How to Participate in Research

1
How to Participate in Research

• Eric Kleerup, M.D. Donald Tashkin, M.D.
• David Geffen School of Medicine at UCLA
• Los Angeles, California

2
What is Human Research?

• Human subjects are living individuals about whom
  an investigator conducting research obtains
• Data through intervention or interaction with an
  individual or
• Identifiable private information
• Research is a systematic investigation including
  research development, testing and evaluation
  designed to develop or contribute to
  generalizable knowledge.

3
Why do we perform research?

• To understand the disease process
• To develop treatments for diseases

4
How does a drug get approved for use?

• Preclinical, animal and laboratory studies
• Phase 1 human toxicity
• Phase 2 safety in patients with disease
• Phase 3 efficacy
• Phase 4 other questions
• Comparison to other treatments
• Cost effectiveness
• Marketing issues

5
Informed Consent

• Identification of investigators
• Purpose of the study
• Procedures
• Risks and benefits
• Alternative treatments
• Payments and costs
• Privacy
• Withdrawal from the study
• Subjects rights

6
Informed Consent

• Ask Questions

7
Inclusion and Exclusion Criteria

• Does the subject have the disease being studied?
• Is the subject too sick or too well?
• Is it safe for them to take the drug and have the
  procedures?
• Do they have other diseases that might effect the
  outcome of the study?

8
Flavors of Studies

• Observational or cohort
• Open label
• Placebo controlled
• Single blind or double blind
• Cross-over
• Salvage or rescue
• Quality of life
• Mechanistic

9
How can I be in a research study at UCLA?