The Moffit Cancer Center has received a new patent for a computerized system that efficiently matches the right patient with the right clinical trial. The newly patented system’s database contains thousands of patient-donated biological tissue or tumor samples, and can rapidly match a registered patient’s personal molecular profile to the molecular design of the drug that aims to target their disease at the molecular level. The system can potentially speed up clinical trials and assist in reducing the time for gaining market approval for critically needed new drugs.

Gaining market approval for newly developed cancer fighting drugs, or for other serious diseases, can take an average of 15 years, due to the long and complex process of developing new drugs. The three-phase clinical trials process, which accounts for about half of those 15 years, often creates a bottleneck for supplying innovative drugs to those who need them.

Clinical trials are becoming more and more expensive are very complex. For instance, patients eligible to participate in the trial because of their age or stage of disease may or may not prove to be the best candidates to test a drug in the long-term. The process is slowed down if the trial reveals adverse events, changes in a patient’s state of health and a drug proving non-effective in patients.

Even though patients may have met the trial protocol’s criteria, the drug may not prove to be the best for a particular patient as their molecular profile does not provide a good match for the chemical and molecular properties of the drug.

The concept of administering personalized medicines is choosing the right drug for the right patient, however it needs innovations to realize this concept and personalizing the selection process for clinical trials marks a crucial step towards the goal.

As new and better ways of examining and understanding a tumor’s molecular profile are being developed, matching the right patient to the right clinical trial becomes vitally important, however, processing the vast evaluation of data needed to accomplish this has been a major hurdle.

The new computer system, patented under Number US 8,095,389 B2, or “Computer Systems and Methods for Selecting Patients for Clinical Trials,” has been developed to overcome this hurdle with its novel design to:

  • Select patients to clinical trials by matching an individual’s/drug’s molecular profile
  • Match patients to clinical trials through patient’s disease/diagnosis
  • Match patients to clinical trials according to their symptoms
  • Match patients to clinical trials according to their demographic information and family history, and
  • Track a clinical trial participant’s disease progression compared to drug efficacy

The newly patented computer system, together with its related products, that include an operating system, software, interfaces and data retrieval system, can improve clinical trial selection efficacy due to a less randomized and more specific selection process. Furthermore, it could potentially improve clinical trials by avoiding bottlenecks and enhancing the selection process, as well as reducing the timeline, which ultimately means that new drugs will be available on the market more rapidly and more efficiently.

Written by Petra Rattue