It’s now accepted that there are enormous benefits to consulting with patients and sites when designing your clinical trial and preparing your protocol. Pitfalls are avoided, burden is reduced, and potential recruitment barriers are alleviated.
The only drawback is that in the same way that sponsors may not always fully grasp the challenges faced by sites and patients, the reverse is also true. Sites and patients, understandably, won’t always comprehend the operational or regulatory constraints faced by the sponsor.
To help overcome this gap in understanding, sponsors should take advantage of a resource available within their own organization that has an informed view over the full product life cycle, spanning early development, pre-launch, launch, and post-launch – Medical Science Liaisons (MSLs). Through their daily work, MSLs build up a deep appreciation of the needs of site staff and patients, regulatory concerns, and commercial imperatives. Seeking their advice is a smart move.
The MSL (also known as medical liaison, clinical medical liaison, or regional science manager) is a cornerstone in the medical science community. These individuals are scientifically trained therapeutic specialists who are able to communicate complex scientific information to various stakeholders.
First introduced in 1967 by Upjohn Pharmaceuticals, today’s MSL holds a doctorate such as M.D., PharmD, or Ph.D. in a prominent life science field, and may specialize in specific therapeutic disciplines.
The Medical Science Liaison Society describes MSLs as vital to a company's success – they act as scientific peers for medical practitioners and the pharmaceutical industry alike.
The dominant role of an MSL is to build relationships with key opinion leaders (KOL) in a distinct therapeutic category. They provide a source of credibility to external parties to bridge the gap between product development and commercial success. MSLs also have an evolving role in the clinical trial process and in managing trial complexities.
How Do MSLs Contribute to Product Development?
The MSL stays involved throughout the product’s lifecycle with roles in the various stages:
- Early development through pre-launch: MSLs reach out to the medical community to generate interest and to provide feedback to the development team. The MSL works with opinion leaders to ensure they understand the product and build awareness about key aspects of trial execution.
- Launch: MSLs provide education to KOLs regarding the science behind the product and how to use it.
- Post-launch: MSLs answer clinical questions for prescribers and medical professionals and provide continuing education to KOLs.
MSLs offer unique insights into market access and engage with external contacts such as KOLs to give the product sales team information it can use to develop strategies that promote the brand.
How is the Role of the MSL Emerging in the Clinical Trial Process?
Clinical trials are the backbone of product development, and the MSL is a critical and positive emerging component in this process. The MSL can contribute in a number of key areas:
- Defining KOLs and site selection
- Providing disease state and therapeutic training
- Generating interest in the science behind new molecules
- Assisting with study design
- Identifying assessments that will add value as the product prepares to launch
- Examining the competitive landscape
- Providing insights on patient perspectives through experience and patient advocacy relationships
Primarily, the MSL serves as a scientific conduit between clinical trial project managers and external stakeholders. MSLs have the opportunity to spend substantial time with physicians and healthcare teams. Indeed, according to a survey by the MSL Society, KOLs are willing to spend 45 minutes with an MSL compared to just two minutes with a sales representative. This means that MSLs are in a unique position to provide pharmaceutical companies with important insights such as how practitioners use similar products (including competitor products) and ways to improve patient enrollment and retention. That knowledge is a potential resource in developing clinical trial strategies.
The MSL is a scientific peer for physicians and other healthcare providers who have ideas or concerns when running a trial. It’s the job of the MSL is to make connections with KOLs and create opportunities for clinical investigators. They are responsible for population analysis, too, when finding potential trial sites.
As well as key involvement in product development, MSLs have an increasing role to play in clinical trials, especially as drugs become more complex and targeted. They can engage across multiple aspects of the trial and offer clearer and more concise peer communication. And with their scientific and regulatory expertise, customer focus, and relationship building and management skills, it’s clear why MSLs are such an indispensable asset in clinical development.