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Exploring Novel Clinical Trial Designs for Gene-Based Therapies - Proceedings of a Workshop (Paperback)
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Exploring Novel Clinical Trial Designs for Gene-Based Therapies - Proceedings of a Workshop (Paperback)
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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 Contents Front Matter 1 Introduction and
Overview 2 Developing First-in-Human Gene Therapy Clinical Trials 3
Understanding the Complexities of Patient Selection, Enrollment,
and the Consent Process 4 Developing Endpoints for Gene Therapy
Clinical Trials 5 Integrating Gene-Based Therapies into Clinical
Practice: Exploring Long-Term Clinical Follow-Up of Patients 6
Reflections on the Workshop and Potential Opportunities for Next
Steps References Appendix A: Workshop Agenda Appendix B: Speaker
Biographical Sketches Appendix C: Statement of Task Appendix D:
Registered Attendees
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