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The Novartis Signature Trial Program is an innovative series of clinical trials that is currently recruiting patients using a targeted screening approach to precisely match patients with investigational treatments based on their distinct tumor profiles.
By not limiting testing to a single cancer type, the Signature trial approach allows patients to receive treatment with investigational targeted therapies, and allows researchers to more rapidly evaluate the full clinical potential of these investigational drugs.
What are the benefits of the Signature trial approach?
How does Signature differ from traditional clinical trials?
The Signature Clinical Trial Program is a US-based pilot developed by Novartis, which aims to change the traditional clinical paradigm by bringing the protocol to the patient through the identification of certain genetic mutations.
Traditional Clinical Trials
Sites can take about 8 months to open a trial 1
Participation is limited to a fixed number of sites
Each site must enroll multiple patients
Many patients need to be screened to identify eligible patient 2
Site is identified, activates trial, and then recruits eligible patients
Criteria are limited to one tumor type
Many patients must be enrolled; data are analyzed upon availability of final results
Signature Trial Program
Site can be open in approximately 3 weeks 3
No fixed number of sites 3
Site can enroll one or multiple patients 3
Patient preidentified, no screening necessary 3
Patient is identified at site; then study is activated. Program is actively seeking new sites 3
Patients with any tumor type and relevant genetic mutation can enroll 3
Fewer patients can be enrolled, and data are analyzed on a frequent basis 3