Recurring trends and deficiencies with clinical trial applications

First-in-human and early phase clinical trials must meet a wide range of criteria. They must be scientifically justified and clearly designed. They must consider the patient population involved and their needs, including safeguarding patients and ensuring proper oversight. Regulators are looking for clear scientific rationale and robust justification on dose escalation and dosing strategy, they […]

Understanding the stumbling blocks: Common RFIs during early clinical trial applications

Why do sponsors receive requests for information (RFIs) during a clinical trial application (CTA)? What are the stumbling blocks and the most common queries? And what do these requests from the regulators mean for sponsors? These are some of the questions that IDEA Regulatory set out to chart and understand when we conducted an analysis […]