The Digital Era is Expanding the Scope and Impact for Medical Affairs

Julia Lakeland

The digital era-continues to transform the pharmaceutical and biotech industries, from how data is gathered and analyzed for R&D and clinical trials, to the development of highly personalized genomic treatments, to post-market pharmacovigilance.

The rise of ubiquitous digital technology also is elevating and expanding the role of medical affairs, which is poised to become the fourth strategic pillar of life sciences organizations, alongside R&D and commercial and market access.

McKinsey & Company documents the importance of this evolution in its report, A Vision for Medical Affairs in 2025, writing, “With their medical credentials, scientific know-how, and credibility among stakeholders, medical affairs professionals are emerging as the natural ‘owners’ of scientific knowledge and data within the organization and across the lifecycle.”

The Medical Affairs Professional Society (MAPS), attuned to these developments and what they mean for the profession, recently released its Vision for Medical Affairs for 2030:

“Medical affairs will be a strategic leader at the center of clinical development and commercialization efforts, identifying and addressing unmet patient, payer, policymaker, and provider needs that advance clinical practice and improve patient outcomes.”

The 2030 vision identifies several focus areas of growing importance for medical affairs, including data dissemination/communication, external relationships, strategic insights, evidence generation, and patient engagement.

Success in each of these areas hinges on the ability to capture real-time data from a growing number of sources, including directly from patients themselves.

Medical affairs runs on data

Medical affairs serves as the vital bridge between the pharmaceutical company and clinicians and patients. Medical affairs professionals communicate scientific and medical information to various stakeholders, ensuring that patient safety is never compromised, and the efficacy and effectiveness of the drug is measured in accordance with proven scientific and research outcomes

Medical affairs is in a unique position to gather and interpret wider therapeutic context through the use and inclusion of rich datasets derived from real-world evidence (RWE), electronic medical records (EMRs), wearables, and ePRO/eCOA platforms. These technologies provide an opportunity to calculate data-driven decisions that can optimize the study design journey and improve patient outcomes.

Coordination, planning, and proactive analysis are critical to optimizing the design of clinical studies to support desired study endpoints and outcomes. As a best practice, statistical data plans for analysis should be designed and agreed upon early in the study build process when systems are still being implemented. This approach streamlines data mapping for analysis at key study milestones and ensures fragmented data sources can easily be linked as appropriate.

Patient engagement stewardship

Strong patient engagement is fundamental to clinical trial success, from recruitment through data lock. Higher levels of engagement lead to greater compliance and retention; more accurate data to determine therapeutic efficacy and ensure patient safety; and faster, more cost-effective, time-to-market. In addition, best-in-class medical engagement generates valuable data on outcomes and cost of care for specific populations in real-world settings.

The MAPS Vision 2030 highlights the unique role that medical affairs plays in patient engagement and how it must expand and evolve in the near future:

“Medical affairs must own the scientific aspects of ‘patient’ engagement. This will require medical affairs organizations to transform patient engagement from a somewhat unidirectional approach, with a team assigned to inform patient communities of the organization’s actions and progress, to a model in which patients and patient communities work as essential partners with industry throughout the life cycle.”

Digital technology is essential to this mission. Increased global penetration of smartphones and available internet connectivity are key drivers to adoption of mobile health technologies in the life science sector. To generate the highest possible rates of protocol compliance and data capture requires consumer-grade interfaces that offer engaging and personalized experiences which encourage and optimize participant engagement from recruitment to trial completion, and even beyond.

From unidirectional to bi-directional engagement

To achieve the patient-engagement paradigm shift, medical affairs needs to embrace new strategies and technologies, including:

• Focus on the entire journey map for a patient group and tailor communication strategies based on analysis of insights captured
• Embrace a test, learn, adapt approach to study design
• Engage directly with patients through apps and real-life interactions that are applicable to the patient need (For example, transgender young males with HIV have very different life approaches and social interactions than middle-aged patients with rheumatoid arthritis.)

Modes of engagement should be continuously refined by the medical experts through analysis of different data sources to drive study design refinement and more effective educational and marketing materials for patients.

Study sponsors need technology that gives them the flexibility to quickly respond to changing landscapes and offer highly personalized experiences to participants to maximize engagement. This requirement can be challenging to address in a heavily regulated market. However, by implementing and tracking basic platform, product, and user analytics that align to the participant journey—from recruitment to study conduct and completion—technology providers can help sponsors and CROs optimize the study design by identifying and visualizing which engagement strategies are most effective across sites, countries, and patient population groups.

eCOA/ePRO platforms and analytics

Advanced applications that encompass data analytics including eCOA/ePRO platforms can offer powerful new opportunities to improve patient engagement. Medical affairs is ideally positioned to receive and review the impact of the data captured from these sources so they can make more informed and timely recommendations about study protocol designs and other factors that impact patient treatment and safety.

eCOA/ePRO data and platforms are emerging as essential tools for medical affairs professionals as their roles change and expand. The key is that the platforms must be easy to use and put patients at the center of clinical, post-marketing, and real-world research.

They must meet patients where they are—physically, emotionally, cognitively, and technologically—and deliver the analytical capabilities that medical affairs professionals need to identify trends to support adaptive trials, elevate patient safety, and improve patient outcomes. Further, the platforms must be able to integrate with current and future external data sources, including wearable devices, social media, GPS, and public health databases to name just a few, for more granular and complete analysis of all factors.

Future medical affairs strategy

Medical affairs has a critical and growing role to play as the vital bridge between patient and pharmaceutical companies that helps to ensure patient safety and improve outcomes. Today, medical affairs professionals are responsible for building the voice of the patient into their organizations—which is no minor undertaking.

At the same time, digital technology will empower medical affairs to rise to this challenge. Increasingly apps and digital health technologies, including wearables and eCOA/ePRO platforms, will deliver more timely and granular insight to medical affairs professionals as they seek to inform and adapt protocols.

Further, these same technologies support and empower patients to play a more active role in clinical research and self-care. They are on track to enable efficacy beyond treatment with drugs alone, maximize interactions between the patient and physician, and improve overall data captured to support optimal treatment plans and outcomes. This is a winning proposition for patients, medical affairs, technology partners, and pharmaceutical organizations alike.

Julia Lakeland, chief product officer, uMotif