Expanding government and payer requirements for additional data on products, whether for safety monitoring, efficacy confirmation or economic and clinical value evaluation, underscore the importance of an integrated strategy for investigator initiated trials (IIT) and real world evidence (RWE) research. In developing an IIT/RWE strategy, companies need to be clear up front about why specific research should be supported, and use this criteria to decide which studies have the potential to be valuable. Determining how and where to use IITs and RWE requires clear objectives for the research and coordinated organizational capabilities.
Investigator Initiated Trials continue to play a critical role for pharma and medical device companies. Companies use IITs to further research in areas of interest and develop insights into product effectiveness with patient populations. These studies are also used to support development of new and existing product lines, improve safety, and provide insights into product effectiveness with specific patient populations.