Clinical Trials

Every clinical trial has criteria that patients must meet before they can be enrolled. Considerations of eligibility for a study can require specific information about the person's condition and previous treatment and additional criteria that may not apply to you. As such, it is often helpful to have your healthcare provider make the initial contact with the group performing the trial to obtain a complete list of eligibility criteria.

However, clinical trials conducted at High Point Regional Health System cannot work without patient participation. Without a sufficient number of participants, a clinical trial could be held up for months, if not years, delaying the availability of a potential breakthrough in treatment.

By enrolling in a clinical trial, you can not only help yourself, but also the millions of patients around the world who may benefit from your participation.

How do I get involved?
Every clinical trial has criteria that patients must meet before they can be enrolled. Considerations of eligibility for a study can require specific information about the person’s condition and previous treatment and additional criteria that may not apply to you. As such, it is often helpful to have your healthcare provider make the initial contact with the group performing the trial to obtain a complete list of eligibility criteria.

To be considered for a clinical trial at High Point Regional, please discuss clinical trials in general and specifically any clinical trial you believe you may be eligible for with your primary care physician or specialist. It may be helpful to provide them with a print-out of the page showing the trials related to your situation or condition.

Who conducts them?
Clinical trials conducted at High Point Regional Health System are sponsored by organizations, institutions, pharmaceutical and biotechnology companies, the government, and nonprofit groups seeking to improve current treatment or provide new methods of preventing, detecting, or fighting disease.

What are the potential benefits?
A well-designed clinical trial can offer patients benefits such as:
• Access to therapy and drugs not yet available to the public.
• Treatment provided by leading physicians.
• Careful monitoring of your condition and treatment.
• The ability to take a more active role in your own health care.
• An opportunity to help others by contributing to medical research.

Are they safe?
All clinical trials must be approved by the federal government and adhere to strict regulations protecting the rights of participants. To help ensure the relative safety and effectiveness of the treatment, each clinical trial must undergo preclinical testing (e.g. cell studies and animal testing before large-scale testing in people may begin). However, as with any treatment, there are inherent risks. There may include:
• The new therapy may not be as effective as previous research
   indicated.
• Unexpected side effects.
• The study may require more time and effort than the standard
   treatment.

Will my insurance cover it?
While insurance coverage does vary, most insurance companies pay for routine tests, treatment and doctor visits they would cover if you were not in the trial. Costs for special testing, additional doctor visits and the treatment itself are usually paid for by the trial sponsor. In some cases, participants may even be compensated for their time and mileage.

What questions should I ask about the clinical trial?
• What is the purpose of the study?
• What are my other options for treatment?
• What are the advantages and disadvantages of the drug/procedure
   vs. the standard of care?
• What kinds of treatments and tests does the study involve?
• How often are they performed?
• What are my responsibilities during the study?
• Will this require extra time or travel?
• How could the study affect my daily life?
• What side effects might I expect?
• Will I still be seeing my regular doctor?
• Who will be in charge of my care?
• Will my insurance cover it?
• Will I have to pay for any part of the trial?
• If I am adversely affected by the study, am I entitled to treatment?
• How long will I remain in the study?
• Is long-term follow-up care part of the study?
• Can I choose to continue treatment after the study ends?
• Can I talk to some other people in the study?

For more information about clinical trials at High Point Regional Health System, review the trials currently in progress, email sfairchild@hprhs.com, or call Sue Fairchild at (336) 878-6207.