Combination therapies are redefining how complex diseases are treated, but they also introduce a new level of scientific, regulatory, and documentation complexity. With multiple mechanisms of action, overlapping safety considerations, and evolving regulatory expectations, combination therapy trials demand exceptional clarity, precision, and consistency in clinical trial protocols.

As the volume of combination therapy studies continues to rise across oncology, immunology, and other complex indications, protocol quality has become a critical success factor. Poorly structured or unclear protocols can lead to misalignment across stakeholders, protocol amendments, delayed approvals, and increased risk to patients and data integrity.

This white paper offers an expert medical writing perspective on developing high-quality, regulatory-compliant protocols for combination therapy trials. Authored by Marta Mas, Executive Director of Medical Writing at TFS HealthScience, it draws on decades of experience translating complex scientific concepts into clear, actionable clinical documentation that supports efficient trial execution and regulatory review.

Inside, you’ll discover:

• How different types of combination therapies introduce unique protocol design and documentation challenges
• Best practices for structuring combination therapy protocols to improve clarity, consistency, and regulatory readiness
• The critical role of medical writers in aligning scientific intent, statistical design, and regulatory expectations
• Key considerations for risk–benefit analysis, informed consent, and safety monitoring in multi-intervention trials
• How emerging tools, including AI and digital technologies, are influencing the future of protocol development

Download the white paper to gain a medical writing–led perspective on navigating the regulatory and scientific complexities of combination therapy protocols, and learn how stronger documentation can set combination trials up for success.

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