Name: Exploring Novel Clinical Trial Designs for Gene-Based Therapies. Proceedings of a Workshop
SKU: 64826299
Price: 955.00 MXN
Availability: InStock
Author: Board on Health Sciences Policy;Siobhan Addie;Sarah H. Beachy;Meredith Hackmann;Joe Alper;Health and Medicine Division;Forum on Regenerative Medicine;Engineering, and Medicine National Academies of Sciences
ISBN: 9780309672986

portada Exploring Novel Clinical Trial Designs for Gene-Based Therapies. Proceedings of a Workshop

Exploring Novel Clinical Trial Designs for Gene-Based Therapies. Proceedings of a Workshop

Formato

Libro Físico

Editorial

National Academies Press

Autor

Board on Health Sciences Policy;Siobhan Addie;Sarah H. Beachy;Meredith Hackmann;Joe Alper;Health and Medicine Division;Forum on Regenerative Medicine;Engineering, and Medicine National Academies of Sciences

Año

2020

N° páginas

126

Encuadernación

Tapa Blanda

Dimensiones

22.9x15.2x2.5 cm

ISBN13

9780309672986

Exploring Novel Clinical Trial Designs for Gene-Based Therapies. Proceedings of a Workshop

Board On Health Sciences Policy;Siobhan Addie;Sarah H. Beachy;Meredith Hackmann;Joe Alper;Health And Medicine Division;Forum On Regenerative Medicine;Engineering, And Medicine National Academies Of Sciences (Autor) · National Academies Press · Tapa Blanda

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Reseña del libro "Exploring Novel Clinical Trial Designs for Gene-Based Therapies. Proceedings of a Workshop"

Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop. Table of ContentsFront Matter1 Introduction and Overview2 Developing First-in-Human Gene Therapy Clinical Trials3 Understanding the Complexities of Patient Selection, Enrollment, and the Consent Process4 Developing Endpoints for Gene Therapy Clinical Trials5 Integrating Gene-Based Therapies into Clinical Practice: Exploring Long-Term Clinical Follow-Up of Patients6 Reflections on the Workshop and Potential Opportunities for Next StepsReferencesAppendix A: Workshop AgendaAppendix B: Speaker Biographical SketchesAppendix C: Statement of TaskAppendix D: Registered Attendees