A cancer diagnosis may cause stress and worry, but the exponential increase in effective, available treatment options over the past 20 years has provided new hope to patients and their families. And still, more promising new treatments are on the horizon, in development through clinical trials.
Clinical trials are conducted in Phases 0 through 4, and each phase plays a different role in moving a treatment from experimental to approval by the U.S. Food and Drug Administration. If you’ve been offered the opportunity to participate in a Phase 2 study at Regional Cancer Care Associates, here’s everything you need to know before accepting.
Cancer clinical trials are scientific studies developed by doctors to explore new diagnostic and treatment avenues for a specific disease. These studies can be used to determine the effectiveness of potential cancer treatments and measure their safety for patients. All trials are voluntary, and the people chosen to participate must meet certain criteria that match the type of study being conducted. Because the treatments being tested are still under development, all clinical trials carry some level of risk, and there is no guarantee the treatments will be effective. However, your doctor can help you evaluate the benefit of participation and help you feel confident in your decision.
Clinical trials are broken down into multiple phases that answer different research questions. After a Phase 0 study answers exploratory inquiries and safety has been determined in Phase 1, the goal of Phase 2 studies is to find out if the new treatment works. There are many ways to measure effectiveness, such as:
Aside from the main research question of treatment effectiveness, Phase 2 medication studies set out to answer several additional questions about optimal medication dosing and tolerability. Phase 2 studies will involve anywhere from 25 to 100 participants, all of whom will usually take the same dosage of the medication being studied or follow the same treatment specifications.
Sometimes, random groups will be selected to take different amounts of medication to see which dosage is the most effective. Because the study’s main purpose is to determine a treatment’s effectiveness, everyone is administered the real treatment to maximize the amount of data collected; dummy pills, known as “placebo,” are not administered in this phase.
Another benefit of Phase 2 studies is that less-common side effects are more likely to appear in a larger group of participants than in a smaller study group. This gives researchers a more complete picture of how the treatment affects patients overall.
Clinical trials give patients like you expanded options in the fight against cancer. At the same time, you’ll be part of a search for treatments that could help more patients like you in the future. If you would like to take part in a trial, RCCA offers a complete list of all available Phase 2 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.