Clinical trials are designed to test the safety and effectiveness of medical interventions designed to prevent, minimize or alleviate certain symptoms and illnesses. They’re used to test whether a particular medical treatment, drug, or device can accomplish what it is claimed to do, and to evaluate any side effects or unanticipated issues. Clinical trials are aimed at a large variety of illnesses, but cancer, cardiovascular and circulatory diseases, infectious diseases, hormone replacement and digestive diseases are among the top areas in which scientists and medical doctors continuously seek to test new medical interventions.
Before a phase 3 clinical trial can begin, initial phases must determine that the intervention (medication, procedure, device) is essentially safe and practical for humans. Pre-clinical studies include cell and animal studies.
Early phase clinical trials must be approved by the U.S. Food and Drug Administration (FDA) before a clinical trial can begin. Then, the research team and research sponsor must be approved, and the clinical trial participants must provide informed consent. Once these steps are completed, Phase I can begin.
The team leading a clinical trial must provide information to each participant in the form of a document called “informed consent.” This document describes every aspect of the trial so that individuals who’d like to participate are fully aware and informed about all that they will be asked to do, when, and why. Prior to joining a clinical study, participants must know and understand the answers to the following questions:
Exactly what is the eligibility criteria for this study?
Clinical trials have four phases. The purpose of these phases is to determine an appropriate dosage, test a medical treatment or drug, and to search for side effects on test subjects. The FDA must approve Phases I, and II before Phase 3 trials can begin. Note: Some clinical trials also have a Phase 0. Phase 0 can help a research team determine whether the clinical trial should proceed. A very small group of participants are tested to determine whether the medical treatment, drug, or device will work on humans.
Being part of these “first in human” studies, you will be assisting researchers to investigate the safety of a medicine that is currently being investigated. You may be required to have clinical exams and lab work as well as report any problems or side effects you experience.
At a phase 2 clinical trial, the researchers begin determining effective dosages of the medicine being investigated. This phase also includes determining side effects and risk factors.
Phase 3 clinical trials consist of an even larger group of participants (sometimes from around the world). The participation you give will help researchers get a clearer picture of the medicine’s side effects and potential effectiveness.
Even after a medicine becomes approved for use, you can still be part of clinical trials and assist researchers. These “open-label studies” assist researchers with understanding risks and potential benefits over longer periods of time.