SynthesisBMC medicine2020
Target Product Profiles for medical tests: a systematic review of current methods.
Synthesis in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Enabling digital multifactorial risk assessment in primary care: an umbrella review and recommendations for design and implementation.BMJ health & care informatics · 2026Pooled it
- Target product profiles for digital health technologies including those with artificial intelligence: a systematic review.Frontiers in health services · 2025Pooled it
- Facilitating the use of the target product profile in academic research: a systematic review.Journal of translational medicine · 2024Pooled it
- Expanding Quantitative Medicines' Reach: Systems and Methods to Enhance R&D Productivity and Decision-Making in the Agentic-Era.Clinical and translational science · 2026Article
- Specifying pathway requirements for mobile outreach cancer testing before rollout: an implementation-aware Target Product Profile method.Implementation science communications · 2026Article
- Adult blackfly (Simulium damnosum s.l.) collection methods: overview and research needs.International health · 2026Review
- Steps on the Path to Clinical Translation-A British and Irish Chapter ISMRM Workshop Survey of the UK MRI Community.Magnetic resonance in medicine · 2026Review
- Evidence gap in predicting intracranial haemorrhage risk in people with glioma on anticoagulants: a scoping review.BMC neurology · 2025Article
- Target product profile and discovery and development path for novel cryptococcal disease treatments.The Journal of infection · 2025Review
- Preferences for multi-cancer tests (MCTs) in primary care: discrete choice experiments of general practitioners and the general public in England.British journal of cancer · 2025Article
- Technologies for the point-of-care diagnosis of malaria: a scoping review.Infectious diseases of poverty · 2025Article
- Mass of components and material distribution in lateral flow assay kits.Bulletin of the World Health Organization · 2025Article
- Exploring public preferences and demand for ovarian cancer screening: a discrete choice experiment.Frontiers in oncology · 2025Article
- Disease X and COVID-19: turning lessons from India and the world into policy recommendations.Annals of medicine and surgery (2012) · 2024Review
- Why should academia care about the Target Product Profile?Journal of translational medicine · 2024Article
- Advancing Colorectal Cancer Detection With Blood-Based Tests: Qualitative Study and Discrete Choice Experiment to Elicit Population Preferences.JMIR public health and surveillance · 2024Article
- "Notification! You May Have Cancer." Could Smartphones and Wearables Help Detect Cancer Early?JMIR cancer · 2024Article
- Target Product Profile for a Machine Learning-Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study.JMIR research protocols · 2024Article
- Involving patients in drug development for Neglected Tropical Diseases (NTDs): A qualitative study exploring and incorporating preferences of patients with cutaneous leishmaniasis into Target Product Profile development.PLoS neglected tropical diseases · 2024Article
- Quality by Design Perspective for Designing Foam-based Formulation: Current State of Art.Current pharmaceutical design · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundA Target Product Profile (TPP) outlines the necessary characteristics of an innovative product to address an unmet clinical need. TPPs could be used to better guide manufacturers in the development of 'fit for purpose' tests, thus increasing the likelihood that novel tests will progress from bench to bedside. However, there is currently no guidance on how to produce a TPP specifically for medical tests.
methodsA systematic review was conducted to summarise the methods currently used to develop TPPs for medical tests, the sources used to inform these recommendations and the test characteristics for which targets are made. Database and website searches were conducted in November 2018. TPPs written in English for any medical test were included. Based on an existing framework, test characteristics were clustered into commonly recognised themes.
resultsForty-four TPPs were identified, all of which focused on diagnostic tests for infectious diseases. Three core decision-making phases for developing TPPs were identified: scoping, drafting and consensus-building. Consultations with experts and the literature mostly informed the scoping and drafting of TPPs. All TPPs provided information on unmet clinical need and desirable analytical performance, and the majority specified clinical validity characteristics. Few TPPs described specifications for clinical utility, and none included cost-effectiveness.
conclusionsWe have identified a commonly used framework that could be beneficial for anyone interested in drafting a TPP for a medical test. Currently, key outcomes such as utility and cost-effectiveness are largely overlooked within TPPs though and we foresee this as an area for further improvement.
Indexed as
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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.