How to Conduct a Clinical Trial: Overview

This chapter lays the groundwork for understanding the science of clinical trials. It is a primer on conceptualizing and operationalizing a clinical trial in dentistry. Subsequent chapters will address specific clinical areas and highlight methodological issues that are of particular importance to that discipline. In this chapter, we discuss critical initial steps in planning a clinical trial: developing a theoretical model of the problem, establishing specific objectives and hypotheses, articulating a theoretical model of the intervention, and establishing a scientific rationale for the study. After initial planning steps are achieved, there come the steps involved in protocolizing and financing the intervention: assembling an interdisciplinary team, establishing a study timeline, gathering an advisory group, choosing sites, budgeting and financing, obtaining study funding, obtaining clinical trial insurance, getting IRB (ethics) approval, addressing FDA and other regulatory issues, and registering the trial. Next comes preparatory work prior to the trial that involves staff training and certification including calibration and fidelity and establishing a study flow chart. The last steps are finalizing the trial design elements which include: allocation ratio, participant characteristics, recruitment protocols, intervention details, outcomes, advanced data collection considerations, sample size, randomization, blinding, statistical methods, data security, harms, limitations, generalizability, and publishing the protocol. Thinking about these steps far in advance will help you and your team iron out study details that are important in helping to answer your clinical questions and hopefully generate scientific evidence that can help to solve your clinical problem.