ReviewJournal of epidemiology and global health2015
Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).
Review in Journal of epidemiology and global health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Promoting awareness of terminology related to unmet medical needs in context of rheumatic diseases in Japan: a systematic review for evaluating unmet medical needs.Rheumatology international · 2023Pooled it
- External validity and responsiveness of lumbar spinal stenosis-specific symptom and QOL scales: A multicenter prospective study.Scientific reports · 2026Article
- From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018-2022).Frontiers in pharmacology · 2025Article
- National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Article
- Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?Patient related outcome measures · 2022Review
- Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions.Transplant international : official journal of the European Society for Organ Transplantation · 2022Article
- Article
- Results on patient-reported outcomes are underreported in summaries of product characteristics for new drugs.Journal of patient-reported outcomes · 2021Article
- Progress in Vaccination of Prophylactic Human Papillomavirus Vaccine.Frontiers in immunology · 2020Review
- The past, present and future of opioid withdrawal assessment: a scoping review of scales and technologies.BMC medical informatics and decision making · 2019Article
- Achieving comprehensive remission or low disease activity in rheumatoid patients and its impact on workability - Saudi Rheumatoid Arthritis Registry.Open access rheumatology : research and reviews · 2019Article
- Patient-reported outcome claims in European and United States orphan drug approvals.Journal of market access & health policy · 2018Article
- The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2017Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency.
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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.