New ways to treat, detect, and prevent different diseases are discovered all the time. But those potential options aren’t just put out to the public with a Hail Mary and good luck. Whether it be a drug, device, or therapeutic approach, every intervention is taken through the clinical trial process. Why? Well, they help us determine the safety and effectiveness of them in humans. While it’s easier to understand why those affected are needed to participate, healthy volunteers play a vital role. Clinical trials need healthy volunteers, and we’re going to show you why.
Healthy Volunteers and Clinical Trials
A healthy volunteer is considered someone without any significant health issues and is in good overall health. Before a potential new therapy can be publicly marketed, it must go through the four phases of clinical trials, with a preclinical phase initially (also referred to as phase 0). Each stage is designed to gather specific information like safety, dosage, effectiveness, and adverse reactions. Healthy volunteers are typically needed in the early trial stages in minimal numbers. Their participation helps set a baseline to compare in the intervention and serves as the control against other patient groups. Once the baseline is established, appropriate dosing, safety, and tolerability can be implemented and measured.
- Phase 1– 20 to 100 healthy volunteers or patients with the condition.
- Purpose– Safety and dosage
- Phase 2– Several hundred volunteers with the condition.
- Purpose– Effectiveness and side effects.
- Phase 3– 300 to 3,000 volunteers with the condition.
- Purpose– Effectiveness and side effects.
- Phase 4– Several thousand volunteers with the condition.
- Purpose– Safety and effectiveness.
Healthy volunteers are also vital to other types of studies and evaluating if new ways to detect certain conditions are safe and effective. All ages, races, ethnicities, and genders are needed for all types of volunteers.
Healthy Volunteer Opportunities at CPMI
Here at Clinical Pharmacology of Miami, our passion is to advance medicine in a safe, well-controlled, precise environment for our volunteers and staff. Trials and their participants help us better understand diseases, which paves the way for improving care for the people affected by them. To learn more about our upcoming healthy volunteer studies, call (305) 817-2900, or visit our website.
References:
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1710-5
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
