GRACE is committed to providing the most up-to-date information regarding cancer diagnoses for our community.
We realize an active ongoing discussion always surrounds Clinical Trials - What are they, who runs them, how do you become a part of one.
We have partnered with EmergingMed.com to provide to you the GRACE Clinical Trial Navigation Service. Accessing this information via the GRACE site will take you to a private and secure page where you will be asked to fill out a short questionnaire. This clinical trial database includes treatment trials from clinicaltrials.gov and updates from sponsors.
What is a Clinical Trial?
A clinical trial or study (sometimes called interventional studies) involves research using people who volunteer to participate that adds to the medical knowledge about that study. In a clinical trial, volunteers receive specific interventions according to a protocol created by the investigators for that trial. Interventions can be medical products (drugs or devices), procedures, or changes to a participants behavior. Outcomes are measured to determine safety and effectiveness. Clinical trials have standards or eligibility criteria outlining who can participate, and all clinical studies are led by a principal investigator, most often a medical doctor.
It is important that the participant's usual health care provider work with the research team so participants can make sure that the study protocol will not conflict with other medications or treatments being received.
What are the Four Phases of Clinical Trials?
There are four phases of a clinical trial, defined by the FDA, in order to test a treatment, find dosages, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, it goes for FDA approval for clinical use, and the FDA continues to monitor its effects.
The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
A Phase I trial - Safety and Side effects. Phase 1 tests an experimental treatment on a small group of often healthy people (20 to 80).
A Phase II trial - Effectiveness. Phase 2 tests generally involve more people (100 to 300). Phase 2 goals are to obtain preliminary data on whether the drug works in people who have a specific disease or condition. Safety and short term side effects are still studied in in Phase 2. This phase can last several years.
A Phase III trial - Safety, Effectiveness, Different Populations, Different Dosages and Combinations. Phase 3 continues to gather information about safety and effectiveness, with a deeper look at different populations and different dosages, and using the drug in combination with other drugs. The number of people usually ranges from several hundred to approximately 3,000 people. After this stage, if the FDA finds that the trial results are positive, it can approve the experimental drug or device.
A Phase IV trial - Drugs or Devices after FDA Approval. During Phase 4 trials, a device or drug's effectiveness and safety continued to be monitored in large, diverse populations. Side effects and safety sometimes are not clear until the drug has been available for a longer period of time.
To review active clinical trials, please visit the GRACE Clinical Trial Navigation Service.
For more detail on clinical trials, please visit