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Phase I Clinical Trials – A Necessity in the Advancement of Cancer Therapies

Dr. Anthony Tolcher, medical oncologist and co-founder of NEXT Oncology has said, “We are going to make cancer treatable or curable in my lifetime.” For that to happen, scientists, physicians and patients must come together to develop and test the latest anti-cancer therapies. And this begins with Phase I oncology clinical trials.

What are Clinical Trials?

Clinical trials are the final step in a long process that begins with research in a lab. Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. Phase I clinical trials are research studies that test how well new medical approaches work in people and are usually the initial testing of a new treatment. Each study answers scientific questions focused on finding better methods to prevent, screen, diagnose or treat cancer.

Drug development for new cancer treatment occurs in a series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. In phases 1 and 2, researchers figure out whether a new treatment is safe, what its side effects are, how the treatment should be given, and the best dose of the new treatment. They also make see how the treatment affects the human body and fights cancer, ensuring that the treatment has some benefit, such as slowing tumor growth and extending life. During phase 3, researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid.

How do Clinical Trials Work and Why are They Important?

Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the trial, called a protocol. The protocol explains what will be done during the trial. It also contains information that helps the doctor decide if this treatment is right for a patient.  

Any time a patient needs treatment for cancer, clinical trials are an option to think about. Trials are available for all stages of cancer, not just those with advanced cancer that is not responding to treatment.

Today, because of research and clinical trials, people are living longer lives due to successful cancer treatments that began as clinical trials. Clinical trials also help us find new ways to prevent and detect cancer. And they help us improve the quality of life for people during and after treatment. Participation in a clinical trial helps physicians and patients understand cancer and help improve cancer care for future patients. Clinical trials are the key to making progress against cancer.

To learn more about NEXT Oncology and its mission to provide patients access to advanced cancer treatments and clinical trials, please call (210) 580-9500 or send a message here.


NEXT Oncology | Located in San Antonio, Texas

Phases of Cancer Clinical Trials – National Cancer Institute

Phases of Clinical Trials | Cancer.Net