Bringing the Clinical Trial to You - Novartis' Signature Clinical Trial Program

It is critical that patients enroll in clinical trials, yet it can be a challenge when a trial isn't offered close to home. The cost of running a clinic trial is equally challenging with trials costing upwards of $300 million. Doctors can also hesitate to suggest a clinical trial at another facility if it means sending the patient away for care elsewhere. Novartis has a new clinical trial program called the Signature Clinical Trial program that hopes to overcome these challenges while giving patients true "personalized medicine."

In a recent article Targeted Oncology, the new program is described as being more convenient for doctor and patient, providing quick setup of a clinical trial where even one patient can join.

"Under the Signature program, instead of opening a fixed number of sites at specified locations, Novartis will establish a trial site wherever an eligible patient is identified. Once a physician determines that a patient’s cancer has a one of the qualifying mutations, he or she calls a Novartis Signature trial administrator to discuss opening a site. Any “research-experienced site in the United States accepting [the Novartis] study model” is able to participate. Normally, it takes around 8 months to get a trial site operational6; Novartis expects it to take no more than 3 weeks to open a Signature site.2 Whereas a traditional trial site must enroll multiple patients, a Signature site has no requirement to enroll anyone beyond the initial patient."

The trial is truly personalized medicine, targeting specific genetic mutations with targeted drugs. Once a patient is screened for that mutation, they can request to participate in the trial.

The genetic targets that are cross-cancer (and other diseases) include:

• FGFR alterations
• PI3K activation
• EGFR, PDGRF, VEGF, cKIT, FLTC CSFR1, Trk, RET mutations or translocations
• RAS, RAF, MEK activation
• BRAFV600 mutation
• CDK4/6 pathway
• ALK or ROS1 abberations
• PTCH1 or SMO mutations
• TNF-IR (psoriasis)

While not all myeloma patients exhibit these mutations, it is worth asking your doctor how to screen for these to know if you are eligible.

To read the full article, click here.