Data Sheet 1_Why advanced therapy medicinal products struggle in clinical translation: an

Charlotte Van Isterdael's study analyzes challenges in the clinical translation of Advanced Therapy Medicinal Products (ATMPs) for academic and SME developers in the EU. The analysis is based on a scoping literature review of peer-reviewed publications from PubMed, Embase, and Scopus covering the last decade. The findings, published on figshare in 2026, identify key challenges in preclinical evidence, manufacturing, clinical trials, and the regulatory landscape.

Use Cases

• Identify common regulatory hurdles for ATMP developers based on the scoping review of literature.
• Analyze strategies for early regulator engagement based on the study's identified key recommendations.
• Map challenges in cell sourcing and manufacturing processes for ATMPs based on the four-area framework presented.
• Support policy analysis for harmonizing ATMP development pathways based on the review's practical recommendations.

Strengths

• Analysis is based on a scoping literature review conducted according to JBI methodology and reported per PRISMA-ScR guidelines.
• The review searched three major biomedical databases (PubMed, Embase, Scopus) for peer-reviewed literature.
• The dataset is openly licensed under CC-BY-4.0.

Limitations

• The dataset is a 236.1 KB PDF document, which is a very small text file containing analysis, not a primary data collection.
• Row count and column-level documentation are absent; the content is a narrative analysis.
• The description does not specify the exact number of publications reviewed or provide the underlying extracted data.

Provenance

Source

Charlotte Van Isterdael, via figshare.

Collection Method

Scoping literature review of peer-reviewed publications from PubMed, Embase, and Scopus.

Time Range

Publications from the last decade prior to the study's creation.

Freshness

Last updated 2026-06-02 12:26:33.

Geography

Focus on the European Union regulatory landscape.