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About Signature

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?

  • Patient-triggered: The Signature series of trials are target-specific and tissue-agnostic, and allow patients greater access to investigational treatments that specifically target their tumors' genetic alterations
  • Less operational burden: Signature trials are fast to open and there are a few restrictions on the locations of the sites and no pre-defined number of sites
  • Brings the protocol to the patient: Signature trials bring treatments to patients sooner than might otherwise be available

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

 

  1. Tufts, CSDD. Survey Results of Start-Up Cycle Times. http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=796689. Published November 1, 2012. Accessed April 2, 2014.
  2. Screening Tests Prior to Study Enrollment - Information Sheet. U.S. Food and Drug Administration. http://www.fda.gov/RegulatoryInformation/Guidances/ucm126430.htm. Updated June 25, 2014. Accessed April 7, 2014.
  3. Data on file. Novartis Pharmaceuticals Corp; 2014.