The 2017 Medical Affairs Advancement Forum took place in Philadelphia January 30th and 31st. Many timely topics were discussed but much of the focus was on the evolving roles undertaken by medical affairs and associated compliance issues.
Two key discussion areas were:
- Collaborations between medical affairs and commercial functions and the compliance challenges they face. The agreed solution was that medical affairs and commercial should develop SOPs to clearly separate scientific exchange and promotional related activities.
- Measuring the value of medical affairs using metrics such as number of publications or subscription downloads, and compliance issues in achieving their goals. The conclusion was that medical affairs should strive to achieve their missions related to these metrics only, and not sales targets.
Polaris partner, Darren Jones, hosted a session on the role of MSLs (Medical Science Liaisons) in cultivating KOL (Key Opinion Leader) relationships, and managing the risks of collaborative research. Darren shared his extensive insights regarding the balance of responsibilities between MSLs and the investigators over the course of different phases of an investigator initiated study.
An investigator initiated research study can be grouped into five phases:
1) Cultivation of the research concept,
2) Protocol development,
3) Grant review and contracting,
4) Start-up and ongoing performance of the study, and
5) Study completion and publication.
During the first phase, MSLs may foster routine medical information exchanges with the potential investigators, but they cannot sell or outsource the manufacturer’s own research ideas. If physicians are trying to further their own scientific knowledge that is acceptable. However, the MSL needs to frame the response that this information is being provided for medical information/education purposes for the physician and is not intended to be used to for the development of other research concepts.
After investigators create their own research concept, they should be able to develop the protocol independently without MSLs’ involvement. Also, they should not be paid to write the protocol because it is important that no promise of protocol approval be conveyed. Manufacturers should have policies and procedures requiring that MSLs may not direct, control, or unduly influence development and approval of IIR proposals/protocols.
Once a grant is submitted, reviewed and potentially approved, MSLs should not be involved in the payment cycle and should not deliver the contract. The MSLs’ primary mission and objective remains the management of the KOL relationship, and not the management of the grant. MSLs, however, may require investigator’s written progress reports as a mechanism for overseeing the fiscal aspect of the study. As a support for the on-going performance of the study, MSLs can provide all the information related to patient safety to the investigators.
Finally, upon study completion, publications should be written by the investigators, and the MSLs must be “hands-off,” since they are not the sponsors of the study. On the other hand, MSLs should not prevent investigators from publishing negative findings nor adverse event reporting.
As a closing remark, Darren stressed that MSLs should review investigator’s budget proposals early on, before its approval, and ensure that the investigator is paid according to a pre-set rate structure based on a proper FMV analysis. He also compared the MSL’s responsibilities in IIR to outcomes research, where MSLs may appropriately play a bigger part and can be more engaged throughout the course of the research.