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.

Highlights

  • A Target Product Profile (TPP) outlines the necessary characteristics of an innovative product to address an unmet clinical need

  • Fourteen of the 44 TPPs focused on neglected tropical diseases (32%) and on tests for vector-borne infections (32%) (e.g. Zika virus, dengue fever, hepatitis C, malaria, E. coli)

  • We report a systematic review of the methods currently used to develop Target Product Profiles for medical tests

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Summary

Introduction

A Target Product Profile (TPP) outlines the necessary characteristics of an innovative product to address an unmet clinical need. Despite significant advances and innovation in the field of disease detection, the majority of the resulting technologies fail to be translated into tests that are used in clinical practice [1, 2]. A Target Product Profile (TPP), known as a Quality Target Product Profile (QTPP), is a strategic document which summarises the necessary characteristics of an innovative product to address an. TPPs exemplify the concept of ‘beginning with the goal in mind’, establishing key features and performance specifications in advance to ensure that the new product is developed to meet specific health-related goals [7, 8]. TPPs should be seen as ‘living’ documents that can be refined and updated as additional relevant information becomes available [7, 9]

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