Traditionally, MSLs are deployed 24 to 12 months prior to a new product launch. Several smaller as well as larger pharmaceutical companies have come to the conclusion that it would be very valuable to deploy MSLs in their late-stage clinical trials even earlier. Some large companies even have pipeline MSLs that are solely responsible for working in clinical development to support and identify trial sites. Reports of the MSL society also show a general industry trend to an earlier deployment of MSLs (36 % in phase II, 46 % in phase III) in clinical trials.1
To my knowledge, there are no peer-reviewed papers or concrete data on how much value an MSL can bring in clinical trials (e.g., how many or how much faster patients were enrolled) also because this is a concerted effort of the clinical operations team. But there are anecdotal reports about that and often Medical Affairs (MSLs) are called into clinical trials when patient recruitment is lagging behind expectations. This indicates that Medical Affairs can help with patient enrolment. There is also some data available that Investigators with a positive sponsor “Experience” enroll twice as many patients in clinical trials.2 Having a trusted partnership between an MSL and an investigator clearly fosters that. In addition in some therapeutic areas like oncology, there is competition for patients to be enrolled in clinical trials where this partnership could also bring value.
I believe that MSLs are in a unique position to interact with investigators with their deep knowledge of science, the disease, the mode of action, and the available clinical data as well as pipeline knowledge. Upon unsolicited requests or if a confidentiality agreement is in place (which is mostly the case with investigators) they can also discuss available clinical data on the molecule as well as on the pipeline which is of interest for investigators. The main activities of MSLs in clinical trials besides building a trusted partnership would be site/investigator recommendation (84 %), site education (47 %), and investigator meetings (52 %).3
MSLs can build partnerships and advocacy and bring back insights on clinical trial designs, patient experiences, and unmet medical needs to R&D and Medical Affairs. In addition, they can relate site questions and concerns to the respective CRA to enhance patient enrolment. Another activity could be the training of the study team on the new molecule. Armed with this knowledge and the partnership built with investigators they are in an optimal position to move on to reach out to other external experts beyond clinical trial sites and start into the pre-launch phase. The building of trust and partnership with investigators could also create value in the pre and post-launch phase if the investigators share their hands-on knowledge and experience with the new molecule and potentially advocate for it.
The profile of an MSL is complementary to those of CRAs (site primary contact, site training, initiation, monitoring and closeout, trial master file maintenance) or clinical trial educators (Supporting the recruitment plan and the CRA, tracking and reporting site recruitment, optimizing referral and trial awareness) with little overlap. Good communication and understanding of the different profiles and tasks and close collaboration and alignment are still mandatory.
These findings and arguments make a compelling case for an early deployment of MSLs in clinical trials before engaging in a pre-launch setting.
There are still some open questions such as how to concretely measure the value of the MSL deployment versus other clinical functions such as CRAs and clinical trial educators. Another thought is that clinical trial educators might be a great source of talent for future MSLs given the right academic credentials.
Another obstacle is obviously the budget needed for a very early deployment of MSLs. Depending on the owner of the payroll there might be little appetite for an affiliate to deploy FTEs several years before a launch. Understanding and communication of the value of MSLs in clinical trials are critical and conversations with R&D or regional or global Medical Affairs organizations may also be a solution if there is willingness to split or take over costs.
1 MSL Society Report: 2021 Launching an MSL Team: When to Begin Hiring and Determining Team Size
2 KC George et al. “The Clinical Trial Challenge: To Win Patients, Win Over Physicians” (2022) Website Bain & Company; https://www.bain.com/insights/the-clinical-trial-challenge-to-win-patients-win-over-physicians/
3 E. Diaz et al. “MSL and CRA: A Responsibility Model for the Efficiency of Clinical Research and Clinical Trials” The MSL (2020)
About the author:
Reinhard Berkels, PhD
Reinhard has more than 17 years of Medical Affairs experience in the pharmaceutical industry, holding country-level, regional, and global roles. He has successfully covered all facets of Medical Affairs, including launch readiness, digital transformation, RWE generation, medical education, MSL excellence, and medical strategy, and was responsible for leading Medical Affairs teams with direct accountability to senior management.
Reinhard has a broad knowledge of healthcare ecosystems and deep therapy area expertise spanning cardiology, neurology, and immunology. Prior to his current role as Head of Medical Affairs Strategy at IQVIA and before moving into Medical Affairs, Reinhard gained experience in drug discovery and pre-clinical development in the pharmaceutical industry.
He holds a PhD degree in Biology from the University of Cologne and is a lecturer (Privat-Dozent) for Pharmacology at the University Clinic of Cologne.