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Clinical Study Protocols: The Pillars of Clinical Development

Welcome to the 2023 Medical Writing Supplement developed as a collaboration between Samedant Ltd and Trilogy Writing & Consulting and published as part of the Winter edition of International Clinical Trials (ICT).

In this edition, we focus on the importance of well-written clinical study protocols as pillars in the pharmaceutical industry’s search for efficiencies and reduced drug development time. Our aim is to raise awareness of the far-reaching impact that well-crafted protocols can have on study quality and drug development speed.

The opening article by Julia Forjanic Klapproth highlights the critical role of the clinical study protocol as the cornerstone of a clinical study, and the negative impact poorly written protocols can have on study outcomes. As study complexity increases year on year, Walther Seiler and Jeff Garwin explore the fundamental importance of harmonised standards and protocol templates in ensuring high-quality protocols. Natalie King, Daniela Nakagawa, Jonathan Mackinnon, and Lisa Chamberlain James provide insights into some of the emerging protocol challenges and how they can be overcome.