The Benefits & Challenges Of Head-To-Head Trials

By Ed Miseta, Chief Editor, Clinical Leader

Drug development generally takes a pretty standard path from discovery to commercialization. Preclinical testing leads to safety and efficacy testing in Phase 1 and Phase 2 trials. Those studies lead to a larger Phase 3 that generates data necessary to secure a regulatory approval. But there is an additional path sponsors can take that is known as head-to-head trials (H2H). These studies test your medicine against others that are already on the market, and can determine if your treatment is a better option for patients.