What is an investigator-initiated study (IIS)?
An IIS is a study where the concept, design, and execution are driven by a healthcare professional or academic researcher, rather than the sponsoring pharmaceutical company. Companies may support these studies with funding, study drugs, or data, but the investigator retains control over the research.
Why are IISs important in medical affairs and evidence generation?
IISs contribute to scientific credibility, address real-world questions, and support broader data generation. They help fill evidence gaps, explore new indications, and foster trusted partnerships with clinical leaders. IISs also complement company-sponsored research by providing additional perspectives on product value.
