SLIDE 1
PARTICIPATING IN RESEARCH: CLINICAL TRIALS AND REGISTRIES
BOBBY KWANGHOON HAN, MD JENNIFER SCHAEFFER, BS, CCRC SARAH H. CHUNG, MD, MS UNIVERSITY OF WASHINGTON DIVISION OF RHEUMATOLOGY 5/7/2020
SLIDE 2 TYPES OF RESEARCH IN RHEUMATOLOGY
BASIC SCIENCE CLINICAL POPULATION TRANSLATIONAL QUALITATIVE
Animal studies Disease mechanisms Clinical trials New intervention Epidemiology Large databases Associations/trends Basic Science ↔ Clinical Care Experiential data Patient-reported outcomes Survey data
SLIDE 3 WHAT IS TRANSLATIONAL RESEARCH?
findings to clinical care
clinical care to the lab
SLIDE 4 WHY IS TRANSLATIONAL RESEARCH IMPORTANT?
study conditions
- Potential to provide more
tailored clinical care
- Keeps clinically-pertinent
research questions at the forefront!
SLIDE 5 WHAT ARE POPULATION STUDIES?
- Trends in disease
- utcomes
- Factors that affect
disease severity,
care
exposures that are associated with disease states
SLIDE 6 WHY ARE POPULATION STUDIES IMPORTANT?
- Increases our knowledge
- f the disease in real-life
- Allows for understanding
- f diseases over time
- Monitor the quality of
care (quality improvement)
SLIDE 7
REGISTRIES AND BIOBANKS: WHAT’S THE DIFFERENCE? Registry: Information Biobank: Patient samples (blood, urine, tissue)
SLIDE 8
REGISTRIES AND BIOBANKS: WHAT’S THE COMMONALITY? Both allow for storage of information over time
SLIDE 9 Registry: Information
- Patients choose to be part of a
registry and have data collected
- n:
- Initial diagnosis features
- Labs or imaging findings
- Medications
- Surgeries or tests performed
- Lifestyle
- Family history
SLIDE 10 Biobank: Patient samples (blood, urine, tissue)
samples.
- De-identified samples are
kept in secured laboratories in large freezers
data
SLIDE 11 TYPES OF RESEARCH IN RHEUMATOLOGY
BASIC SCIENCE CLINICAL POPULATION TRANSLATIONAL QUALITATIVE
Animal studies Disease mechanisms Clinical trials New intervention Epidemiology Large databases Associations/trends Basic Science ↔ Clinical Care Experiential data Patient-reported outcomes Survey data
SLIDE 12 WHAT IS A CLINICAL TRIAL?
- A research study that prospectively
evaluates the effects and value of intervention in human participants
- A source of valuable information
which contributes to advancement
- f medicine
- Generate necessary data for
determining whether a new medication is safe and effective by the Food and Drug Administration (FDA)
SLIDE 13
CLINICAL TRIAL PHASES
Phase IV Obtain additional information
after approval of the drug
Phase III Assess clinical effectiveness and
adverse effects of the drug
Phase II
Evaluate the effect of the drug in several different doses
Phase I
Estimate tolerability and characterize properties of a drug
SLIDE 14
BENEFITS AND RISKS OF CLINICAL TRIALS
Benefits Risks ❖ Play an active role in your own health care ❖ Gain access to new research treatments before they are widely available ❖ Obtain expert medical care at leading health care facilities during the trial ❖ Help others by contributing to medical research ❖ Unpleasant or serious side effects to experimental treatment ❖ Experimental treatment may not be effective for you ❖ Some protocols can be time intensive (trips to the study site, more treatments, hospital stays or complex dosage requirements)
SLIDE 15 CLINICAL TRIAL PROCESS
The eligibility of a participant is determined by inclusion and exclusion criteria An informed consent form is reviewed and signed, which describes all the details of clinical trial Participants are asked to visit the clinic according to the protocol and work closely with the research team Participants are closely monitored during the study period and report any new symptoms
SLIDE 16
TARGETED ANT NTI-RHEUMATIC THERAPIES
SLIDE 17 HOW TO GET INFORMATION ON PARTICIPATING IN RESEARCH
- clinicaltrials.gov
- Website of major medical centers
- rheumatology.uw.edu/research/clinical-trials
- Arthritis Foundation
SLIDE 18
TO LEARN MORE ABOUT THE UW DIVISION OF RHEUMATOLOGY’S COMMITMENT TO RESEARCH, PATIENT CARE AND EDUCATION VISIT OUR WEBSITE AT WWW.RHEUMATOLOGY.UW.EDU THANK YOU!
