Methodology and Protocol Development

This chapter outlines the key considerations for incorporating decentralized elements into trial protocols, addressing areas such as remote procedures, flexible participation, and evidence generation. It also introduces the core clinical research and additional members that can be added to enhance the team’s capabilities in a DCT. The impact of decentralized elements on the trial team is discussed, emphasizing the importance of feasibility in addition to scientific rigor. The chapter also delves into the preparation considerations for ethics committees and investigational review boards, offering insights into addressing concerns and justifying DCT elements. A hypothetical full DCT is presented to illustrate the strategy and execution of a trial, focusing on trial objectives, endpoints, design, and participant criteria. The chapter concludes by emphasizing the critical skill sets required for success in innovative clinical trial design: a strong clinical background, technological understanding, and expertise in behavioral change management. Recognizing the need for change, having a vision for transformation, and understanding the processes involved is essential for creating meaningful and lasting improvements in clinical trial participation.