Medical affairs is a critical function in the drug development and commercialization process. It ensures that scientific and medical information about a drug is accurate, balanced, and clearly communicated to healthcare providers, medical professionals, patients, and other stakeholders.

Statisticians work closely with Medical Affairs teams to help make the most of their data.

In this blog, we will introduce medical affairs, discuss the role of statisticians in supporting their teams, and share a case study illustrating our collaboration with a sponsor for a neurology drug.

Medical Affairs: A bridge between clinical research and the broader healthcare community

Medical affairs guide drug development strategy and clinical communication through different aspects:

Post-marketing studies

In the post-marketing phase of a drug’s lifecycle, Medical Affairs play a key role by supporting:

• Phase IV studies designed to gather additional information on a drug’s effectiveness and safety in the real-world setting.
• Observational studies aimed at understanding treatment patterns, patient outcomes, and disease epidemiology.
• Local affiliate studies driven by country teams to address specific market needs, regulatory requirements, or strategic priorities.

Exploratory analyses

Medical affairs teams perform exploratory analyses of clinical trials data to gather new insights in addition to those available at the time of the drug approval. These analyses could support:

• Label expansion, by extending efficacy or safety results to other populations.
• Scientific publications that help the activities in the medical and scientific community.
• Real-world relevance, by contextualizing trial results with clinical practice or patient needs.

Exploratory medical affairs analyses also help by exploring tertiary endpoints from completed clinical trials or by looking further at endpoints such as quality of life or biomarkers.

Analyses for publications

In addition to exploratory analyses, medical affairs conduct data analyses that are used to support:

• Medical education materials
• Congress abstracts, posters, and oral presentations
• Manuscripts

The role of the statistician in medical affairs

Statisticians (like those of Cytel’s Project-Based Services (PBS) team) work closely with medical affairs to support scientific and strategic objectives. Their role includes:

Deep understanding of the therapeutic context

Statisticians ensure analyses are relevant and aligned with clinical objectives by building a strong foundation of medical and scientific knowledge.

Support of medical affairs studies

Statisticians are hands-on, analyzing and interpreting medical affairs studies, helping generate real-world evidence and actionable insights.

Interdisciplinary collaboration
Working with clinical and medical writing teams ensures that outputs are robust and meet the latest standards in data communication.

Close collaboration with clients
Open communication helps align priorities, understand timelines, and ensure that deliverables support both scientific communication and business strategy.

Clear communication of statistical results
Statisticians translate complex analyses into accessible messages that can be shared with healthcare professionals and internal stakeholders.

Familiarity with regulatory submissions
Knowing the key findings from submission dossiers allows for continuity between regulatory and post-marketing activities.

Case Study: Supporting a neurology drug from submission to post-marketing

A pharmaceutical company conducting neurology studies needed support for the regulatory approval process and post-approval work. Cytel’s specialized team of statisticians first collaborated with the sponsor at the regulatory submission stage by:

• Supporting the regulatory submission package (e.g., developing the statistical analysis plans for individual study and integrated safety and efficacy analyses, providing input on the clinical study report (CSR), etc.
• Supporting the regulatory queries (e.g., conducting sensitivity checks, long-term safety and efficacy analyses, etc.

Key contributions

The team’s familiarity with the data, as well as their ability to quickly adapt to evolving project needs and meet tight deadlines, enabled them to help the sponsor transition seamlessly from the submission stage to the post-marketing stage. Here, key contributions included:

• Exploratory analyses of clinical data to support scientific discussions.
• Continuous data interpretation and communication, transforming complex results into clear, impactful messages for medical teams.
• Support of the medical communication team in the development of congress abstracts by ensuring that statistical results are clearly and accurately presented. This includes creating high-quality graphical displays (e.g., Sankey plot, Volcano plot) and many other standard and unusual visualizations that can be directly used in congress posters.
• Creation of slide decks for external use, tailored to different audiences such as steering committees or advisory boards. These presentations require visually engaging graphics and a clear, concise interpretation of results to effectively communicate key findings.

Building effective collaboration

This collaboration with the client was highly effective, built on a foundation of mutual trust, communication, and shared scientific ambition. It was based on the following principles:

• Flexibility
  We adapt quickly to evolving project needs, changing timelines, and emerging priorities.
• Rapid Turnaround
  Our teams, composed on statisticians and statistical programmers are structured to deliver high-quality outputs under tight deadlines, which is critical for time-sensitive materials like congress abstracts.
• Ongoing alignment with current data
  We adjust/re-run analyses as new data becomes available, helping Medical Affairs teams stay up to date with the latest evidence.
• Specialized teams
  Our statisticians and programmers are experienced in preparing data for scientific communication. They are not only familiar with a wide range of data presentations that are typically used in the medical literature, but can also bring in creative solutions on how to make complex results accessible and relevant for both scientific and non-specialist audiences, including graphical data displays.

• Regular meetings and flexible communication
  Cytel PBS and client statisticians and programmers working on the same drug hold regular (usually monthly) meetings to ensure alignment and efficient progress. They embrace flexible and dynamic communication methods, including quick ad hoc meetings or written messages. This collaborative approach fosters transparency, improves cross-functional communication, and supports timely delivery of project milestones.

Final takeaways

This unique partnership enables high-quality deliverables and meaningful scientific engagement. Successful collaboration with medical affairs teams is driven not only by technical excellence, but also by trust, deep commitment, and cross-functional synergy.

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