Quick Start: How to Get a Clinical Research Project Started at UT-Houston Medical School. Kathleen A. Kennedy, MD, MPH Jon E. Tyson, MD, MPH Robert E. Lasky, PhD.
Kathleen A. Kennedy, MD, MPH
Jon E. Tyson, MD, MPH
Robert E. Lasky, PhD
Detailed Literature Review
Detailed Study Protocol
Funding (if needed)
Approval from Physicians, IRB, Hospital
(Jump ahead or return to “Components
of Clinical Research Proposal”)
Richardson WS et al. The well built clinical question: a key to evidence-based decisions.
ACP Journal Club. 1995; 123(3):A12-3.
CRCA Lectures: 11/7/07 (Interventional Studies); 9/3/03 (Observational Studies)
Hulley textbook, Chapter 2 (Question)
Hulley textbook, Chapters 10 & 11, (Clinical Trials)
Friedman LM et al. Fundamentals of Clinical Trials, 3rd ed, Springer,1998.
Jadad A. Randomized Controlled Trials: A User’s Guide, BMJ Books, 1998.
CRCA Lectures: 11/28/07, 12/5/07, 12/12/07 (from Clinical Trial Design Course)
* A cohort study assembles subjects on the basis of eligibility criteria and
the presence or absence of exposure status; subjects are then evaluated,
usually prospectively, for the presence or absence of the outcome of interest. A
clinical trial is a cohort study in which the investigator, usually by random
assignment, determines the exposure or treatment status of the subjects.
Fletcher textbook, Chapter 3 (Diagnosis)
Hulley textbook, Chapter 12 (Medical Tests)
Users’ Guides to the Medical Literature IIIA&B. Diagnostic Tests. JAMA 271:389-391, 703-707, 1994; XVII Screening. JAMA 281:2029-2034, 1999.
CRCA Lectures: 10/17/07 (Diagnosis), 10/24/07 (Screening)
Study of Diagnosis/Diagnostic Test
Study of Diagnosis/Diagnostic Test
Design Features (cont)
Fletcher textbook, Chapter 11 (Cause)
Hulley textbook, Chapters 7 (Cohort Studies), 9(Cross-sectional and Case-Control Studies), and 9 (Causal Inference)
Users’ Guides to the Medical Literature IV. Harm. JAMA 271:1615-1619, 1994.
CRCA Lectures: 9/12/07 (Prospective studies); 9/19/07 (Case-control studies)
* A case-control study assembles subjects on the basis of the presence or
absence of the outcome of interest; subjects are then evaluated, usually
retrospectively, for the presence or absence of the an exposure or exposures.
A cross-sectional study evaluates subjects at a single time point for exposure
and outcome status.
Fletcher textbook, Chapters 5 (Risk) and 6 (Prognosis)
Hulley textbook, Chapter 7 (Cohort Studies)
Users’ Guides to the Medical Literature V. Prognosis. JAMA 272:234-237, 1994.
CRCA Lectures: 9/26/07 (Causation); 10/3/07 (Risk and Prognosis)
Fletcher textbook, Chapter 4 (Frequency)
CRCA Lecture: 9/5/07
Hulley textbook, Chapter 13 (Secondary Studies and Systematic Reviews)
Users’ Guides to the Medical Literature VI. Overviews. JAMA 272:1367-1371, 1994.
CRCA Lectures: 1/16/08
Drummond MF et al. Methods for the Economic Evaluation of Health Care Programmes,
2nd Ed, Oxford, 1997.
Users’ Guides to the Medical Literature XIIIA. Economic Analysis. JAMA 277:1552-1557,
1997; XIIIB. Economic Analysis. JAMA 277:1802-1806, 1997.
CRCA Lectures: 2/13/02 (Quality of Life); 2/20/02 (Economic Evaluations)
Hulley textbook, Chapters 1 (Getting Started) and 3 (Study Subjects)
Moher D et al. The CONSORT Statement: Revised Recommendation for Improving the
Quality of Reports of Parallel-Group Randomized Trials. JAMA 285:1987-1991, 2001.
Schultz KF et al. Empirical evidence of bias. JAMA 273:408-412, 1995.
CRCA Lectures: 1/30/02 (Practical Aspects); 2/6/02 (Data Management)
Fletcher Textbook, Chapter 2 (Abnormality)
Hulley textbook, Chapters 4 (Measurements), 5 & 6, (Sample Size and Power)
CRCA lectures: 10/10/07 (Measurement); 9/6/06-10/4/06 (Biostatistics for
Clinical Investigators Course).
Hulley textbook, Chapter 14 (Ethical Issues)
CRCA Lectures: 2/21/07-4/4/07 (Ethical Issues in Clinical Research Course)
Hulley textbook, Chapter 17 (Implementing Study)
Hulley textbook, Chapter 16 (Data Management)
Hulley textbook, Chapter 15 (Questionnaires and Data Instruments)
Online module on use of Excel: CRCA Computer Course
Online module on use of Access: CRCA Computer Course