Protocol Planning And Design For Quality Decentralized Clinical Trials

Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?

When designing a trial there are three fundamental questions that must be asked for every study.

• What is the purpose and research question of the study (e.g., to show the treatment is safe or efficacious)?
• What data are needed to answer the research question?
• How will the data be captured?