Clinical Trials Patient Studies
Phase 3 clinical trial costs can exceed $26,000 per patient and may be the greatest cost and barrier to getting new drugs into the market. These trials typically require over 1000 patients each in order to meet regulations and have enough data to demonstrate statistically significant efficacy of the drug as compared to placebo and alternatives. For every patient that is in the trial but ultimately will not show positive response to the test drug, there may need to be an additional 3-4 patients added to the trial to compensate for the negative response.
The MatchTx cloud solution (hosted algorithms with reference data) will enable adaptive clinical trial protocols where early stage trial and ongoing clinical outcomes will be used to drive models of what non-responders ‘look like’ (genetic profile) to MatchTx as additional data are produced in the study so that prospective participants can be screened and classified ‘out’. Screening out 20 patients from a Phase III trial could eliminate a total of 80 recruits from that trial, saving $2 Million, minimize adverse events, and help get the drug to market sooner.
Example MatchTx Output – discovery of matching rules from patient analysis, disease and outcome sets (shows classes of genes that are mutated, patients by gender, race, status, de-identified ID).
For certain cancers there are specific marker combinations (cancer type, specific genetic markers) that correlate well to optimal treatment. For many others today, it is a trial and error system that ends poorly for many patients.
MatchTx provides an adaptive learning software system that utilizes big biomedical data in a new way to (1) improve outcomes for trials, (2) identify new biomarker patterns for development of personalized medicines, (3) enable repositioning of failed drugs, and (4) ultimately enable personalized cancer treatment.