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Clinical Trials Fact Sheet

 What is a Clinical Trial?
Clinical trials are research studies conducted with patients that test new options to treat, prevent, detect and diagnose diseases. Regulations at both national and international levels are in place to protect the safety and well-being of patients and to ensure trials are conducted to strict, ethical and scientific principles.

Key Questions Answered
1. Why are clinical trials important?
These trials are research studies that involve people. Patients who participate in clinical trials are contributing to scientists’ knowledge of treatments and procedures and are aiding in the development of improved treatments.

2. Are there different types of trials?
Yes; clinical trials differ based on their primary purposes, which are the following:

  • Treatment: These trials test the effectiveness of current treatments or new treatments; combinations of treatment types may also be tested.
  • Prevention: Preventative trials test new interventions to lower the risk of developing certain diseases.
  • Screening: These test new ways of detecting diseases early
  • Diagnostic: These trials study new tests and procedures to assist in identifying and diagnosing conditions more accurately.
  • Quality of Life/ Supportive Care: These trials focus on the comfort and quality of life of patients with certain conditions and often look for new ways to decrease the severity of side effects of ailments and their treatments.


3. Who Sponsors Clinical Trials?
Government agencies such as the National Institutes of Health (NIH) and the National Cancer Institute (NCI), along with physicians, foundations and pharmaceutical and biotechnology companies sponsor clinical trials.


4. Where do clinical trials take place?
These trials take place in doctors’ offices, medical centers, clinics and community hospitals across the United States and in other countries. A trial can be conducted at one medical center or multiple locations at once.


5. Who manages clinical trials?
A research team of doctors, nurses, researchers, data analysts and specialists will work closely with medical professionals to monitor patient health and ensure the reliability of the trial’s results.

 
6. How is trial eligibility determined?
Each trial has a protocol, or trial blueprint that outlines the trial process and who is allowed to participate. The eligibility criteria in the protocol will determine the characteristics all interested parties must have to participate in the study.

7. What about patient safety?
Our number one commitment at YRMC is to the patient and their safety. National and international regulations are in place to protect human subjects and ensure studies follow ethical, scientific guidelines.

Trials conducted by the U.S. federal government that evaluate drugs, treatment procedures and devices that will be regulated by the Food and Drug Administration (FDA) must be approved by an Institutional Review Board (IRB). The IRB must have at least five members and it reviews all aspects of the trial to ensure patient safety and will review the trial at least once yearly to determine whether to continue a trial.
To ensure the effectiveness of the data collected during a clinical trial, occasionally there is a Data and Safety Monitoring Board (DSMB) to monitor the effectiveness of the data collected during the trial. The doctors and statisticians on the DRMB are separate from the sponsors of the trial and the IRB.


8. What is Informed Consent?
This is an informational opportunity for all interested parties to learn the facts about a clinical trial. At the initial informed consent session, there will be a form for participants to sign; however, this signature does not bind a participant to remain in a trial by any means. Participants may leave a trial at any time once cleared for safety by the research team. 

If anything changes during the course of the trial, researchers will host another informed consent session and may have participants sign another form to continue the study.

9. What are the benefits of participating in a clinical trial?
• Access to new treatments and procedures
• The possibility of receiving more effective intervention
• Receiving regular, careful medical attention from the research team
• Results may help future patients
• Assisting with expanding medical and scientific coverage

10. What are the potential dangers associated with participation?
• Studied treatment may not be as effective as standard treatment
• Trial participants may have more medical visits
• Health insurance may not cover patient costs


11. Who is responsible for the costs?
There are two categories of care costs:
• Routine Care Costs
• Research Costs
Routine care costs are usually covered by health insurance but can vary by state and health insurance plan coverage. Research costs are usually covered by the trial’s sponsoring organization.

Anyone interested in participating in a trial should check with their health insurance company to discuss routine care coverage.

Federal programs that pay for care costs in trials:
• Medicare
• TRICARE
• Department of Veterans Affairs


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