The Phases of Clinical Trials
Every year, millions of people die due to chronic medical conditions. In the United States alone, 37 million or 1 in 7 American adults are suffering from chronic kidney disease (CKD). Chronic kidney disease, like many chronic illnesses, can potentially be fatal if not immediately treated.
Aside from what’s already available, researchers continue to find new treatment options for patients with CKD. New treatments and forms of therapy are possible because of research from clinical trials. Before these treatments get the green light, they go through trials to assess effectiveness and safety.
Why clinical trials are important
Clinical trials help researchers test the efficiency of treatment. They also help establish any side effects, risks, and other factors that could affect patients.
These trials are essential because they allow researchers to see exactly what does and doesn’t work. This knowledge helps ensure that treatment modalities are safe and efficient before they are accessible to the public.
The phases of clinical trials
Clinical trials go through four important phases with each phase having a different goal:
Phase 1
- This step aims to ensure the safety of treatment to humans and how it works within the body. Researchers test a small group of healthy volunteers to note any serious adverse effects and side effects that could put patients in danger.
In some cases, clinically available drugs are “re-purposed” for another disease. Since these drugs already underwent Phase 1, they can move on to Phase 2 faster.
Phase 2
- This step tests the right dosage and efficiency of a drug in treating a specific medical condition. Here, researchers will test a large group of volunteers suffering from that disease to see if they show any improvements.
There will also be a “control group” who will receive the current treatment available or a placebo treatment. This will help researchers make comparisons to understand the efficiency of treatment better.
Phase 3
- This step focuses on determining if a treatment is safe and effective for use in a wider demographic. Here, researchers use a bigger group of volunteers. A portion of these volunteers receive the drug and the rest will be under the control group.
Phase 4
- This step happens after the FDA approves the drug and it goes through Post-Market Surveillance. The purpose of Post-Market Surveillance is to see how the treatment works when administered to real patients. This ensures that there are no side effects or adverse effects that could put the public at risk if the treatment continues to be released into the market.
Why clinical trials are essential to NICR
NICR has always been committed to ensuring patients with chronic kidney disease are able to live the best quality of life possible. Clinical trials allow us to get an in-depth look at the disease process and learn more about the efficiency of the different treatment options that we’ve developed.
NICR puts a lot of emphasis on the importance of clinical trials as part of our system and we continue to strive to offer the best treatments to patients with chronic kidney disease, so they can live longer and healthier lives.
The National Institute of Clinical Research is an SMO/CRO with offices and labs in the following cities and states: New Jersey, North Carolina, Austin, San Diego, San Francisco, Bakersfield 93309, Fountain Valley 92708, Garden Grove 92840, Hacienda Heights 91745, Huntington Beach 92648, Las Vegas 89106, Long Beach 90806, Los Angeles 90048, Ontario 91762, Rosemead 91770, San Antonio 78207, Santa Ana 92704, Upland 91786, and Westminster 92683.
