Design and Conduct of Clinical Trials
Table Of Content Avoiding designing failed clinical trials: main issues that lead to invalid data Types of Trial Designs Choosing the appropriate phase design Design and Interpretation of Clinical Trials Clinical trial phases: pharmacological studies Case‐control studies based within a defined cohort Failed (invalid) clinical trials vs. negative (but valid) clinical trials Below, we created a framework based on the risk that the trial will fail vs. the chance that results will be beneficial to help the investigator choose the appropriate phase design. This week, we explore different types of trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs. (i) Switch back design (ABA vs BAB arms) – Drug A → Drug B → Drug A in one arm versus Drug B → Drug A → Drug B in other arm. The switch back and multiple switchback designs are of emerging relevance with the advent of biosimilars where switchability and in...