Pharmaceutical Medical Affairs And The Role Of Real-World Evidence | PurpleLab®

This blog is part four in a series exploring the use of real-world evidence to produce meaningful insights in clinical pharma. 

Medical affairs is a department within pharmaceutical companies that focuses on communicating scientific and clinical information to healthcare providers. Pharmaceutical medical affairs teams are responsible for activities that bridge the gap between the development and commercialization of drugs. Staffed by individuals with advanced degrees such as MDs or PharmDs, medical affairs teams engage with providers and other stakeholders to educate them around correct usage of the drug as well as answer their queries around safety, off-label usage, scientific publications, and more.

How do pharmaceutical medical affairs teams support the drug development process?

Medical affairs are crucial in healthcare for translating complex and ever-evolving information into accessible knowledge for healthcare providers. In this regard, these teams facilitate the introduction of drugs to the market, educating providers around their benefits and ultimately improving patient care.

Medical affairs teams are responsible for providing up-to-date medical information to internal teams, healthcare professionals and patients about the drug and its clinical data. In addition, they help train sales and marketing teams on the scientific aspects of the drug to ensure accurate and compliant messaging.

Furthermore, they monitor the drug’s safety through post-marketing pharmacovigilance as well as liaise with key opinion leaders, patient advocacy groups and professional societies to gather insights and feedback.

How do pharmaceutical medical affairs teams use real world evidence?

Medical affairs teams play a crucial role in managing a pharmaceutical company’s scientific and clinical data, which influences everything from sales and marketing to portfolio planning. The more extensive and varied the data they analyze, the richer the medical insights. For this reason, real-world evidence (RWE) is a game-changer for medical affairs teams, as it provides valuable insights beyond clinical trials to inform various aspects of their work — from brand and marketing strategy to educational initiatives and more. RWE is derived from various sources, including electronic health records, claims data, patient registries, and more. Here’s how medical affairs teams leverage RWE:

1. Generating Scientific Evidence to Support Product Value:

• Supplementing Clinical Trial Data: RWE, such as identifying clinical practice trends, can complement findings from clinical trials by providing a broader picture of a drug’s effectiveness and safety in real-world clinical practice. This can be particularly useful for understanding how a drug performs in different patient populations or identifying rare side effects not captured in trials.
• Identifying Unmet Medical Needs: RWE can help medical affairs teams understand disease burden, treatment patterns, and patient outcomes in real-world settings. This aids in identifying areas where existing treatments fall short and informs strategies for developing new drugs that address unmet medical needs.
• Informing conversations Key Opinion Leaders and Patient Advocates: Armed with RWE data, medical affairs teams can enter into conversations with KOLs and patients advocates in an informed manner, and can more readily address any queries they have.

2. Medical Education and Communication Strategies:

• Developing Educational Content for Healthcare Professionals: RWE can be used to create targeted educational materials for healthcare providers (HCPs) that address real-world challenges and considerations when using the drug. This can include insights on patient selection, potential drug interactions, and managing side effects in a real-world context.
• Supporting Value-Based Communication: RWE helps medical affairs teams demonstrate the value proposition of a drug to HCPs and payers (health insurance companies) by providing evidence on real-world outcomes and cost-effectiveness compared to alternative treatments.
• Enhancing Scientific Publications: By incorporating RWE into scientific publications, medical affairs teams can provide a more comprehensive view of a drug’s impact. 

3. Post-Marketing Surveillance and Pharmacovigilance:

• Proactive Safety Monitoring: RWE allows medical affairs teams to continuously monitor the safety profile of their drugs after launch. By analyzing large datasets of real-world data, they can potentially identify rare safety signals or adverse events that might not be readily apparent in controlled trials.
• Understanding Off-Label Use: RWE can reveal how physicians are prescribing medications outside their approved labels. This information can inform future research efforts and potentially lead to pursuing label expansions for the drug.

Overall, RWE empowers medical affairs teams by enhancing the credibility of their products among healthcare professionals and payers. By leveraging robust data from real-world settings, medical affairs teams can present compelling evidence that supports the efficacy and safety of their company’s drugs. This in turn fosters greater trust and acceptance from the medical community. 

Additionally, RWE aids in the development of targeted medical education and communication strategies, allowing medical affairs teams to address specific needs and concerns of healthcare providers and patients effectively. It also enables proactive monitoring of drug safety, facilitating early detection of potential issues and identifying areas that require further research. Furthermore, RWE helps medical affairs teams to demonstrate the real-world value proposition of their drugs, providing concrete evidence of their benefits and effectiveness in everyday clinical practice.

However, it’s important to remember that RWE comes with certain limitations that must be taken into consideration:

• Data Quality: RWD (real-world data) may have inconsistencies and biases due to how data is collected in routine clinical practice. Medical affairs teams therefore need to carefully assess data quality before using it.
• Observational vs. Interventional: RWE studies are observational, meaning they don’t establish cause-and-effect relationships as definitively as randomized controlled trials. 

Despite these limitations, when effectively leveraged, RWE can empower medical affairs teams to ensure the optimal use and value of their company’s drugs in the real world.