Software to calculate doses for more effective and safe clinical trial design.
- Intuitive, user-friendly software design.
- Flexible parameter inputs and easily interpreted results.
- Provides simulations to estimate recommended maximum tolerated dose (MTD).
Before entry to commercial market, novel therapeutics must be examined in clinical trials to assess not only their efficacy but also potential adverse events (AE). Phase I clinical trials require studying the therapeutic in healthy subjects to minimize potential risks for studied individuals. However, in clinical cancer care, combinations of complex factors such as the gap in knowledge of pathogenesis and the limited repertoire of approved agents can result in many patients achieving only suboptimal responses to standard therapy. As a result, people often turn to experimental clinical trials as last resorts. Phase I cancer clinical trials also bear additional therapeutic purposes. The accuracy of dose finding as well as rapidity of dose-escalation are two of the biggest goals and metrics when developing and examining clinical trial design performance.
Emory University researchers have developed software focused on state-of-the-art clinical trial design, Escalation with overdose control (EWOC), combined with novel quasi-continuous toxicity metric system, Normalized Equivalent Toxicity Score (NETS). This software makes EWOC-NETS more accessible and applicable for all clinicians by creating a user-friendly and intuitive system that allows flexible parameter inputs and generates easily interpreted results. Physicians can also perform simulations using different toxicity scenarios to estimate the recommended maximum tolerated dose (MTD). Equipped with this robust and intuitive software, clinicians will be able to make their own Phase I Cancer Clinical Trials more efficient and accurate with minimum assistance from statisticians.
Software package in preparation.