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.
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about the author
Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of HealthTree Foundation (formerly Myeloma Crowd).