SYNERGY Investigator-Sponsored Research

Expanding Clinical Knowledge with Investigator-Sponsored Research

The Role of Investigator-Sponsored Research in the SYNERGY Clinical Program

CMO Craig Thompson Shares the Unique Role of ISRs in the SYNERGY Program

“Investigator-sponsored research (ISR) is a key way in which Boston Scientific supports the interventional cardiology scientific community, enabling top clinician investigators to pursue answers to important unresolved questions in cardiovascular medicine. We are especially excited about the enormous amount of data arising from Investigator-Sponsored Research around the globe in over 20,000 SYNERGY patients, evaluating everything from DAPT duration to vessel healing. These ISRs provide robust, complementary support to the Boston Scientific sponsored EVOLVE II pivotal and post market trials, and contribute to the most comprehensive dataset we have ever had surrounding a single device.”

Dr. de la Torre Hernandez Shares his Perspective as an ISR Investigator

Following his recent on-line ISR publication using OCT to assess healing at 3 and 6 months post-implant of the SYNERGY Stent, Dr. de la Torre Hernandez shares his thoughts on the impact of ISRs for the field of interventional cardiology.

“Investigator-sponsored research (ISR) is becoming more common in recent years. The most important reason for this is the fact that industry-promoted pivotal trials cannot practically be designed to evaluate every potential clinical scenario and therefore cannot provide all-encompassing data for any given medical device. ISRs allow physician researchers to evaluate additional clinical scenarios and potential indications for existing devices adding a powerful complement to the industry provided data. To remain truly independent and unbiased, it is important that the proposal of an ISR be based on objective criteria such as the credentials of the investigator, whether or not the study meets an unmet clinical need, the quality of the study design, and finally the cost of the research should be reasonable. My personal experience as an investigator involved in ISR projects has been very positive as I feel that ISRs are a win-win for companies, physicians, and most importantly, for the patients.”