Clinical Trials

Clinical trials test new methods of finding, treating, and preventing cancer. They also help doctors improve the quality of life for people with cancer.

Today, people are living longer lives thanks to previous cancer clinical trials. Participants in clinical trials add to what is known about cancer and how to treat it.

People with cancer and healthy volunteers join trials to play a role in cancer research and move science forward to help others.

Treatment Trials include people who have cancer and they test new treatments or new approaches to existing treatments.

Prevention Trials study approaches to prevent cancer. In most prevention trials, the people who take part do not have cancer, but are at high risk for developing it. Or they have had cancer and are at high risk for developing a new cancer.

Screening Trials aim to test ways to find cancer before it causes symptoms and could be easier to treat.

Each clinical trial has specific requirements, called eligibility criteria, that must be met to be accepted. Those criteria could include a person’s relative health, medical history, family medical history, age, gender, risk factors, past treatments, and specifics about a tumors genetic changes. The criteria helps create a cohort, or group, who are similar in specific ways to help isolate results as being related to the treatment being tried.

In a phase 1 clinical trial, researchers figure out whether a new treatment is safe, what its side effects are, whether people can tolerate it, and the highest dose that people can tolerate. These trials are done in a small group of people (around 15 to 30). They also make sure a treatment affects the cancer.

A phase 2 clinical trial includes more people (50 to 100) to see if the new treatment seems to work against the cancer, such as by shrinking tumors or slowing their growth. Researchers want to see how the new treatment affects the body and fights cancer. In this phase, teams continue to study safety, including short-term side effects.

In a phase 3 clinical trial, researchers compare the treatment to the current standard therapy to see which works better. They also compare the side effects of the treatments. Participants are randomly assigned to one of the treatments to ensure that any differences are real and not the result of differences in the people in each group. Phase 3 trials include large numbers of people (from 100 to several thousand) to make sure that the result is valid.

Results from phase 1–3 trials are used to make decisions about approving new treatments or existing treatments for new conditions by agencies like the US Food and Drug Administration (FDA).

A phase 4 clinical trial looks at long-term safety and effectiveness that take place after a new treatment has been approved by the FDA and is available to the public. Treatment effectiveness and safety are monitored in large, diverse populations. More information is gathered as more people use the drug or device over a longer period of time.

The Early Phase Clinical Trial Infusion Center at Smilow Cancer Hospital opened in 2016 at 55 Park Street in New Haven, and is a dynamic hub of early phase trials. Attractive and state-of-the-art, the Center is at the heart of Yale Cancer Center’s Early Phase Clinical Trial Program and is dedicated to the care and treatment of patients on early phase clinical trials.

Under the leadership of Patricia LoRusso, DO Associate Director, Experimental Therapeutics, Yale Cancer Center, and Director of the Early Phase Clinical Trial Infusion Center, the Early Phase Clinical Trial Program affords patients hope, as well as the ability to participate in research with clinical impact – research that will advance new drugs, potentially leading to FDA approval.

The Early Phase Clinical Trial Program at Yale Cancer Center has a portfolio of early phase trials open to accrual; with the number of studies continually increasing. Among the most exciting of trials being conducted are first in-human, with some trials focusing on novel targets and other unique mechanisms in advanced solid tumors, which would have significant advancement for targeted therapeutics. Trials such as these have grown and developed Yale Cancer Center’s reputation for innovation in the immune-based therapy space.

For more information please call 203.200.2486

The laboratory was established because of the growing number of newly developed drugs that target specific mutant proteins within malignant cells or that target critical biochemical pathways that have been altered within malignant cells as a result of mutations acquired during tumorigenesis.

Malignant cells may also possess mutations that render a tumor resistant to drug treatment, either because the mutation prevents a drug from binding to its target or because the mutation renders tumor growth independent of the protein targeted by the drug.

Lab Director: Sanja Dacic, MD, PhD
Phone: (203) 688-5588