The role of the medical affairs (MA) professional is constantly evolving, thanks to ever-increasing advancements and broadening scope of work in the pharmaceutical and healthcare domain. Of late, MA professionals are seen to increasingly get involved in the drug development process in order to manage market access and reimbursement challenges while also facilitating drug discovery, pre-clinical and clinical research. The function of MA professionals can undoubtedly be incorporated into the entire drug development and commercialization process right from the stage of proof of concept till the end of the product life-cycle.(1)
Clinical research organizations (CROs) usually manage clinical trials from phases I through IV. In case of investigator-initiated trials (IITs), the study is conducted with the help of the MA teams with the necessary expertise to improve the quality and consistency of the collected data. This is not only because of the nature of business of the MA professionals, but also because of their expertise in the clinical research domain, whereby they are in a position to easily understand the reasons for the success and failure of a clinical trial. MA teams are also expected to be capable of identifying the reasons for a methodological flaw in a study design and act upon it sooner to rectify the situation. The lengthy product life-cycle necessitates the expertise of MA personnel in studies aimed at reviving the life-cycle of an existing commercialized drug.(1)
Tools like the Investigators Satisfaction Index are increasingly being used to identify important issues investigators face regularly; for e.g. understanding the complexities of study protocols. These issues are a result of intricate therapy regimes and the refined guidelines for the treatment of most clinical conditions, resulting in narrow patient populations as another aspect adding to the already complex study design. Consequently, it is also often harder to recruit new patients, which often leads to premature study termination. The demanding nature of modern clinical studies has led to the emergence of a new role within MA – the Investigator Science Liaisons (ISLs). There are several major differences between ISLs and Medical Science Liaisons (MSLs). ISLs interact with the investigators at a much earlier stage than MSLs, which could be as early as phase 2 for the ISLs to assist the investigator. By contrast, MSLs generally come into the picture after the data from phase 3 studies is obtained. During a clinical study, ISLs work closer with the investigators than MSLs and look out for any challenges investigators face. The troubleshooting capability of ISLs enables the sponsor (pharmaceutical company or a CRO) to design a plan to help investigators and eventually improve patient recruitment.(2)
Furthermore, ISLs ensure that the investigators are well acquainted with the study objectives and the protocol. They communicate between study monitors and investigators to improve problem-solving. After study completion, the RWE brought in by the ISLs can prove vital to facilitate the development of new protocols for future studies. ISLs also help maintain strong relationships with the investigators who are leading subject experts, thus furthering later stages of drug development.(2)
Moving forward, many changes will be witnessed in MA function, the pathways of clinical development, the product life cycles, and the relationship between MA working with internal and external stakeholders, like CROs. The science of clinical research will continue to change with constant data integration/visualization, personalized medicine, and mobile technology.(1)
- Beelke ME. The Evolving Role of Medical Affairs: Opportunities for Discovery, Preclinical and Clinical Research. Journal for Clinical Studies 2017; 9(3):20-24.
- Denisova N. How Medical Affairs might help in patient recruitment for Clinical Trials: a closer look at the new role of an Investigator Science Liaison. September 2019. Available at: https://www.linkedin.com/pulse/how-medical-affairs-might-help-patient-recruitment-trials-denisova