Evidence map›Paper›PMID 39075460›Full record

SynthesisJournal of translational medicine2024

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

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

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of translational medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Why should academia care about the Target Product Profile?Journal of translational medicine · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Aliaa IbnidrisGerman Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Gehlsheimer Str. 20, 18147, Rostock, Germany.
Nektarios LiaskosGerman Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Gehlsheimer Str. 20, 18147, Rostock, Germany.
Ece EldemGerman Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Gehlsheimer Str. 20, 18147, Rostock, Germany.
Angus GunnUCB, Brussels, Belgium.
Johannes StrefferReference Center for Biological Markers of Dementia (BIODEM), Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium.
Michael GoldAriLex Life Sciences LLC, 780 Elysian Way, Deerfield, IL, 60015, USA.
Mike ReaIDEA Pharma, London, UK.
Stefan TeipelGerman Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Gehlsheimer Str. 20, 18147, Rostock, Germany.
Alejandra GardiolEuropean Infrastructure for Translational Medicine (EATRIS), Amsterdam, The Netherlands.
Marina BoccardiGerman Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Gehlsheimer Str. 20, 18147, Rostock, Germany. marina.boccardi@dzne.de.ORCID 0000-0001-6744-8246

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsWe 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.

results138 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.

Indexed as

Biomedical ResearchAcademiaMethodologyQuality by designTarget product profileTPPTranslational methodsTranslational research

Identifiers

PMID39075460
PMCPMC11288132

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.