Updated: Oct 21
A coaching client recently asked the question “What is the role of the MSL in investigator initiated studies?”
If you read any job description for an MSL role, they will list responsibilities such as;
“facilitation of the investigator sponsored trials process”
“Work as a team to assist in set-up, implementation and execution of company-sponsored local clinical studies”
But what does this actually mean for the MSL?
Put simply, the role of the MSL in managing investigator initiated studies can be broken down into three steps;
1. Assess the Feasibility
The MSL must identify data gaps (i.e. understand what kind of data KOLs would like to see and also what data would be of strategic value to the company).
Then the MSL will sssess the suitability of KOLs who can be principal investigator on the study. These KOLs must have a lot of experience and a great reputation so they can design a robust study.
If a KOL submits a proposal for a study and it is of strategic value and the KOL is a suitable lead investigator, the next step is for the MSL to work with the KOL to finalise the study proposal.
2. Facilitate Submission & Approval of the study
The MSL must then work with the internal team (which includes other members of the medical team, and may include members of the marketing, regulatory affairs, clinical teams) to get study approved.
The MSL then develops milestones for the study and liaises with the KOL regarding milestones e.g. Milestone 1: 50% of patients recruited by the end of Q1 2020.
3. Serve as the primary liaison between the company and investigators from inception to publication
The MSL maintains regular communication with the KOL study lead to ensure the study is on track.
The MSL develops a data dissemination plan - when the study is complete, what conferences will the data be presented at? What journal will it be submitted to? What other KOLs can you share the data with once it is published?
For more information how to perform typical MSL activities, or to learn more about the MSL role, get in touch via email@example.com for 1:1 coaching.