To advance medical knowledge and test new methods of treatment for a variety of conditions, researchers often conduct clinical trials. Researchers use volunteers, also known as participants, to test programs or products that can help prevent or treat a medical condition.
What is a Clinical Trial?
Testing new medical treatments helps make sure that a program or product is safe and effective. People of different ages, racial or ethnic backgrounds, and health conditions may have a different reaction to a product or program than others. This is one of the reasons that diversity in clinical trial participation is so critical.
A clinical trial is often structured to measure the effects of treatment across a wide demographic, including participants that represent people of different ages, ethnicities, and health conditions. Researchers must ensure that they have the right number and mix of participant characteristics to get accurate, usable results.
Types of Clinical Trials
There are two general types of clinical trials: interventional studies and observational studies. Interventional studies involve introducing a product - like a drug or device - to a patient’s treatment regimen. Alternatively, they could be structured around a behavioral intervention - like diet or exercise - that is changed. In either case, the effects of the intervention are observed recorded to determine the efficacy of the treatment.
Observational studies, on the other hand, are based on recording data without making any changes to the participant’s treatment, procedures, or lifestyle. A sleep study, where researchers watch and record participant sleep habits, is an example of an observational studies.
Clinical trials may be focused on early detection of an illness or disease, prevention, or reducing the effects of chronic health issues. Sometimes, a clinical trial will focus on the support groups or caregivers that work with people suffering from an illness or health condition.
Why Participate in Clinical Trials?
Better healthcare for you
A clinical trial participant with an existing health condition can access new treatments before they are released to the general public. Treatments available through clinical trials may prove more useful or effective than those currently in use - and clinical trials may begin years in advance of when a treatment is approved for the general public.
Some people choose to participate in a clinical trial to take a more active role in their own health management. Others prefer to have more frequent health check-ins than a normal course of treatment provides. Whatever the reason, clinical trial participation can be a positive experience for many people.
Advance healthcare for others
Some studies are designed to test treatments on participants that do not have a specific healthcare condition. Perhaps you are looking to be helpful in finding an effective treatment for a disease or condition that has affected you or the people close to you. Or maybe you are interested in advancing medical science in a more general way. There are many clinical trials available that are looking for participants of all demographic groups.
Where Can You Find a Clinical Trial?
Traditionally, sponsors of clinical trials would have to get the word out through advertisements, connections with healthcare providers, and community liaisons. And while those avenues are still used, the increasing use of digital channels is making it easier than ever to participate in clinical trials.
For example, thousands of people interested in participating in clinical trials have signed up with Research & Me. On this platform, anyone can sign up to be a participant in a clinical trial and search for trials that meet their needs. Or if they choose, potential participants can sign up to be contacted by researchers when new trials become available. Research & Me makes the awareness stage - finding out about about clinical trial opportunities - easier than ever before!
What to Expect from a Clinical Trial
When you first become interested in a clinical trial, you may have questions regarding the length of the study, requirements for participation, and potential or expected side effects. Generally, you can find answers to these questions in the clinical trial description, or if not, you can contact the trial sponsors to get the information you need. Your experience may also be changed depending on what phase of study the clinical trial is in.
Phases of Clinical Trials
The U.S. Food & Drug Administration has created a phased system for clinical trials. After researchers have conducted extensive tests on a medical intervention using non-human subjects, they can be approved to begin Phase I - IV human trials. The initial tests are called pre-clinical (or laboratory) studies, and involve testing the performance of drugs, devices, and other interventions in lab-controlled conditions. For example, a cancer drug may be applied lab-grown cancer cells to see if it is effective at halting cancerous growth. Treatments that pass the lab-cell stage may then be tested on live tissue, then live animals. If the new treatments seems safe and effective on living creatures, the FDA may grant researchers the ability to conduct a clinical trial.
Phase I trials focus on safety. Generally, researchers test a treatment on a small group of participants (20-80), often healthy people, to make initial estimates as to the safety, side effects, and dosage of medicines on a regular population.
In Phase II, participant groups are larger, increasing in size to 100-300 participants. Phase II are generally small trials focusing on effectiveness - testing whether researchers actually achieve the expected results. However, in Phase II safety is still a major concerns, as researchers continue to track and study the safety and side effects of the treatment on a larger population.
Depending on the results, a Phase II trial can last for several years before the trial is moved forward to Phase III.
Phase III continues the study of safety and effectiveness, but expands the population of the study, with participant numbers ranging from several hundred up to 3,000 people. In Phase III, there is also a deeper investigation into dosage variations, and combinations of treatment with other changes, including devices or drugs.
If the trial results are positive, the FDA may then allow the treatment as a Phase IV experimentally-approved treatment.
Phase IV follows FDA approval for use, when a drug can be obtained through a healthcare provider. Just because a drug is released for use doesn’t mean that research stops - the effectiveness and safety continue to be monitored, just in larger and more diverse populations. Phase IV allows data to be monitored in the largest potential user group, usually over a longer period of time than Phases I-III.
If you, or someone you know is interested in becoming a clinical trial participant, or learning more about how participation can help advance medical treatments, check out the Research & Me participants page today!