What Are Clinical Trials?
Scientists and medical doctors design clinical trials to test the safety and effectiveness of medical interventions for preventing, minimizing, or alleviating specific symptoms and illnesses. They use these trials to determine if a particular medical treatment, drug, or device can accomplish its claimed goals and to identify any side effects or unanticipated issues. The top areas of focus for clinical trials include:
- Cardiovascular and circulatory diseases
- Infectious diseases
- Hormone replacement
- Digestive diseases
Pros and Cons Of participating in Clinical Trials
- You may be helping advance medicine and save lives.
- You’d have access to excellent medical care and services from top doctors and scientists in the country.
- You’d be taking a hands-on role in your medical care.
- You’d be utilizing a free or low-cost treatment.
- You may have access well before the general population to a medical drug, treatment, or device that has fewer side effects and is more effective than your current or past treatment.
- Some clinical trials offer compensation for participation.
- You may receive the placebo in the control group of the clinical trial, meaning you wouldn’t be able to experience the drug’s beneficial effects. However, at some point in many studies, sponsors will often treat those in the placebo control group when and if the intervention proves to be effective.
- Due to side effects, you may require more medical care during and/or after the clinical trial.
- You may not respond to the experimental treatment.
- Every study is different.
The phases of clinical trials
Clinical trials have four phases. These phases aim to determine the appropriate dosage, test a medical treatment or drug, and 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. Researchers test a very small group of participants to determine whether a medical treatment, drug, or device will work on humans.
PHASE I: SAFETY IS THE TOP CONCERN
Participating in “first in human” studies is an opportunity to contribute to advancing medical research and development. As a participant, you will play a crucial role in helping researchers investigate the safety of new medications and treatments that are currently being studied. The results of these studies will help determine whether the medicine is safe to use and whether it can be effective in treating specific illnesses.
PHASE II: EFFECTIVENESS IS THE TOP CONCERN
In phase 2 clinical trial, the researchers determine effective dosages of the investigated medicine. This phase also includes determining side effects and risk factors.
PHASE III: EFFECTIVE OPTIONS ARE THE TOP CONCERNS
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.
PHASE IV: PUBLIC SAFETY IS THE TOP CONCERN
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 more extended periods of time.
If Phase III proves that the experimental trial was successful, the FDA will approve the medical drug, treatment, or device.
Understanding the Clinical Trial Process
Before a phase 3 clinical trial can begin, initial phases must determine that the intervention (medication, procedure, device) is safe and practical for humans. Pre-clinical studies include cell and animal studies.
Before a clinical trial can begin, the U.S. Food and Drug Administration (FDA) must approve early-phase clinical trials.
Before starting the trial, the research team and sponsor must obtain approval and the clinical trial participants must provide informed consent. After completing these steps, the team can begin Phase I of the trial.
What to expect when you participate in clinical trials
The clinical trial team must provide information to each participant in a document called “informed consent.”
This document fully describes every aspect of the trial, including what participants will be asked to do, when, and why.
Before joining a clinical study, participants must know and understand the answers to the following questions:
- Why is this study being conducted?
- How long will the study last?
- Precisely what are the eligibility criteria for this study?
- How many participants are needed to complete this study?
- What medical information will I need to provide as a participant?
- What will medical information be gathered to further the study?
- What will medical drug, treatment, and/or device be used during the study?
- What tests, procedures, and drug dosages will participants be subjected to?
*Participants must be fully aware of this important information, so there aren’t any surprises or misunderstandings once the clinical trial starts.
Understanding sponsors’ needs
QLMRC understands sponsors’ need to recruit a diverse audience of participants for many of their studies. To aid in that regard, we have cemented relationships with and made substantial forays into:
- Local Chambers of Commerce
- Local print, digital and over-the-air media
- Local business groups
- Local medical colleges
- Local non-profits
In addition, Quality of Life Research and Quality of Life Medical Center are sister companies that share the same location. We can draw from our base of more than 6,000 patients and a new recruiting database of more than 3,000 participants.