RESEARCH TRIANGLE PARK, NC--(Marketwire - September 15, 2010) -  The recent changes in the way uninsured and underinsured Americans get healthcare has the potential to add 30 million people to the clinical trial recruitment pool, according to new findings from consulting firm Cutting Edge Information.

The uncertainty about reimbursement for primary care has exacerbated problems in meeting enrollment goals in the United States. According to executives interviewed for the newly released study, "Clinical Trial Patient Recruitment: Accelerate Enrollment, Increase Retention and Reduce Costs," enrollment difficulties are especially tough in niche therapeutic areas for which patients are in high demand.

"Typically, the clinical trial sponsor pays for investigational drug administration and subsequent tests for data gathering," said Jason Richardson, president of Cutting Edge Information. "But reimbursement for medical check-ups, hospital stays, blood tests, x-rays, or other regularly scheduled care falls to the patient's insurer."

According to the National Cancer Institute, over half of states have some legislation requiring the coverage of routine medical care for clinical trial participants. These requirements vary greatly among the states. For example:

*North Carolina requires the coverage of routine medical care by insurers for Phase II, III and IV trials.
*New Jersey regulations cover all phases of clinical trial but are reserved only for cancer patients.
*Texas covers the reimbursement of routine medical care for all phases of clinical development.

The new federal mandate requires all payers to cover routine care costs for patients who participate in clinical trials for the prevention, detection and treatment of cancer and other life-threatening diseases.

This will potentially make recruiting for oncology clinical trials quicker and easier. Starting in 2014, clinical teams will not have to manage fifty different sets of rules to determine where participants will be reimbursed. And patients will not face the demotivator of unknown costs when making the decision to participate in a clinical trial.

"Clinical Trial Patient Recruitment: Accelerate Enrollment, Increase Retention and Reduce Costs" ( examines patient concerns such as reimbursement, as well as other opportunities to improve clinical recruitment and retention. 

Cutting Edge Information ( serves the Life Science industry. For more information about clinical trials management, contact Elio Evangelista at 919-433-0214 or For media information, contact Stephanie Swanson at 919-433-0212 or

Contact Information:

Stephanie Swanson