German Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Gehlsheimer Str. 20, 18147, Rostock, Germany.
Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
J Transl Med. 2024 Jul 29;22(1):693. doi: 10.1186/s12967-024-05476-1.
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.
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.
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.
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.
目标产品概况(TPP)是一种在行业中使用的工具,通过解决用户需求并促进利益相关者之间的有效沟通来指导开发策略。然而,它们在学术研究中并不常用,而在学术研究中它们可能同样有用。本系统评价旨在提取可及 TPP 的特征,以识别共性并促进其纳入学术研究方法。
我们在四个生物医学数据库中,检索了以英文发表的用于开发不同产品和健康状况的 TPP 的同行评议论文。通过对随机摘要和论文集进行评估(Cohen 的 Kappa;零容忍百分比一致性),评估者间的一致性>0.91。我们采访了来自行业背景的专家,以了解 TPP 开发过程,并提取了 TPP 使用和结构的一般和具体特征。
有 138 篇论文符合数据提取标准。其中,92%(n=128)开发了新的 TPP,其中 41.3%(n=57)专注于治疗方法。所涉及的疾病类别多种多样;最大的(47.1%,n=65)是传染病。只有一个 TPP 被确定用于多个领域,包括痴呆等全球优先事项。我们的分析发现,56.5%(n=78)的论文由学者撰写,57.8%(n=80)的 TPP 具有一个产品性能的阈值水平。不同产品类型(n=3-44)的 TPP 特征数量差异很大。常见的特征包括用途/使用目的、药物稳定性的保质期和验证方面。大多数论文没有描述开发 TPP 所使用的方法。我们确定了构建和报告 TPP 时需要考虑的方面,作为指导学者使用的更有针对性的举措的起点。
TPP 在学术研究中主要用于传染病,具有异质特征。我们提取关键特征和常见结构有助于理解该工具,并扩大其在学术界的使用。这对于痴呆等明显未满足需求的领域尤其重要。利益相关者之间的合作是创新的关键。简化沟通的工具,如 TPP,可以支持学术界和工业界产品和服务的开发。