Considerations for crucial elements in early clinical research and development of anti-tumor drug combination therapy
Combination therapy is essential for anti-tumor drugs to increase efficacy and overcome drug resistance.With the emergence of new anti-tumor drugs,there are more and more combinations of the different mechanisms of action and types of drugs.Critical elements of clinical research,such as subject population and delivery strategies,may be adjusted when expanding from a single drug to combination therapy.Therefore,exploring how to improve the probability of successful critical registration studies in the early stages of drug clinical research has always been a concern.This article combines the past review experience to elaborate on how to consider key points in early clinical research of combination drugs,providing a reference for enterprise research and development.