A clinical trial is a required step in evaluating new medical treatments and interventions. It helps researchers determine the safety and effectiveness of potential medical products before they are made available to the public. There are several phases of clinical trials, each with a slightly different focus. Here at Cedar Health Research, we are presented with the opportunity to bring these clinical trials to our community and patients. Many of our Clinical Trials are in Phase 2-3 and initial testing has been done before being passed on to us. Every step of the clinical trial process is closely monitored, and patient care is overseen by at least one licensed physician and a full clinical staff. We are with you every step of the way from start to finish of your clinical trial journey.
Here’s a short overview of the Phases of Clinical Trials:
Phase 1:
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- Objective: This phase aims to assess the safety and tolerability of the investigational treatment in a small group of healthy volunteers or individuals with the target condition.
- Participants: Typically involves 20-100 participants.
- Focus: The focus is on determining the appropriate dosage range and identifying potential side effects.
Phase 2:
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- Objective: This phase expands the study to a larger group of individuals affected by the condition of interest to evaluate treatment effectiveness and further assess safety.
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- Participants: Involves several hundred participants.
- Focus: Researchers gather more data on the treatment’s efficacy and continue to monitor adverse reactions.
Phase 3:
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- Objective: This phase gathers more evidence on the treatment’s effectiveness, compares it to existing standard treatments, and detects rare side effects.
- Participants: Involves thousands of participants, often from diverse locations.
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- Focus: Data from this phase is crucial for regulatory approval decisions by health authorities.
Phase 4:
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- Objective: Also known as post-marketing surveillance, this phase occurs after the treatment is approved and available to the public.
- Participants: Involves a large population that receives treatment in real-world settings.
- Focus: Researchers continue to monitor the treatment’s safety and effectiveness in the long term.
Throughout all phases, the clinical trial process is tightly regulated to ensure participant safety and to safeguard the integrity of the data collected. Ethical considerations, informed consent, and rigorous study design are essential components of the clinical trial journey.
Our Recruitment and Patient Education Teams identifies and connects with eligible candidates for our current trials and then help to book an appointment with our On-Site Clinical Team. When you come in for your appointment, you will meet our well-trained clinical staff with decades of medical experience. You can feel comfortable asking our team any questions you may have when beginning your clinical trial journey. Many of these trials help individuals who have not been able to treat conditions with their primary physicians.
Clinical trials allow access to medication and treatments that are not yet available to the public. You are not just helping yourself, but also those around you by supporting new medical developments allowing treatments to be made public and help hundreds and thousands of other patients who are struggling with similar conditions. Our goal is to advance medical knowledge and provide patients with safer and more effective treatments. With your help, Cedar Health Research can do just that.
If you would like to see the active trials, we are offering at Cedar Health Research please visit our Trials Page
Resources:
U.S Food and Drug Development: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
National Institutes of Health: https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics