Clinical Trials

Three principal barriers to cancer clinical trials:

Protocol

Under the National Comprehensive Cancer Network (NCCN), the eligibility criteria for clinical trial enrollment is too stringent and marginalizes people. Although this is improving, especially with NCI working with American Society Clinical Oncologist (ASCO), there are harsh limits on those eligible for human clinical trials.

Healthcare provider barriers

Many eligible patients do not have adequate health insurance to financially support them entering a clinical trial. Additionally, many patients in rural and poorer areas must cover significant distances out of pocket to participate in clinical trials.

Healthcare coverage barriers

Cancer centers and community-based oncologists cannot cover the costs of their clinical trials because of inadequate funding.

“The best treatment for any cancer patient is on a clinical trial.”

DR. ROBERT S. MANNEL
Director, NCI Designated Stephenson Cancer Center
Oklahoma University

CanceRx goal is to bolster a robust clinical trial system that can move the new drug patents flowing out of the basic research phase into patient care. This would significantly improve cancer survivorship in the foreseeable future.

CanceRx acknowledges the importance of NCCN eligibility criteria and may not have the resources to change overall patient eligibility or influence insurance companies. However, CanceRx is designed to inject much-needed funding to overcome the most challenging healthcare provider and system coverage barriers.

CanceRx provides a new application of finance to improve healthcare system barriers to human cancer clinical trials.

The model minimizes overall patient numbers and timeframe of clinical trials through cooperative partnerships with leaders in the field of Model Informed Drug Development (MIDD) and Quantitative Systems Pharmacology (QSP). These advanced analytical and statistical partners will help CanceRx more accurately choose the most promising clinical trials to invest in, lower the number of necessary eligible humans per clinical trial, and shorten the overall term of the clinical trial. This will allow CanceRx to minimize barriers and accelerate the delivery of cancer therapeutics to patients.

The model increases funding for promising clinical trials to bring trials to patients, not patients to trial sites. Access and the cost of participation is a provider issue, not a patient issue.