ReviewFrontiers in medicine2026
Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.
Review in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advanced Therapy Medicinal Products (ATMPs) can offer unprecedented therapeutic benefit for patients with limited treatment options. However, their clinical translation and early-stage clinical development remain highly complex, particularly for academic developers and small- and medium-sized enterprises (SMEs). This study presents a comprehensive analysis of the different types of challenges that ATMP developers face in initiating clinical trials, based on a scoping literature review, conducted according to the JBI methodology for scoping reviews and reported according to PRISMA-ScR. PubMed, Embase and Scopus were searched for peer-reviewed literature covering the last decade, focusing on publications discussing regulatory challenges for ATMP developers at the stage of clinical trial initiation. Our findings show that key challenges exist in four areas, comprising (a) preclinical evidence and product characteristics, (b) cell sourcing and manufacturing, (c) clinical trials and (d) regulatory landscape. Early engagement with regulators and the availability of up-to-date guidance documents emerged as key strategies to align developer efforts with regulatory expectations, while the review also identifies practical recommendations to support more efficient and harmonized clinical translation. In line with the objectives of JOIN4ATMP, these insights are valuable for developers and informative for regulators to foster more efficient and aligned ATMP development pathways.
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What Socratic holds
Registered trials
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.