NIH VideoCast - Clinical Trial Designs for Emerging Infectious Diseases - Breakout Session (Day 2)

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Clinical Trial Designs for Emerging Infectious Diseases - Breakout Session (Day 2)

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Air date:	Tuesday, November 10, 2015, 8:00:00 AM Time displayed is Eastern Time, Washington DC Local
Views:	Total views: 193 (59 Live, 134 On-demand)
Category:	Conferences
Runtime:	03:53:13
Closed captioning:	Check box to display CC outside of the video Note: You can drag the captioning window around and resize it
Description:	The Ebola Virus Disease (EVD) epidemic has highlighted the importance of being able to rapidly evaluate investigational products during a public health emergency, including in resource limited settings. It is generally agreed that access to early investigational interventions that have not yet been well characterized should be provided in a setting that allows for the reliable assessment of benefits and harms. Ascertaining the safety and efficacy of an investigational product is an important step that is necessary to protect and promote the public health now and in the future. A critical aspect of the response effort is the ability to rapidly establish and conduct clinical trials that are both scientifically valid and ethically appropriate. During the course of the EVD epidemic, there has been significant debate over the design of trials to evaluate investigational therapies and vaccines. Among the trial designs employed during the EVD epidemic to evaluate experimental therapeutics were (1) open-label product administration compared to historical controls, and (2) randomized open-label product administration compared to concurrent “standard of care” controls. Among the proposed trial designs for EVD vaccines are (1) randomized controlled trials, (2) clustered randomized trials, (3) stepped wedge trials, and (4) ring vaccination trials. Trials to support alternative licensure pathways under FDA regulations, such as accelerated approval or the animal rule, have also been proposed. Advocates cited a range of scientific, ethical and practical concerns for and/or against each of these (and other) trial designs for investigational products. Based on our experience, positive and negative, in designing and conducting clinical trials for EVD, it is important to bring the various stakeholders together to explore the lessons learned, and how we may be better prepared to deploy investigational products in the setting of the next epidemic of an emerging infectious disease (EID).

NLM Title:	Clinical trial designs for emerging infectious diseases / FDA.
Author:	Clinical Trial Designs for Emerging Infectious Diseases (Workshop) United States. Food and Drug Administration,
Publisher:
Abstract:	(CIT): The Ebola Virus Disease (EVD) epidemic has highlighted the importance of being able to rapidly evaluate investigational products during a public health emergency, including in resource limited settings. It is generally agreed that access to early investigational interventions that have not yet been well characterized should be provided in a setting that allows for the reliable assessment of benefits and harms. Ascertaining the safety and efficacy of an investigational product is an important step that is necessary to protect and promote the public health now and in the future. A critical aspect of the response effort is the ability to rapidly establish and conduct clinical trials that are both scientifically valid and ethically appropriate. During the course of the EVD epidemic, there has been significant debate over the design of trials to evaluate investigational therapies and vaccines. Among the trial designs employed during the EVD epidemic to evaluate experimental therapeutics were (1) open-label product administration compared to historical controls, and (2) randomized open-label product administration compared to concurrent "standard of care" controls. Among the proposed trial designs for EVD vaccines are (1) randomized controlled trials, (2) clustered randomized trials, (3) stepped wedge trials, and (4) ring vaccination trials. Trials to support alternative licensure pathways under FDA regulations, such as accelerated approval or the animal rule, have also been proposed. Advocates cited a range of scientific, ethical and practical concerns for and/or against each of these (and other) trial designs for investigational products. Based on our experience, positive and negative, in designing and conducting clinical trials for EVD, it is important to bring the various stakeholders together to explore the lessons learned, and how we may be better prepared to deploy investigational products in the setting of the next epidemic of an emerging infectious disease (EID).
Subjects:	Clinical Trials as Topic Communicable Diseases, Emerging--drug therapy Hemorrhagic Fever, Ebola--drug therapy Therapies, Investigational
Publication Types:	Congress Webcast

NLM Classification:	WC 100
NLM ID:	101673101
CIT Live ID:	17601
Permanent link:	https://videocast.nih.gov/watch=17601

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