Early phase-clinical trials are a starting point for researchers who are studying a new treatment therapy. Who will make up the target population to measure the new treatment? Should recently diagnosed patients be the target group or should it be patients in advanced stage? Who has the greatest opportunity cost? Are patients in advanced stage past the point of benefiting from the new therapy? Should the research strategy focus on minimizing benefits slowly lessoning the risks to patients or should the maximum level be tested to quickly establish a therapeutic treatment? The authors of the article The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials by Spencer Phillips Hey and Jonahtan Kimmelman contrast strategies in developing early-phase clinical trails and discuss the intricate dynamics in developing a protocol for an early-phase clinical trial.
The authors begin by outlining key components of early-phase trials. They argue the best approach will “optimize various components of a potential therapy so that subsequent confirmatory trials have the maximal probability of informing later drug development a clinical care.” They explain that in order to identify a successful therapy a researcher must identify the agent in the disease process followed by the development…show more content… For example the only known drug to treat ALS showed absolutely no effects when tested in mice models. The goal of early-phase clinical testing is to find a successful combination of therapy to be further tested. Researchers refer to this magical combination of “preparations, doses, surgical methods, immunosuppressive regimes, and co-interventions” as an “intervention ensemble.” In the search for the successful combined therapy, the authors mostly support the risk-escalation strategy however they agree there are times that warrant the use of innovative care strategy (maximum
