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Innovative Program Brings the Clinical Trials to the Patient

Clinical trials are a key component in developing and approving new cancer drugs – and getting them to the patients who need them. Providence Regional Cancer Partnership in Everett, Washington, recently joined with pharmaceutical company Novartis Oncology to offer patients the opportunity to participate in clinical trials in a new and innovative way: the Novartis Signature Program.

The existing model for clinical trials involves screening patients by cancer diagnosis (lung cancer or breast cancer, for example). The Novartis Signature Trial program instead screens patients by identifying the genome of the cancer and then screening by potential targets within the cancer cells themselves.

There’s More to Cancer Than the Disease Site

Researchers have learned that what’s key to categorizing and treating cancer isn’t its location in the body, but the genetic mutation that causes the cancer itself. Just because two patients both have lung cancer, it doesn’t mean they share the same genetic mutation at the root of the disease process.

Enter “targeted therapy,” where medications are developed to combat a specific genetic mutation responsible for a particular cancer. Given this approach, therapies targeted at a specific mutation wouldn’t work for every patient – even if they had the “same type of cancer.” They must also share a common genetic mutation. Targeted therapy drugs also only affect cells with the specific mutation. Most often, that means healthy cells are spared, which could lead to fewer treatment side effects.

With the development of drugs targeted to a particular gene mutation, finding patients to participate in trials became even more difficult. Drug companies would open a clinical trial at a particular facility and wait for patients to enroll. Only 3-4% of cancer patients nationwide are enrolled in clinical trials. It could take a super motivated doctor or proactive patient to even find a trial.

Signature Program Reverses the Process, Brings Clinical Trial to the Patient

The Novartis Signature Program flips the clinical trial process upside down. Instead of waiting for a patient to come to the drug protocol, the protocol comes to the patient. Here’s how:

A patient is diagnosed with cancer and receives at least one treatment protocol without success. The cancer care team may then take the cancer tissue samples and send them to a certified lab for molecular and genetic analysis. If the subsequent report indicates there’s an actionable genetic mutation, the research doctor contacts the Signature Trial administrators. The administrators confirm there is a study drug showing effectiveness for the specific genetic mutation and match the patient to a clinical trial.

If the cancer care center has been preapproved for the Signature Trials program – and Providence Regional Cancer Partnership has – then, Novartis opens the study and sends the trial medications to the patient.

“This is a really exciting and innovative program,” says Marilyn Birchman, Clinical Research Manager at Providence Regional Cancer Partnership. “As oncology care becomes more personalized, there are more treatments specific not only to the type of cancer, but to the gene expression of the cancer cells. The Signature Trial program can quickly match a patient with an investigational, targeted medication that could be effective to treat that specific cancer.”

The Signature Trials program is patient-triggered and target specific. There are no geographical boundaries and trials can be initiated quickly. Plus, Novartis analyzes results in real-time and can often gauge the benefits of particular treatments faster than with the previous model. This is all good news for patients fighting cancer.

More and more cancer care centers are participating in the Signature Trials program all the time. And, many cancer care centers are working on their own clinical trials, as well. If you’re interested in finding out if you’d be a good fit for a clinical trial, talk to your cancer care team.

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