While browsing through our list of open cancer clinical trials, you might notice that some are labeled with phases that graduate from Phase 0 to Phase 4. If you’re interested in participating in a Phase 1 trial but aren’t sure what the process might involve or what to expect, Regional Cancer Care Associates’ quick overview of this type of cancer clinical trial can help you make a more informed, confident decision.
Trials are categorized into phases based on the type of information gathered. For example, Phase 0 studies are typically just for exploratory research, while Phase 4 studies usually look at drugs that have already been approved by the U.S. Food and Drug Administration (FDA). Each study builds on the knowledge gained from previous studies.
In a Phase 1 study, an investigational treatment is given to humans, often for the first time. Extensive research has already been done and the drug has been tested in the laboratory, but now it’s time to see how safe and effective the agent is for humans. The main goal is to determine the impact of a specified drug on the human body and how it interacts with that drug.
In general, Phase 1 studies help researchers figure out the best dosages to give to patients with cancer. In the process, they also help identify any potential side effects of a new drug, although at this phase rare side effects can be more difficult to detect. The results of Phase 1 studies can then be used to get a better understanding of the drug and how doctors can use it to help current and future cancer patients.
Phase 1 cancer clinical trials often involve only a small group of people, and it’s common for them to have different types of cancer. Researchers start by administering extremely low doses to patients and then gradually introduce higher doses. There are no placebos (dummy pills) in Phase 1 trials, which means every participant receives the new drug.
Going into Phase 1 cancer clinical trials, some participants may feel apprehensive or fearful. But it’s important to know that these trials are safe and you’ll be closely monitored for side effects the whole time. Plus, the screening process helps verify whether you’d be a good candidate for the trial. If you have any questions, always reach out to your doctor.
Interested in learning more about cancer clinical trials? If you would like to take part in a trial, RCCA offers a complete list of all available Phase 3 studies. To learn more, review our current list of all clinical trials, contact one of our 30 locations throughout New Jersey, Connecticut, and Maryland or call 201-518-3587 for additional details.
Regional Cancer Care Associates is one of fewer than 200 medical practices in the country selected to participate in the Oncology Care Model (OCM); a recent Medicare initiative aimed at improving care coordination and access to and quality of care for Medicare beneficiaries undergoing chemotherapy treatment.