ReviewNature reviews. Drug discovery2010
Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.
Review in Nature reviews. Drug discovery, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 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
43 citing papers in PubMed.
- Phase IV non-inferiority trials and additional claims of benefit.BMC medical research methodology · 2013Trial
- Can regulators have a role in facilitating the development of new medicines for Parkinson's disease?Journal of Parkinson's disease · 2026Review
- Assessment and Appraisal of Drug Innovativeness in Italy: Ultimate Evidence on Key Drivers and Consistency.Journal of market access & health policy · 2026Article
- Article
- Capturing Unanticipated Drug Toxicities Using an Ensemble Machine Learning Approach.Research square · 2025Article
- Advice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Mesenchymal stem cell secretome and extracellular vesicles for neurodegenerative diseases: Risk-benefit profile and next steps for the market access.Bioactive materials · 2023Review
- Chronological Analysis of First-in-Class Drugs Approved from 2011 to 2022: Their Technological Trend and Origin.Pharmaceutics · 2023Article
- Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project.British journal of clinical pharmacology · 2022Review
- The value of anticancer drugs - a regulatory view.Nature reviews. Clinical oncology · 2022Review
- Comparing direct acting antivirals for hepatitis C using observational data - Why and how?Pharmacology research & perspectives · 2020Observational
- Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges.Frontiers in medicine · 2020Review
- Leaping Together Toward Sustainable, Patient-Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change.Clinical pharmacology and therapeutics · 2019Article
- A simple model to solve a complex drug toxicity problem.Toxicology research · 2019Article
- The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach.Frontiers in medicine · 2019Review
- Design of non-inferiority randomized trials using the difference in restricted mean survival times.Clinical trials (London, England) · 2018Article
- A proposal for a new PhD level curriculum on quantitative methods for drug development.Pharmaceutical statistics · 2018Article
- Time matters in multiple sclerosis: can early treatment and long-term follow-up ensure everyone benefits from the latest advances in multiple sclerosis?Journal of neurology, neurosurgery, and psychiatry · 2018Article
- A systematic literature review on the efficacy-effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs.Clinical epidemiology · 2017Review
- How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.British journal of clinical pharmacology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.
Indexed as
Identifiers
20186141What 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.