Clinical trials are research studies performed that aim to evaluate a medical, surgical, or behavioral intervention. They help researchers evaluate a new drug or medical device to determine if it is:
Clinical trials also test methods of early detection of diseases, prevention of health conditions, and may also look at ways to improve the quality of life for people living with a life-threatening disease or a chronic health condition. Clinical trials may also study the role of caregivers or support groups.
There are two main types of clinical research studies:
The idea for a clinical trial often starts in the laboratory. After researchers test new treatments or procedures in the lab, the most promising treatments are moved into clinical trials. As new treatments move through a series of steps called phases, more information is gained about the treatment, its risks, and its effectiveness.
Clinical trials are done in four phases to test a treatment or, in the case of a new drug, find the appropriate dosage, and look for side effects. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for clinical use and continue to monitor its effects.
The main goal is to see if the treatment is safe.
People in Phase I studies can be healthy or have a disease.
Once a treatment is safe, then a Phase II study is done to see if the treatment works.
Phase II studies usually have more participants than Phase I studies.
A Phase III study compares a new treatment with a current treatment to see which is safer and works better.
Phase III studies have a large number of participants, sometimes thousands.
After a Phase III study shows that a treatment works and is safe, then the Food and Drug Administration (FDA) reviews it for approval.
After FDA approval and the treatment is being used, researchers may do a Phase IV study.
Phase IV studies look at whether the treatment is useful for other conditions or if it has any long-term side effects.
Ramona Lione moved from Fremont to San Jose many years ago but continued going to Washington Hospital Healthcare System (WHHS) for her mammograms. She ...
Continue ReadingProstate cancer is one of the most common forms of cancer for men, but how to deal with it and what it involves remains unclear for many. It is a ...
Continue ReadingA Retired Washington Hospital Employee Shares Her Story Though Faith Rasmussen retired to Grass Valley in 2016, she made trips back to Fremont to ...
Continue ReadingYour most recent mammogram report came back indicating areas of concern that could be breast cancer. Your physician recommended a needle biopsy to ...
Continue ReadingBrentwood Woman Benefits from Latest Advances in Cancer Treatment After battling breast cancer for nearly a year, Diana Sacramento was finally able to ...
Continue ReadingEvelyn Salindong was all set to visit family in the Philippines in January, but she had to cancel the vacation hours before her plane lifted off. That ...
Continue ReadingMany people know that early detection of breast, colon and prostate cancer can help save lives. Smokers also need to know that a screening test for ...
Continue ReadingSeventeen years ago, Kathleen Reen beat breast cancer. Surgery, chemotherapy, radiation and a positive attitude were her weapons of destruction and ...
Continue ReadingGetting Through Cancer Treatment Carla Greene’s hair fell out on July 3, 2022. “First, I cried,” she recalls. “Then I dried my tears, put on a scarf, ...
Continue ReadingPatient visits to the UCSF – Washington Cancer Center have grown exponentially in recent years, demonstrating the need for visionary planning to ...
Continue Reading