What can KOLs add to your Clinical Investigation?
Key opinion leaders (KOLs) are experts and thought leaders in their field. They are an important resource for R&D, market access and clinical investigations. KOLs can add great value to your clinical investigation by helping you develop a credible study protocol with scientifically relevant outcomes. Prior and during the clinical investigation A KOL in the role of Principal Investigator can motivate other Investigators and boost enrollment. Their podium presence and influence on peers can be invaluable for dispersing study outcomes and advocating your medical device in the medical community at local, regional or even global levels.
What are risks and limitations when engaging KOLs for Clinical Investigations?
It is crucial to identify high-performing study sites to make a trial a success. But a good KOL is not necessarily a high enroller. Sponsors focusing only on KOLs as Investigators for their study must be aware that enrollment may not be optimal. It may also be challenging to get all the KOLs to work together efficiently as they often have conflicting or competing interests. In multicenter trials it is therefore essential to engage the right mix of Investigators and to add KOLs selectively. In single center trials the KOL must also have acceptable access to the target patient population, and ideally, he or she can delegate some of the day-to-day study responsibilities to local co-investigators.
How can Qserve help you?
Protocol development, site selection and site management are often outsourced to a CRO. Most of the times these activities involve interactions with KOLs. A good CRO will interact with your KOL carefully. They will approach them as a partner and acknowledge the KOL’s time, opinion and scientific expertise, while keeping the study strategy aligned with the Sponsor’s priorities and needs. At Qserve, we are ready to help you identify the right KOLs for your study and to foster those valuable KOL relationships.
Are you interested in attending our ISO14155 training? On the 18th and 19th of February 2019 you are very welcome in Amsterdam for a 2-day training.
Do you want to be trained on shorter notice? Or do you prefer an in-house training for your team? Contact us to discuss the options.
Wiebe Postma