The pharmaceutical industry has been evolving and changing along the years, as has the way in which clinical trials are planned and executed. Clinical Development went from a fully inhouse clinical trials handling model, where each company had its own team of clinical operations to execute those trials, to a completely outsourced model where none of the members of the team were part of the company which was behind the development of the molecule in question, to the current hybrid model with shared responsibilities between the owner company and the clinical research organization (CRO) which really manages the projects. If we also consider the changes to the functions of the people responsible for the management of the trials, both on the monitoring and follow up level as on the global project supervision and management level, we find new barriers and challenges for the development of a proper clinical research activity.
All this has led to the appearance of new roles to assist in the research inside the medical departments of the pharmaceutical and biotechnology companies – to strengthen and maintain good relationships with the Key Opinion Leaders (KOLs) involved in the trials and to support other roles with less involvement in this research or even functions far from the field. We are talking about roles such as Clinical Trial Liaison (CTL), Clinical Trial Educator (CTE), Clinical Educator (CE), and Medical Science Liaison (MSL).
The MSL role, which has been part of the change and evolution of the industry since its beginning in the late 60s, is experiencing a boom in both relevance and prominence within the medical departments. Where has this boom come from? It is mainly a result of the MSLs understanding of the business and priorities for both the medical department as well as for the global company, which enables them to contribute to and improve outcomes for both patients and health care providers, always from a scientific perspective.
Broadly speaking, we can say that the role of the MSL comprises 3 fundamental tasks: scientific engagement with KOLs, insight gathering, and evidence-generation. This third pillar includes the involvement of the MSL role in company sponsored studies, investigator-initiated trials (IITs), clinical audits, and HEOR studies. The MSL takes part in these from their beginning overseeing the identification of the best and most relevant health care professionals.
Although the site/investigator recommendation is not the only activity supported by the MSL, and using some data obtained from the MSL Hiring Practices Survey performed by The MSL Society in 2018, we can see that a high percentage of MSLs participate in activities related to the clinical research such as investigator led research and coordinating company sponsored trials.
Originally the functions and responsibilities of the MSL role were more focused on the late phases of the clinical research (phase III and beyond). However, the survey data also reflects that, step by step, the involvement of the MSL regarding the sponsored clinical trials and IITs has been changing, becoming more relevant and contributory to the organization in all phases of the research. In fact, more and more metrics for supporting clinical research are included to evaluate the performance of the MSLs.
The following two bar charts reflect the metrics currently used to measure this task and the ones that should be used. In both charts, the organization and managing of ITTs is mentioned.
Something remarkable also shown by this survey is that during the initial training phase of a newly hired MSL, around 25% of the training is related to clinical trial design.
Therefore, due to the deep knowledge that the MSL has about the observational methodology, the project management and local and international laws and procedures, the MSL is becoming a key figure for the experts to advise them on their studies.
Considering everything mentioned above, it is clear that the MSL is getting involved earlier in clinical research activities. As soon as the draft of the protocol is ready, the MSL is informed and can then actively participate in the site selection and in the feasibility process. Besides this, the MSL gives scientific support during the initiation visits, and throughout the lifetime of the study they can assist to solve problems and even help in the recruitment.
Consequently, it is crucial to create and maintain very close relationships between MSL and the CRA roles. Although the scope of both roles is quite different, the final objective is the same and both are the face of the company in the field. Relationships between them should be based on trust and on the value the MSL can add because of the relationships the MSL has with the KOLs.
From our point of view, to achieve a fruitful relationship, the most important thing is to have clearly defined roles and responsibilities between CRAs and MSLs. We propose the following Responsibility Model to minimize the risk of overlap between the positions:
The construction of this model has been carried out with consideration for the most relevant activities during the life of any clinical research project, together with the responsibilities of the two most involved field actors.
Using this model, we can avoid confusion regarding those roles and responsibilities. As such, it is very important that this model be clearly communicated to CRA, CRA Leads, MSLs, MSL Managers and key stakeholders (including investigators).
If a clear Responsibility Model is implemented and the complementary skills of MSLs (technical expertise, environmental awareness and scientific/professional relationship holders) and CRAs (operational, regulatory and project management experts) are commonly understood, then the mutual benefit of MSL/CRA interplay will become obvious to companies, investigators and, most importantly, to clinical trial patients.
Eva Díaz, MSc,
Eva has a biology degree and specializes in efficient management of clinical trials with expertise in diverse functions within research and development departments as well as in medical affairs in both pharma and biotech organizations. In her nearly twenty years of industry experience, Eva has served in management and project leads in oncology, cardiovascular and IVH programs. In her current role, she serves as a MSL at Amgen in biosimilars, inflammation and bone metabolism
Victor Sastre, MS, MSL-BC
Victor has experience in the pharmaceutical & biotech industry, Medical Affairs and R&D. He is currently a Senior MSL (Senior RML) in Amgen, with responsibility in Biosimilars. Victor has previous experience at Parke-Davis and Pfizer, as well as, experience in Bone Metabolism, Neuroscience and Inflammation.