LECTURE 01 2011

LECTURE 01 2011 - PubH 7- 420 Clinical Trials Instructor:...

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1 PubH 7- 420 Clinical Trials Instructor: Jim Neaton 612-626-9040 jim@ccbr.umn.edu 2221 University Ave SE, Room 200 Text: Fundamentals of Clinical Trials Friedman, Furberg, and DeMets Evaluation: Homework: 4 exercises (25%) Protocol project (25%) Mid Term (25%) Final (25%) Web Site: http://www.biostat.umn.edu/~ph7420
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2 TAs for PubH 7420 Xiting Cao – caoxx060@umn.edu Hours: 9-11 AM on Wednesday Raj Guha Niyogi – guhan003@umn.edu Hours: 9-11 AM on Monday
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3 General Methods of Investigation 1. Chance observations 2. Case histories individual cases case series 3. Uncontrolled trials of an intervention 4. Cross-sectional (naturalistic) studies 5. Case-control studies 6. Prospective follow-up studies 7. Randomized clinical trial No planned concurrent comparison group
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Yes Did Investigator Assign Exposures? Yes Randomised controlled trial Non- randomised controlled trial Yes No No Experimental study Random allocation? Observational study Comparison group? Analytical study No Descriptive study Direction? Cohort study Case- control study Cross- sectional study Exposure Outcome Exposure and outcome at the same time Exposure Outcome Grimes and Schulz, Lancet , 359:57-61, 2002.
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5 Hierarchy of Evidence Coherence of evidence from multiple sources Systematic review of well-designed, large randomized trials Strong evidence from one large randomized trial Systematic review of small trials (e.g., surrogate outcome studies) Systematic review of from well-designed cohort studies Strong evidence from one cohort study Unsystematic observations (expert opinions) Adapted from Devereaux PJ et al, Evidence-Based Cardiology, 2nd Edition,
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6 Rating Schemes for Clinical Guidelines Quality of Evidence (as per previous slide) Strength of Recommendation + A: Strong B: Moderate C: Optional + from DHHS guidelines for the treatment of HIV http://www.aidsinfo.nih.gov/Guidelines
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7 Chance Observations Examples Bleeding among children chewing gum containing aspirin to relieve the pain from tonsillectomies (Dr. Lawrence Craven) Discovery of penicillin (Fleming) and digitalis (purple foxglove) (Withering)
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8 Case Histories 1. Most ancient and widely used method of clinical investigation 2. Most useful for disease with a specific etiologic agent 3. Standard for comparison is usually implicit Weaknesses No concurrent control Usually inadequate information about persons not developing the disease Cases may not be representative; persons with disease are survivors of unknown population
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9 Example: Case Series Jaffe et al. Acquired immune deficiency syndrome in the United States: The first 1,000 cases. J Inf Dis 148:339-45, 1983. Purpose: To describe characteristics of the cases.
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10
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11 Case Definition Eligibility Criteria : 1. Biopsy proven Kaposi sarcoma (KS) or 2. Biopsy, histology, or culture proven infection moderately predictive of cellular immune deficiency a. Protozoal and helminthic infections, e.g., Pneumocystis carinii pneumonia (now Pneumocystis
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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LECTURE 01 2011 - PubH 7- 420 Clinical Trials Instructor:...

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