Your browser doesn't support javascript.
loading
Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe.
Kallio, Marko J; Starokozhko, Viktoriia; Agricola, Eleonora; Burggraf, Manja; Heß, Anne; Ballensiefen, Wolfgang; Löbker, Wiebke; Nuevo, Yoana; Pasmooij, Anna M G; Mol, Peter G M.
Afiliação
  • Kallio MJ; Finnish Medicines Agency, Helsinki, Finland.
  • Starokozhko V; Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
  • Agricola E; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
  • Burggraf M; Italian Medicines Agency, Rome, Italy.
  • Heß A; Paul Ehrlich Institute, Langen, Germany.
  • Ballensiefen W; Federal Institute for Drugs and Medical Devices, Bonn, Germany.
  • Löbker W; German Aerospace Center, Project Management Agency, Health, Innovation for Disease Related Research and Personalised Medicine, Bonn, Germany.
  • Nuevo Y; Federal Institute for Drugs and Medical Devices, Bonn, Germany.
  • Pasmooij AMG; Spanish Agency of Medicines and Medical Devices, Madrid, Spain.
  • Mol PGM; Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
Clin Pharmacol Ther ; 113(2): 349-359, 2023 02.
Article em En | MEDLINE | ID: mdl-36326573
Important discoveries by academic drug developers hold the promise of bringing innovative treatments that address unmet medical needs to the market. However, the drug development process has proved to be challenging and demanding for academic researchers, and regulatory challenges are an important barrier to implementing academic findings in clinical practice. European regulators offer varying degrees of support services to help drug developers meet regulatory standards and requirements. "Strengthening Training of Academia in Regulatory Sciences and Supporting Regulatory Scientific Advice" (STARS) is a European Commission-funded consortium aiming to strengthen the training of academics in regulatory science and requirements. Here, we report the results of four surveys that investigated the awareness and utilization of support tools offered by European regulators and identified the regulatory challenges and support needs of researchers. The surveys targeted four main European stakeholders in academic medicines research: academic research groups (706 respondents), academic research centers (99), funding organizations (49), and regulators (22). The results show that while European regulators provide various regulatory support tools, less than half of the responding academic researchers were aware of these tools and many experienced challenges in reaching a sufficient level of regulatory knowledge. There was a general lack of understanding of the regulatory environment that was aggravated by poor communication between stakeholders. The results of this study form a foundation for an improved European medicines regulatory network, in which regulatory challenges faced by academia are tackled.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Controle de Medicamentos e Entorpecentes / Descoberta de Drogas Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Controle de Medicamentos e Entorpecentes / Descoberta de Drogas Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article