ReviewMolecular therapy. Methods & clinical development2021
Current landscape of clinical development and approval of advanced therapies.
Review in Molecular therapy. Methods & clinical development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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
33 citing papers in PubMed, 54 citations in OpenAlex.
- 3D-Printed core-shell tablet for effective oral delivery of AT-MSC secretome in inflammatory bowel disease therapy.Drug delivery and translational research · 2026Article
- Manipulating embryogenesis and testing for potential: two real problems for the regulation of stem cell-based embryo models.Journal of medical ethics · 2026Article
- The Landscape of Advanced Therapy Medicinal Products in Slovenian Transfusion Medicine: A Review of Past and Future Outlook.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026Review
- Trends in EU regulatory assessment of oncology medicines.ESMO open · 2026Article
- Hybrid SES-MEW Scaffold Strategies: A Narrative Review of Multi-Scale Fiber Architectures for Soft and Hard Tissue Engineering.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.Molecular biomedicine · 2026Review
- Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review.Molecular therapy. Advances · 2026Review
- Unconventional bioprinting modalities for advanced tissue biofabrication.Biomaterials · 2026Review
- Article
- Addressing clinical uncertainties in ATMP reimbursement: a review of methodological guidelines and European practice.Frontiers in pharmacology · 2026Review
- Landscape ofMolecular therapy. Methods & clinical development · 2025Article
- Enhancing the clinical translation of stem cell models by focusing on standardization and international regulatory cooperation.World journal of stem cells · 2025Article
- Emerging Ethical Challenges in Manufacturing of Cell-Based Medicines.Advances in experimental medicine and biology · 2025Review
- Neuropharmacological Interventions of Plant Origin for Parkinson's Disease: A Comprehensive Appraisal.Current neuropharmacology · 2025Review
- Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency.Frontiers in medicine · 2025Article
- Colorectal Cancer; Novel Approaches in Chimeric Antigen Receptors (CAR) -T cell.International journal of molecular and cellular medicine · 2025Review
- Nanoparticles: a new frontier in neurodegenerative disease therapy.Frontiers in medical technology · 2025Review
- Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency.ESMO open · 2024Article
- ATMP clinical trials in the UK.Regenerative medicine · 2024Article
- Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development.World journal of stem cells · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical development, and the complex quality aspects of those highly individualized advanced therapies are playing a key role in the clinical development, approval, and post-marketing setting for these therapies. This article reviews the current landscape of clinical development of advanced therapies, its challenges, and some of the efforts several stakeholders are conducting to move forward within this field. Progressive iteration of the science, methodologically sound clinical developments, establishing new standards for ATMPs development with the aim to ensure consistency in clinical development, and the reproducibility of knowledge is required, not only to increase the evidence generation for approval but to set principles to achieve translational success in this field.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.