Introduction to clinical trials

After investigators test investigational new therapies or procedures in the laboratory and in animal studies those labeled as the most promising are moved into human clinical trials. Clinical trials are performed in human volunteers and preferable well controlled health care facilities to provide answers to scientific questions such as whether or not a specific treatment (drug, medical device, diagnostic) works does it work similar or better than other treatments? Is it safe or Does it have side effects?

Clinical trials are broken down into different phases(phase I, Phase II, Phase III, Phase IV for drugs; efficacy and safety for devices) aiming to gain information about the potential treatment effect, benefit its risks and how well may the investigational product works in real life conditions or in any other data aspect that helps to define or determine scientific research information.(e.g., cost-effectiveness or a treatment or general standard improves treatment effects) Trials are conducted according to a comprehensive plan or protocol. This document outlines the rationale, methods, types of human volunteers (healthy, patients) who can enter the trial schedule of tests and procedures, dosages administration, follow up or length of the study.

It also describes what to measure (endpoints) how to measure the endpoints type of information collected, how to analyze the data how to preserve the safety of the subjects while in the trial and how the research is or will be regulated by institutional or local authorities. The assumption of all this infrastructure is provide a legal safe framework to allow investigators and sponsors have a friendly environment to develop their research interests while subjects can make sure that their rights and benefits are fully protected.

We expect this course anticipate and provide a basic good understanding of the main aspects involved while conducting clinical research in humans.