Administration of Study Treatments and Participant Follow-Up

Abstract

After clinical trial participants have consented, provided baseline data, and been randomized, each participant begins study treatment and follow-up. This chapter covers administering a participant’s randomly assigned treatment regimen and collecting the participant’s trial data through the end of their time in the study, along with tracking and reporting data on timeliness and quality of treatment administration and of follow-up visit attendance and trial data collection. Treatment administration can include providing study medications or, in a lifestyle intervention trial, teaching the participant to follow a diet, exercise, or smoking cessation intervention. Trial data collection includes, for example, questionnaires completed via smartphone, laboratory sample collection details and results of lab analyses, imaging data, treatment adherence data, measurements taken at clinic visits, and adverse event data. Monitoring participant follow-up and capturing reasons why patients discontinue treatment or end follow-up early can aid in interpretation of a trial’s results. Treatment administration, treatment adherence, and participant follow-up metrics should be captured in real time, with the Data Coordinating Center (DCC) providing continuous performance feedback to study leadership and to the participating sites themselves. These aspects of trial conduct are described in the context of a multicenter trial in which two or more clinical sites enroll participants and study data are managed in a centrally administered database. Timeliness and accuracy of study treatment administration is key to the success of a trial. Participants providing required data according to the protocol-defined schedule allow a trial to attain its goals.