Facilitating the use of the target product profile in academic research: a systematic review

Author:

Ibnidris Aliaa,Liaskos Nektarios,Eldem Ece,Gunn Angus,Streffer Johannes,Gold Michael,Rea Mike,Teipel Stefan,Gardiol Alejandra,Boccardi MarinaORCID

Abstract

Abstract Background The Target Product Profile (TPP) is a tool used in industry to guide development strategies by addressing user needs and fostering effective communication among stakeholders. However, they are not frequently used in academic research, where they may be equally useful. This systematic review aims to extract the features of accessible TPPs, to identify commonalities and facilitate their integration in academic research methodology. Methods We searched peer-reviewed papers published in English developing TPPs for different products and health conditions in four biomedical databases. Interrater agreement, computed on random abstract and paper sets (Cohen’s Kappa; percentage agreement with zero tolerance) was > 0.91. We interviewed experts from industry contexts to gain insight on the process of TPP development, and extracted general and specific features on TPP use and structure. Results 138 papers were eligible for data extraction. Of them, 92% (n = 128) developed a new TPP, with 41.3% (n = 57) focusing on therapeutics. The addressed disease categories were diverse; the largest (47.1%, n = 65) was infectious diseases. Only one TPP was identified for several fields, including global priorities like dementia. Our analyses found that 56.5% of papers (n = 78) was authored by academics, and 57.8% of TPPs (n = 80) featured one threshold level of product performance. The number of TPP features varied widely across and within product types (n = 3–44). Common features included purpose/context of use, shelf life for drug stability and validation aspects. Most papers did not describe the methods used to develop the TPP. We identified aspects to be taken into account to build and report TPPs, as a starting point for more focused initiatives guiding use by academics. Discussion TPPs are used in academic research mostly for infectious diseases and have heterogeneous features. Our extraction of key features and common structures helps to understand the tool and widen its use in academia. This is of particular relevance for areas of notable unmet needs, like dementia. Collaboration between stakeholders is key for innovation. Tools to streamline communication such as TPPs would support the development of products and services in academia as well as industry.

Funder

Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE) in der Helmholtz-Gemeinschaft

Publisher

Springer Science and Business Media LLC

Reference160 articles.

1. FDA. Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool. 2007.

2. Organization WH. Links to TPP. https://www.who.int/observatories/global-observatory-on-health-research-and-development/analyses-and-syntheses/target-product-profile/who-target-product-profiles.

3. Singh G. Target Product Profile and Clinical Development Plan. Pharmaceutical Medicine and Translational Clinical Research. Elsevier; 2018. pp. 65–80.

4. Boccardi M. Translational process. J Transl Med. 2023;21(1):677.

5. Vemuri P, Wiste HJ, Weigand SD, Shaw LM, Trojanowski JQ, Weiner MW, et al. MRI and CSF biomarkers in normal, MCI, and AD subjects: predicting future clinical change. Neurology. 2009;73(4):294–301.

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1. Why should academia care about the Target Product Profile?;Journal of Translational Medicine;2024-08-02

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