The history of clinical trials dating all the way back to 500 BC, the ideas behind clinical research and clinical trials have been evolving for quite some time. However, there still seems to be an air of mystery regarding clinical trials’ actual purpose and process.
Simply put, the purpose of clinical trials is to test the safety and effectiveness of an investigational drug or therapy. Clinical trials exist in phases. Human testing begins during phase 1, with a small number of healthy volunteers. In phases 2 and 3, more testing takes place to study the short-term and long-term effects of the investigational treatment. By phase 4, the drug or therapy has been officially approved by the US Food and Drug Administration (FDA) and will continue to undergo research even as it’s publicly available.
Breaking down the clinical trial process from a patient point of view can aid in simplifying the clinical trial process for future participants and can open doors for further research to take place. If you’re considering taking part in clinical research, here is a basic overview of the process of joining a trial at any phase.
Step #1: Do your research.
In most cases, clinical trials are looking to recruit people who are living with the condition that the specific drug or therapy being evaluated is targeting. For example, if you have type 2 diabetes, you may be eligible to participate in a clinical trial for a drug that could help ease diabetes symptoms.
During clinical trials, there is no promise that the drug will cure your disease or improve your quality of life. Prior to participation, talk to your doctor and any friends who have participated in a trial, do your own research, and be sure to ask questions.
Step #2: Participate in prescreening.
Before you can participate in a trial, you are required to fill out a prescreening form or questionnaire. This determines whether you (the volunteer) and the study are a good match for one another.
A prescreening form can ask questions regarding your general health, willingness and capability to attend trial visits, and anything else that may determine your eligibility.
Step #3: Sign an informed consent form.
If you are contacted after prescreening, this means you are eligible to participate in the clinical trial. The next step is to sign an informed consent form (ICF). This document breaks down participation details and the trial’s risks and benefits and also provides more information about the treatment being tested. An ICF is required prior to participation in any trial to allow you to make an informed decision based on your health and well-being.
Step #4: Screening.
After signing an ICF, trial-related procedures can now take place. Information is collected and procedures are conducted to further determine your eligibility. These procedures vary from study to study, but many include a physical exam, lab testing, a review of your medical history, and vital sign measurements.
Step #5: Trial group assignment.
If eligible, you’ll next be randomly assigned to either the treatment group (where you’ll be given the investigational treatment) or the control group (where you’ll receive the existing standard-of-care treatment or a placebo). Some trials are set up so that neither medical teams nor participants know who is receiving which treatment. This practice, known as “blinding,” helps reduce bias when reviewing the results of the study.
Clinical trials are available worldwide and can be accessed online or by talking with your doctor. If you or someone you know is interested in participating in a clinical trial, visit clinicaltrials.gov for more information.