An alternative to a placebo control group is the use of existing medical history information on a group of similar patients to provide a historical control.
TORONTO (PRWEB) February 27, 2020
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Rare disease clinical trials have several challenges that make them more difficult to conduct than clinical trials for more common diseases. Small patient populations, pediatric populations and the desire by patients and their caregivers to receive active therapy while on a clinical trial make it much more likely that rare disease trials will be conducted without placebo control groups. An alternative to a placebo control group is the use of existing medical history information on a group of similar patients to provide a historical control.
Recent developments by regulatory agencies have resulted in increasing use of historical control groups to provide comparative evidence to establish the efficacy and safety of rare disease therapies. This webinar provides an overview of the use of historical control populations in rare disease drug development and approval.
Join William C Maier, MD, PhD, Chief Scientific Officer and Head of Rare Disease Research, Commercialisation and Outcomes Services at ICON in a live webinar on March 12, 2020 at 11am EDT (NA) (3pm GMT/UK) to learn about the challenges and opportunities of this approach, including:
- Sources for historical control information, including prospective and retrospective data
- The advantages and implications on study enrollment, study budget and time to market
- How to identify and address data consistency, quality and outcomes assessment methods
- The current regulatory landscape in the US and Europe and a review of recent approvals using historical controls
For more information or to register for this event, visit Using Historical Controls in Rare Disease Clinical Trials: Challenges and Opportunities.
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