Analyzes developmental challenges in clinical trials for advanced therapy medicinal products, indicating practical recommendations for developers and regulators.
Key Points
The aim is to dissect the obstacles faced by Advanced Therapy Medicinal Products developers during clinical trial initiation.
Conducted a scoping literature review following JBI methodology and PRISMA-ScR reporting guidelines.
Reviewed articles from PubMed, Embase, and Scopus over the last decade regarding regulatory challenges.
Identified challenges in preclinical evidence, manufacturing, clinical trials, and regulatory landscape.
Identified four primary challenge areas for ATMP developers: preclinical evidence, cell sourcing, clinical trials, and regulatory landscape.
Highlighted early engagement with regulators and updated guidance as key strategies for successful development.
Provided practical recommendations to enhance alignment with regulatory expectations.