Clinical trials consume a significant portion of the pharmaceutical industry’s research budget at approximately $78billion/year. Yet 80% of these clinical trials are delayed or closed due to issues with recruitment, with 37% of sites under-enrolling volunteers and 11% failing to enroll even one patient.1 The problem is staggering in terms of absolute financial and human costs. Enter the Clinical Trial Medical Science Liaison (CTMSL). This specialized scientific role can do much to address these recruitment and retention challenges pharmaceutical companies often face when running clinical trials.
In essence, the CTMSL brings the relationship-building and scientific expertise of the traditional MSL into the R&D space, complementing traditional MSLs by bridging the gap between trial sites and pharma organizations, work which is typically beyond the scope of those focused on marketed products.
Pharmaceutical companies can effectively leverage CTMSLs in several key clinical trial areas to improve their overall results:
- Site management/support. The CTMSL will regularly visit clinical trial sites and provide ongoing support with or without the current CRO. They work to make sure that the sites are working within compliance and adhering to good clinical practice guidelines, addressing any concerns with study protocol and/or regulatory issues and reporting their findings to the sponsor.
- Patient recruitment. CTMSLs can play a key role in patient recruitment by making sure that the CRAs are well educated on the importance of the clinical trial and behave accordingly. When the clinical trial requires enrollment for underserved populations, this education would address the cultural and social challenges one must overcome in enrolling these populations. In addition, CTMSLs can target appropriate HCPs within a reasonable geographic proximity to the clinical trial sites in order to raise awareness and educate on the trial protocols to encourage referrals of patients who might benefit from the trial.
- Training and education. In recent years, the skill sets within the CRO and CRAs have evolved, with fewer CRAs having a deep understanding of the healthcare environment and its complexities. This shift has posed challenges for the industry, contributing to recruitment and retention difficulties. The CTMSL can help address these challenges by collaborating with sites to provide training, education, and timely updates on clinical developments, fostering stronger, more productive relationships.
- Troubleshooting challenges. One of the tasks of all MSLs is to communicate insights from the field back to the pharmaceutical organization. In clinical trials, this is a crucial component of the remit. CTMSLs can be asked to problem solve clinical, procedural or ethical issues that arise at these sites. In so doing, they are charged with communicating any insights gleaned from addressing these concerns with the pharma company in a timely manner. This will ensure that all challenges are addressed as soon as possible, and the trial continues without delay.
Best Practices for Optimizing CTMLs
To optimize CTMSL impact, pharmaceutical organizations should first establish a “ways of working” document for in-person, written, or conference call communication. This document should establish the points of contact that will ensure transparency and meet the needs of all stakeholders, avoiding redundancy for optimum efficiency. The CTMSL remit and key performance indicators (KPIs) should be clearly defined, and distinct boundaries from their MSL counterparts established. CTMSLs should also be directed to share communication logs, training materials and activity visit reports with internal stakeholders on a regular basis to keep all parties abreast of what is occurring in the field.
The timely delivery of actionable insights is critical to the effective management of a clinical trial. Therefore, the CTMSL should be trained on what comprises a good, succinct, actionable insight and its inherent urgency so that the pharmaceutical company understands the value of the insight and the need for an immediate change. Not only do these insights make for good communications with internal stakeholders in terms of actions needed, they also demonstrate the overall value the CTMSL team brings to the organization.
The future value of CTMSLs
The CTMSL concept has redefined the potential of an MSL team, creating a new path for Medical Affairs to make a broader impact. This impact will only continue to strengthen as Medical Affairs brings technology and AI within its clinical trial support, communication methodologies, relationship building, mapping and data analytics. The utilization of current databases and AI technology by CTMSLs to harvest data analytics for actionable insights on identifying viable, new clinical trial sites is one such example.
Leveraging a network of scientists and incorporating them during clinical trials offers significant advantage to the pharma industry. How the CTMSL role evolves, and how the CTMSL taps technology, will vary by company. However, by implementing CTMSLs early in the clinical trial process, the industry is establishing highly valuable, key relationships within a network of HCPS upon which they can draw throughout future commercialization efforts.
1 Antidote: “What clinical trial statistics tell us about the state of research today,” https://www.antidote.me/blog/what-clinical-trial-statistics-tell-us-about-the-state-of-research-today, accessed October 1, 2024.
About the authors:
Jeffery Vaughan, PharmD
Jeff, a seasoned professional with 17+ years in healthcare and pharmaceuticals, leads Medical Affairs at Inizio Engage, focusing on Medical Science Liaisons. With over 15 years in field and director-level MSL roles, he supports initiatives in Immunology, Infectious Disease, Vaccines, and more. Jeff’s expertise has led to authoring articles and podcasts, solidifying his status as an influential thought leader in the industry.
Tiffanie Stewart, PhD
Tiffanie, with nearly 12 years in clinical research and medical affairs, excels in simplifying complex healthcare issues with data-driven solutions. Her expertise spans various therapeutic areas and industries, including FDA-regulated drugs and laboratory-developed tests. Leading MSL and Medical Affairs teams, she pioneers innovative solutions for enhanced MSL excellence at Inizio Engage.
Brenda Lemus, MD
Brenda, with 20 years of experience in a variety of medical affairs positions along with roles in academia and clinical research, currently serves as Director of a Clinical Trial Liaison Team. She is a passionate leader, highly skilled in hiring, leading and coaching MSL teams as well as developing and implementing comprehensive training curricula for continuous improvement and working to address health equity in clinical trials.
Have an opinion on this article? Send a message to the editor.