| Abstrakt: |
Background: Target product profiles (TPP) were first defined by industry and supported by FDA to address user needs and guide communication in all phases of drug development. However, heterogeneity in practical use hurdles uptake in academic research. Our study aims to facilitate uptake by outlining a reference template to be adapted to dementia research. Methods: We conducted a systematic review to extract structural characteristics, along with differences and commonalities across TPPs used in different product development (e.g., drugs vs diagnostics). We included data from peer‐reviewed publications on TPPs content (i.e., developing, revising, or mentioning a TPP), product type (drug, diagnostics, vaccine, medical device, other), disease category (infectious, non‐infectious diseases), specific disease, TPP features of the target profile, and levels of compliance for each feature. Results: 327 of 1297 identified records were eligible for full‐text review. Preliminary data extraction from 20 papers shows that: Content: 45% (n = 9) developed a new TPP, 10% (n = 2) revised a predefined TPP; 45% only mentioned TPPs (n = 9). Product: of the nine papers that developed a new TPP, 77.8% (n = 7) were for drug and 22.2% (n = 2) for diagnostics development. Disease category: 70% (n = 14) used TPPs in infectious diseases while 30% (n = 6) were in non‐infectious diseases. So far, no publication reported using TPPs in dementia. TPP features for different product types from the 11 publications that developed or revised TPPs: 39 features were extracted from TPPs for diagnostic development, 11 of which (28%) were in common. We extracted 35 features from TPPs for drug development, 9 of which (27.5%) were in common. Levels of compliance ranged between one (n = 5, 45.5%) to two (n = 5, 45.5%) levels, corresponding to conservative and optimistic levels. One (9%) did not report targeted levels of compliance. Conclusion: TPPs are not frequently used by academic researchers. Despite being a useful tool enhancing product development, its considerable heterogeneity in structure renders its adaptation challenging. Completing data extraction and comparing the outcome with opinion leader's assessment and formal guidance (e.g., from WHO) will facilitate drawing a comprehensive picture of common TPP features to derive a consistent and comprehensive template and facilitate its use in academic dementia research. [ABSTRACT FROM AUTHOR] |
