Clinical Trials

❘❙❚■ Chapter 3 | Protocol DevelopmentTrial summary or synopsisA synopsis should provide the key aspects of the protocol in no more than twopages, and can be prepared in a table format. The main components of theprotocol summary include:• full title• principal investigator• planned study dates• objectives• study design• study population• treatments• procedures• sample size• outcome measures• statistical methodsFlow chartA flow chart is a schematic diagram that summarizes trial design, procedures,and stages. It emphasizes the timing of enrolment procedures, study visits, studyinterventions, and follow-up assessments.Background and rationale of the trialThe background section is built on experience gained from previous research.It describes the test treatment, including an outline of what is known about theeffects of the treatment from previous research, and gives a rationale for thecurrent research study. The main aim of the study background is to give the readerthe knowledge they require to understand the questions or hypothesis of the study.A systematic review of the study topic should be performed beforehand. This is aneffective way to summarize the relevant available data. The basic structure of thebackground section should include (in this order):1. known research on the topic2. what is unknown about the topic3. the study question or hypothesisIn clinical trials that involve an IMP, various aspects of the treatment and thedisease should be elaborated on. These include existing epidemiological dataregarding the disease (along with references to the literature), possible existingcaveats in available therapies, and potential benefits that can be achieved throughthis trial.28