This document discusses navigating patients to clinical trials. It defines what clinical trials are, which include testing new interventions to treat disease, assessing safety of new drugs, and evaluating quality of life. It outlines the different types and phases of clinical trials. It then specifically discusses the clinical trials available at Florida Hospital Cancer Institute, the benefits of participating in clinical trials, and how to navigate patients to clinical trials by being an advocate, calling the research department, and overcoming barriers like lack of awareness or access issues.

1. Navigating Patients to
Clinical Trials
Cameron Richardson, RN, BSN, OCN
Nurse Manager, Clinical Research at Florida Hospital
Cancer Institute

2. What is a Clinical Trial?
Effectiveness of intervention to treat a disease
Safety of a new drug
Defining dose administration
Testing drug formulation
Exploring combination therapies
Evaluating effect of therapies on quality of live

3. Types of Clinical Trials
Treatment: Test new approaches to treat a disease
Prevention: What approaches can prevent disease
Early-detection/screening: What are new ways to find hidden disease
Diagnostic: How can new tests or procedures identify disease

4. Phases of Clinical
Trials for Drug Development
Phase 1 Phase 2 Phase 3 Phase 4
No. of Patients 15-30 <100 100 to thousands Several hundred to
several thousands
Purpose First in humans
(find safe dose)
Determine efficacy Compare new agent
with standard
treatment
Post-market
Long-term safety and
efficacy

5. Clinical Trials atFlorida Hospital CancerInstitute
https://www.floridahospital.com/orlando/cancer/clinical-trials

6. Clinical Trials at Florida Hospital Cancer
Institute (cont)

7. Clinical Trials at Florida Hospital Cancer
Institute (cont)

8. The Benefits of Clinical Trials
gaining access to new treatments that are not yet available to the public.
obtaining expert medical care at a leading health care facility.
playing an active role in your own health care.
helping others by contributing to medical research.

9. Navigate Your
Patients to
Clinical Trials
1. Be a patient
advocate………mention clinical
trials
2. When in doubt…….call the
research department

10. Quick Facts to Remember Clinical Trials
• Patients will usually receive Novel agents the are not available otherwise
• The one-on-one care received from Research staff (Research Concierge)
• Clinical trials do not equal placebo
• In clinical trials, the benefit must outweigh
• We are contributing to medical research for us and for the future
• Clinical trials save lives and/or prolong survival

11. Barriers to Adult Participation in Clinical
Trials
Patients may be unaware of clinical trials
Lack of access to trials
 Have practical or personal obstacles such as transportation, daycare or work
schedules
Fear, distrust, or be suspicious of research

12. Q&A