ArticlePharmacoepidemiology and drug safety2023
HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
Article in Pharmacoepidemiology and drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 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
60 citing papers in PubMed.
- Safety monitoring of bivalent, quadrivalent, and 9-valent human papillomavirus vaccination in Japan: The vaccine effectiveness, networking, and universal safety (VENUS) study.Human vaccines & immunotherapeutics · 2026Article
- Toward the Use of Real-World Data for Regulatory and HTA Decision-Making: Experiences and Recommendations from Six EU-Funded Projects.Clinical pharmacology and therapeutics · 2026Review
- Reproducibility in biomedical research.Nature medicine · 2026Review
- Employing General-Purpose and Biomedical Large Language Models with Advanced Prompt Engineering for Pharmacoepidemiologic Study Design.Pharmaceutical research · 2026Article
- Clinical and cost-effectiveness of an acute medical unit model in Singapore: protocol for a pilot prospective cohort study.BMJ open · 2026Article
- Leveraging generative artificial intelligence for the development of non-interventional research study protocols: a proof-of-concept feasibility study.BMC medical research methodology · 2026Article
- Transportability Analyses in Comparative Effectiveness Research: A Conceptual Framework and Methodological Principles Endorsed by the International Society for Pharmacoepidemiology.Pharmacoepidemiology and drug safety · 2026Article
- Protocol for the development and validation of a risk score to predict risk of adverse events associated with systemic anti-cancer treatment in late-stage lung cancer: Lung Cancer Improved Decisions (LUCID).Diagnostic and prognostic research · 2026Review
- Privacy rights and improving knowledge are not hierarchical needs: data protection and good epidemiologic standard (DP_GOES) checklist for retrospective observational studies using secondary data.BMC medical research methodology · 2026Article
- Advancing real-world evidence in Brazil: regulatory gaps and global lessons.Lancet regional health. Americas · 2026Review
- Enhancing evidence-based care using trial emulation in electronic health records: real-world effects of empagliflozin in people with type 2 diabetes.BMJ open diabetes research & care · 2026Article
- Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.Clinical and translational science · 2026Review
- Review
- Trust and trade: patient perspectives on the ethics of real-world data monetisation.Frontiers in health services · 2026Article
- RESCUE-CD - Real-world effectiveness of risankizumab in moderate-to-severe Crohn's disease: a case series involving the most refractory and challenging patients.Przeglad gastroenterologiczny · 2026Article
- Epigenetic plasticity and chemoresistance in cancer: mechanisms, biomarkers, and translational opportunities for real-world evidence.Frontiers in cell and developmental biology · 2026Review
- Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice.Nature medicine · 2026Article
- Supporting complex mental health care and services research today and beyond: a mini-review of real-world evidence strategies and informed approaches.Frontiers in health services · 2026Review
- Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend.Clinical pharmacology and therapeutics · 2025Review
- Preregistration of high-quality protocols in pharmacoepidemiology research.JCPP advances · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
Abstract
problemAmbiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias. WHAT WE DID: The International Society for Pharmacoepidemiology (ISPE) and ISPOR-The Professional Society for Health Economics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The overarching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. STRATEGIES TO DISSEMINATE AND FACILITATE USE: Recognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years.
conclusionThe HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.
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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.