, Md.) · 2026Review
- Treatment patterns in patients with castration-resistant prostate cancer who received darolutamide in the ARAMIS trial in Spain: PARASEC study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Observational
- GLP-1-based therapy and ICD-10-documented heart failure or respiratory failure events in non-diabetic adults with rheumatoid arthritis and obesity: a TriNetX federated cohort study.Clinical rheumatology · 2026Article
117 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeReal-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making.
methodsThe International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations.
resultsThe ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making.
conclusionThe focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.
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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.