Randomized controlled trials are the gold standard for establishing efficacy in any clinical development program, but there are sometimes challenges with recruiting and retaining the number of patients needed for these trials, particularly in certain rare oncology indications where the patient pool is small, or when patients and clinicians view randomizing to control therapy as unacceptable.
This webinar will discuss possible methods for reducing the number of patients needed for the study, and even removing the need for a control arm. These methods include comparison to well-matched groups of control patients from historical clinical trials and using simulation to predict what would have happened to patients if they had been assigned to a control arm.
Discussion Points
In this webinar, we will discuss:
- Options for creating a scientifically valid external control in an effort to reduce the number of patients required in a clinical study
- Considerations for choosing the right option
- Relevance to oncology studies
Key Learning Objectives
Attendees of this webinar will:
- Understand the options and considerations in creating a valid external control
- Understand the benefits, and limitations, of simulation in clinical trials
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