Authors: Gerald L. Klein, MD; Roger E. Morgan, MD; Johannes Wolff, MD; Freddy Byrth; Marion Stamp-Cole; Melissa Palmer, MD
bridging innovation and practical application
As treatment regimens for both surgical and medical interventions grow increasingly complex, there is heightened need for focused medical affairs efforts to deliver thorough training and guidance to healthcare providers. Innovations in therapy often come with intricate dosing algorithms, novel mechanisms of action, and sophisticated delivery systems, all of which require clear, accessible, and evidence-based communication from medical teams. Practical aspects such as patient selection, dosage, safety, and tolerability should be clearly and concisely defined. Most devices require a human factors validation study, particularly those intended for patient self-use or in high-stakes clinical environments.
RWE Growth and Alignment
There has been a significant increase in the number of real-world evidence-based studies and their significance in both medical affairs and in product development. For example, PubMedindexed real-world evidence (RWE) publications nearly tripled between 2016 - 2018, rising from 326 to over 930 studies.[1] To foster better communication around this evolving body of work, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have developed a standardized glossary of terms specific to real-world data (RWD) and RWE.[2] Adoption of these terms helps ensure consistent interpretation, improves stakeholder communication, and supports regulatory alignment when using RWE in product development and labeling strategies.
Post-Launch Insights that matter
Launching a new product is a tremendous undertaking and also presents a valuable opportunity to gather timely, real-world insights through what we refer to as post-launch data capture. There is generally increased interest and excitement about a new product and early adapters are keen to try this, so it is an ideal time to capture important medical affairs information.
This is the time to query patients, healthcare providers (HCPs) and pharmacists on the following:
How well is the product understood: This gauges the depth of knowledge and clarity around the product’s mechanism of action, indication, administration route and monitoring requirements. Misunderstandings may lead to suboptimal use or hesitancy in adoption and the feedback helps inform targeted educational intervention.
Is it appropriately prescribed and dosed: This evaluates whether prescribers are using the product in accordance with the approved label, real-world best practices, and any clinical guidelines. Dosing errors or off-label trends may indicate gaps in education or highlight the need for label refinement or further clinical clarification.
Product effectiveness: This assesses whether the clinical benefits observed in trials are being replicated in routine clinical practice. Factors such as adherence, comorbidities, and healthcare access may influence this and require RWE follow-up.
Perceived product value: Assess the economic and therapeutic value as perceived by both patients and HCPs. Are the benefits seen as commensurate with the cost, burden of use, or any associated monitoring requirements? This is critical for market access, payer discussions, and retention. ▪ Willingness for HCPs to prescribe the product: Investigating barriers that may hinder prescribing behavior (clinical, logistical, financial or psychological). Even highly efficacious products may struggle if providers lack confidence or clarity in how or when to use them.
Willingness for patients to use the product: Examining patient acceptance, particularly around tolerability, ease of use, and alignment with lifestyle may lead to the understanding of cultural, social, or health literacy factors that shape decision-making.
Additional side effects: Examining emerging safety signals or tolerability concerns that may not have been apparent in the controlled environment of clinical trials which may include mild but impactful events that affect adherence and satisfaction.
Additional benefits: Possibly identifying positive secondary outcomes or “halo” effects that weren’t the primary focus of trials but are meaningful to patients or providers. These may include improvements in energy, mood, or comorbidity control and can become valuable talking points in peer-to-peer education and lifecycle management.
References
Makady A, de Boer A, Hillege H, Klungel O, Goettsch W. What is real‑world data? A review of definitions based on literature and stakeholder interviews. Value Health. 2017;20(7):858‑865. doi:10.1016/j.jval.2017.03.008.
Rivera DR, Cutler TL, McShane L, et al. Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration–National Institutes of Health Collaboration. JAMA Netw Open. 2025;8(6):e2516674. doi:10.1001/jamanetworkopen.2025.16674.