A literature review was conducted with the expressions “Clinical Trial” and “Clinical Trial and ATMPs”, in English and in French between the 4 November and 02 December 2025, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Brill revues, Cairn revues, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.
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Almonacid C, Cosío BG, Muñoz Gall X, et al. Optimising clinical trial management in Spain: The CARABELA-Clinical trials framework integrating healthcare models and subject experiences. Contemporary Clinical Trials Communications. 2025;48:101544.
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Atzor S, Gokhale S, Doherty M. Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients? Pharm Med. 2013;27(2):75-82.
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Aulois-Griot M. Les oubliés de la santé : à propos des médicaments orphelins et des médicaments pédiatriques. RDSS | Dalloz. 2007;(4):613-622.
Bauzon J, Bath F, Escobedo B, Zhou MY, Siperstein A, Romero-Velez G. Variability of prospective general surgery trials by subspecialty: An analysis of the national clinical trials registry. Surgery. Published online November 29, 2025:109901.
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Beattie S, Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio). Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union. Hum Gene Ther. 2021;32(19-20):997-1003. doi:10.1089/hum.2021.058
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Benabdellah K, Sánchez-Hernández S, Aguilar-González A, et al. Genome-edited adult stem cells: Next-generation advanced therapy medicinal products. STEM CELLS Translational Medicine. 2020;9(6):674-685. doi:10.1002/sctm.19-0338
Benkimoun P. Recherche clinique et financement privé : les liaisons dangereuses. Les Tribunes de la santé. 2010;28(3):23-37. doi:10.3917/seve.028.0023
Blay JY, Delord JP. Impact de la mise en œuvre du règlement européen sur les dispositifs médicaux de diagnostic in vitro dans les essais cliniques : une histoire européenne. Innovations & Thérapeutiques en Oncologie. 2024;10(5):281-283. doi:10.1684/ito.2024.465
Bocquet F, Paubel P. Les aspects juridiques du développement des médicaments biosimilaires. RDSS | Dalloz. 2012;(1):121-133.
Bodden D, Schoenen S, Wied S, et al. Multi-stakeholder sessions on major innovation topics in rare disease clinical trials. Orphanet J Rare Dis. 2024;19(1):467.
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Bond A, Robertson T, Fletcher C, Theogaraj E, Jordinson G, Askin S. Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials. Ther Innov Regul Sci. 2025;59(6):1211-1218. doi:10.1007/s43441-025-00796-w
Boráň T, Menezes-Ferreira M, Reischl I, et al. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving? Human Gene Therapy Clinical Development. 2017;28(3):126-135. doi:10.1089/humc.2016.193
Borysowski J, Wnukiewicz-Kozłowska A, Górski A. Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials. British Journal of Clinical Pharmacology. 2020;86(4):679-686. doi:10.1111/bcp.14223
Bowen AE, Nargundkar S. Drug development for rare diseases: a case for patient-centricity, equity, and access to clinical trials. J Rare Dis. 2025;4(1):15.
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Buechner B. Compensation for Injured Study Subjects in Clinical Trials: An Ethical Obligation in Human Subjects Research. Food & Drug LJ. 2012;67(3):363-372.
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Cavagnaro J, Silva Lima B. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products. European Journal of Pharmacology. 2015;759:51-62. doi:10.1016/j.ejphar.2015.03.048
Cave E. EU Clinical Trials Regulation 2014: Fetter Or Facilitator. Med L Int’l. 2018;18(2-3):179-194.
Cheynet de Beaupré, A. CRISPR Cas9 : modifier le génome humain. Revue Juridique Personnes et Famille 2018, No. 6.
Choi R. Increasing Transparency of Clinical Trial Data in the United States and the European Union Notes. Wash U Global Stud L Rev. 2015;14(3):521-548.
Cohen-Haguenauer O. A Comprehensive Resource on EU Regulatory Information for Investigators in Gene Therapy Clinical Research and Advanced Therapy Medicinal Products. Human Gene Therapy. 2013;24(1):12-18. doi:10.1089/hum.2012.2525
Costanzo CD. The Problematic Path of Fundamental Rights in the European Union: Continuing the Journey on the Regulation on Clinical Trials. European Journal of Health Law. 2022;30(1):50-65. doi:10.1163/15718093-bja10089
De A, Lohani A. Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review. Ther Innov Regul Sci. Published online October 7, 2025:1-18. doi:10.1007/s43441-025-00871-2
de Jong AJ, Gardarsdottir H, Santa-Ana-Tellez Y, de Boer A, Zuidgeest MG. Experiences with low-intervention clinical trials—the new category under the European Union Clinical Trials Regulation. Clinical Trials. 2025;22(4):494-500. doi:10.1177/17407745241309293
de Jong AJ, van Rijssel TI, Zuidgeest MGP, et al. Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective. Clinical Pharmacology & Therapeutics. 2022;112(2):344-352. doi:10.1002/cpt.2628
de Jong AJ, Zuidgeest MGP, Santa-Ana-Tellez Y, et al. The impact of operational trial approaches on representativeness: Comparison of decentralized clinical trial participants, conventional trial participants, and patients in daily practice. Drug Discovery Today. 2025;30(2):104304. doi:10.1016/j.drudis.2025.104304
de Jong AJ, Santa-Ana-Tellez Y, van Thiel GJMW, et al. COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union. Clinical Pharmacology & Therapeutics. 2021;109(6):1517-1527. doi:10.1002/cpt.2225
de Morpurgo M. Italy Reforms Clinical Trial Rules Reports: Italy. EPLR. 2018;2(1):32-36. doi:10.21552/eplr/2018/1/7
de Morpurgo M, Busani C. New Clinical Trial Rules in the EU: A Practical Overview of the Upcoming Regulation Reports. EPLR. 2021;5(3):129-137.
De Paola E, Del Bono L, Dri DA, et al. Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change. Front Pharmacol. 2025;16:1-16. doi:10.3389/fphar.2025.1661186
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Denoël C, Trebuchet G. Les limites imposées à la recherche médicale. Petites Affiches. 2015;(207):16.
Desmoulin-Canselier S. L’évaluation des médicaments à l’ère de la médecine des données. RDSS | Dalloz. 31/122018;(6):1043-1054.
Detela G, Lodge A. EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation. Molecular Therapy Methods & Clinical Development. 2019;13:205-232. doi:10.1016/j.omtm.2019.01.010
DeVito NJ, Goldacre B. Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study. Clin Trials. 2022;19(2):172-183. doi:10.1177/17407745211073483
Dezeuze E, Bianchi J. Obligation de communiquer « dès que possible » l’information privilégiée relative à l’existence d’un décalage du calendrier prévisionnel portant sur des essais cliniques – La Base Lextenso. BJB. 2020;118(1):27.
Djurisic S, Rath A, Gaber S, et al. Barriers to the conduct of randomised clinical trials within all disease areas. Trials. 2017;18(1):360. doi:10.1186/s13063-017-2099-9
Egger GF, Herold R, Rodriguez A, Manent N, Sweeney F, Saint Raymond A. European Union Clinical Trials Register: on the way to more transparency of clinical trial data. Expert Rev Clin Pharmacol. 2013;6(5):457-459. doi:10.1586/17512433.2013.827404
Elsäßer A, Regnstrom J, Vetter T, et al. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency. Trials. 2014;15(1):383. doi:10.1186/1745-6215-15-383
Faccin F, Tebbey P, Alexander E, Wang X, Cui L, Albuquerque T. The design of clinical trials to support the switching and alternation of biosimilars. Expert Opinion on Biological Therapy. 2016;16(12):1445-1453. doi:10.1080/14712598.2017.1238454
Faltus T. Medicinal Genome Editing in Germany – Tensions between Safeguarding and Circumventing Ethical and Legal Standards, ILR Special Issue. Loy LA Int’l & Comp L Rev. 2019;43(3):227-250.
Faltus T, de Miguel Beriain I. The EU legal framework on clinical trials directed to therapeutic germline gene alteration: A critical and systematic analysis. Medical Law International. 2023;23(1):44-70. doi:10.1177/09685332231154586
Feigal EG, Tsokas K, Viswanathan S, et al. Proceedings: International Regulatory Considerations on Development Pathways for Cell Therapies. STEM CELLS Translational Medicine. 2014;3(8):879-887. doi:10.5966/sctm.2014-0122
Fichet C. L’évolution législative et réglementaire de la recherche biomédicale ou la promotion de l’innovation dans un cadre protecteur et transparent. Les Petites Affiches. 2008;(124):5.
Flear ML. The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health. Journal of Medical Ethics. 2016;42(3):192-198.
Fox AW. Where is European Regulation 536/2014 Taking Us? Pharm Med. 2023;37(5):343-347. doi:10.1007/s40290-023-00487-7
Gálvez Martín P, Clares Naveros B, Hmadcha A, Ruiz-Martínez A, Soria Escoms B. Development of a cell-based medicinal product: Regulatory structures in the European Union. Published online November 25, 2012. doi:10.13039/501100011011
Gaumont-Prat H. Droit des produits de santé : bilan 2015. Les Petites Affiches. 2016;(117y9):3.
Gaumont-Prat H, Bévière-Boyer B, Dieny E, Laigneau JF, Lunel A. Droit des produits de santé : actualités de l’année 2016 (2e partie) -. Les Petites Affiches. 2017;(127):7.
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Gennet É, Andorno R, Elger B. Does the new EU Regulation on clinical trials adequately protect vulnerable research participants? Health Policy. 2015;119(7):925-931. doi:10.1016/j.healthpol.2015.04.007
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Giannuzzi V, Altavilla A, Ruggieri L, Ceci A. Clinical Trial Application in Europe: What Will Change with the New Regulation? Sci Eng Ethics. 2016;22(2):451-466.
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Ginn SL, Mandwie M, Alexander IE, Edelstein M, Abedi MR. Gene therapy clinical trials worldwide to 2023—an update. The Journal of Gene Medicine. 2024;26(8):e3721. doi:10.1002/jgm.3721
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