With the COVID-19 pandemic, clinical trials are in the news quite a bit these days. Qualmedica Research is well positioned to bring a COVID-19 vaccine trial to Bowling Green soon. The FDA provides many useful resources for people interested in volunteering for a clinical trial. Trials are usually described by the phase of drug approval. Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. Once a drug candidate moves into human testing the approval process typically takes 6-12 years. If researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects. The goal of this process is to make certain the drug is both safe and effective. The FDA typically requires Phase I, II and III trials to determine if the drug, device, or vaccine can be approved for use.
According to the FDA:
- A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
- Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects.
- A Phase III trial gathers more information about safety and effectiveness, studying different populations, different dosages, and in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.
If the FDA agrees that the trial results are positive, it will approve the experimental drug or device. •A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations to better understand side effects that may not become clear until more people have taken it over a longer time.
Qualmedica Research does not usually participate in Phase 1 safety trials, but we do offer patients the chance to volunteer for Phase II, III, and IV trials. In addition to knowing the trial phase, it can be helpful to understand what type of study you are considering and how likely it is that you will receive an active drug. For example, a placebo-controlled study divides the patient volunteers into groups. Some patients receive the study drug while others receive a placebo. The patient, doctor and study team are blind to who receives the study drug. After the treatment period ends, many studies offer an open-label extension. All patients that elect to roll into the extension study receive the study drug. If you have ever taken a prescription or over-the-counter medication, you have experienced the impact of a clinical trial. Someone volunteered to participate in the trial process so that people needing medicines, devices or vaccines would be able to get them. Patient volunteers that suffer with disease often benefit from participating in a study. They receive routine medical care by a licensed and certified physician and close monitoring to evaluate their response to the medication.
Many people volunteer because it brings them closer to medical discoveries that improve quality of life for themselves and others. Patient volunteers receive a per-visit stipend for time and travel expenses, free medication for the duration of the study, and routine follow-up care. No insurance is needed to participate in a study and volunteers can withdraw from the study at any time. Most study volunteers report positive experiences. In their 2019 “Perceptions and Insights Study,” The Center for Information and Study on Clinical Research Participation (CISCRP) found that 96% of people who participated in a clinical trial would be willing to do it again and nine out of ten participants would recommend a clinical trial to their friends or family members. You can make a difference…find out if a clinical trial is right for you. We are currently enrolling or pre-screening volunteers in Bowling Green for:
- Pediatric Migraine Ages 6-17
- Adult Diabetes w/Cardiovascular Complaints Age 40+
- Irritable Bowel Syndrome with Constipation Ages 6-17
- ADHD in Children Ages 4-5
- Infant Vaccine Study for Pneumococcas Bacteria (pneumonia, meningitis, sepsis, and ear infections).