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@ARTICLE{AhmedIbnidrisElsiddig:271064,
      author       = {Ahmed Ibnidris Elsiddig, Aliaa and Liaskos, Nektarios and
                      Eldem, Ece and Gunn, Angus and Streffer, Johannes and Gold,
                      Michael and Rea, Mike and Teipel, Stefan and Gardiol,
                      Alejandra and Boccardi, Marina},
      title        = {{F}acilitating the use of the target product profile in
                      academic research: a systematic review.},
      journal      = {Journal of translational medicine},
      volume       = {22},
      number       = {1},
      issn         = {1479-5876},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DZNE-2024-00936},
      pages        = {693},
      year         = {2024},
      abstract     = {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.},
      subtyp        = {Review Article},
      keywords     = {Academia / Humans / Biomedical Research / Methodology
                      (Other) / Quality by design (Other) / TPP (Other) / Target
                      product profile (Other) / Translational methods (Other) /
                      Translational research (Other)},
      cin          = {AG Boccardi / AG Teipel},
      ddc          = {610},
      cid          = {I:(DE-2719)5000062 / I:(DE-2719)1510100},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39075460},
      pmc          = {pmc:PMC11288132},
      doi          = {10.1186/s12967-024-05476-1},
      url          = {https://pub.dzne.de/record/271064},
}