department of epidemiology and biostatistics designing clinical research session #1 about this...
TRANSCRIPT
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Department of Epidemiology and Biostatistics
DESIGNING CLINICAL RESEARCH
Session #1
• About this course
• Chapters 1 & 2
• Examples
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Course Objectives
1. Acquire research skills
2. Produce a protocol for a study
3. Help others in the workshop
4. Provide feedback on the workshop
5. Have a multiplier effect
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Course Ingredients
July 29- Lectures (9:00 - 9:50)Sept 9 Selected issues from DCR 3 text
Sections (10:00 - 11:50)Protocol componentsMore issues from the text
Sept 16 5-page protocols due
Oct 7, 14 Protocol review sessions In pairs, new faculty
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Types of Study
• Not the best choice for this course– Mice, molecules without humans– Cost-effectiveness, meta-analysis– Secondary data analysis– Qualitative research
• Ideal– A new observational study or clinical trial
involving humans (+ molecules) that you will do this year
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Computer skills
• You need to know how to– Word process, use Pubmed – Use a reference program such as Endnote
• You can learn by– Getting a mentor or friend to show you– Taking a course in the UCSF Library
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Certificate
• For satisfactory performance in all 3 TICR Summer Workshop courses, including:– Turning in your 5-page protocol on time– Turning in your ethics project on time– Turning in your career plan on time
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Faculty for sections
Christian Apfel MD, PhD AnaesthesiaHeidi Bauer MD, MPH Public HealthValerie Flaherman MD, MPH PediatricsAri Green MD, MAS-CR NeurologyJohn Inadomi MD, MPH GastroenterologySteve Hulley MD, MPH Cardiovascular
EpidemiologyMichael Kohn MD, MPP Emergency MedicineKathleen Liu MD, PhD, MAS-CR Nephrology/Pulm Crit CareChris Madsen MD, MPH PediatricsMark Pletcher MD, MPH General Internal MedicineTravis Porco PhD Mathematical ModelingJoel Simon MD, MPH General Internal Medicine
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Faculty for sections
Christian Apfel MD, PhD Clinical Research MethodsHeidi Bauer MD, MPH Clinical Research MethodsValerie Flaherman MD, MPH Clinical Research MethodsAri Green MD, MAS-CR Clinical Research MethodsJohn Inadomi MD, MPH Clinical Research MethodsSteve Hulley MD, MPH Clinical Research MethodsMichael Kohn MD, MPP Clinical Research MethodsKathleen Liu MD, PhD, MAS-CR Clinical Research MethodsChris Madsen MD, MPH Clinical Research MethodsMark Pletcher MD, MPH Clinical Research MethodsTravis Porco PhD Clinical Research MethodsJoel Simon MD, MPH Clinical Research Methods
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Course Coordinator
Olivia DeLeon
514-8231 (tel)
514-8150 (fax)
(Please let her know if your email address has changed by sending her an email)
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Anatomy of research: What it’s made of
• Research question– Significance
• Design• Subjects
– Population– Sample
• Variables– Predictor– Outcome
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Physiology of research: How it works
Using measurements in a sample
to draw inferences about
phenomena in a population
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QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
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Hulley’s Research Question (1993)
Should postmenopausal women receive hormones?
Subjects: postmenopausal women
Predictor: “hormones”
Outcome: ?
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Improved Research Question
Does estrogen treatment prevent heart attacks in postmenopausal women?
Subjects: postmenopausal women Predictor: estrogen treatment vs none Outcome: heart attacks
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Is RQ FINER?
Feasible
Interesting
Novel
Ethical
Relevant
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Is RQ FINER?
Need to specify the design
of the study
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Designs
• Observational study– Cohort – Cross-sectional– Case control
• Randomized clinical trial– Surrogate endpoints– Endpoints of primary interest
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Cohort design
Subjects– 5000 post-menopausal women living in the
Bay Area
Predictor:– Taking estrogen?
Outcome:– Subsequent 5-year incidence of MI
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Cross-sectional design
Subjects– 2000 PM women seen at SFGH
Predictor:– Taking/took estrogen?
Outcome:– History of MI?
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Case-control design
Subjects– Cases: 50 PM women with MI in the SFGH ED– Controls: 50 PM women with trauma in the SFGH ED
Predictor:– Taking/took post-menopausal estrogen?
Outcome:– Cases vs controls
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Author (year) Relative riskLafferty (1985) 0.2*Sullivan (1990) 0.2*Hammond (1979) 0.3*Nachtigall (1979) 0.3*Stampfer (1991) 0.3*Bush (1987) 0.4*Pettiti (1987) 0.5*Grodstein (1996) 0.6*Henderson (1991) 0.7*Psaty (1994) 0.7Wolf (1991) 0.7*Falkeborn (1992) 0.7*Criqui (1988) 1.0Wilson (1985) 1.9
Combined 0.7*
Observational Studies of Estrogen and CHD
Barrett-Connor, Public Health Reviews, 1997 * p < .05
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NB, when choosing a research question and design
Importance of thorough literature review and scholarship
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Randomized blinded trial design: Surrogate outcomes
Subjects– 60 Post-menopausal women
Predictor:– Randomized to estrogen vs placebo
Outcome 4 weeks later:– LDL-C decreased by 10%, p<.01– HDL-C increased by 10%, p<.01
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Randomized blinded trial design:Disease event outcomes
Subjects– Post-menopausal women
Predictor:– Randomized to estrogen vs placebo
Outcome:– Subsequent incidence of MI
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Feasible?
Clinical trial of estrogen vs placebo to prevent MI/CHD death in 10,000 women with prior hysterectomy
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More feasible
Secondary prevention trial of estrogen + progestin vs placebo to prevent MI/CHD death in 2500 women with a uterus and prior CHD
• Participants willing, available in 20 centers
• Wyeth-Ayerst willing to fund, with UCSF controlling the science
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HERS trial(Heart and Estrogen/progestin Replacement Study)
• Subjects– 2763 women; age < 80 (mean age = 67)– postmenopausal, with a uterus– documented coronary disease
• Predictor– .625 mg Premarin + 2.5 mg MPA (E+P)
vs blinded placebo, randomly assigned
• Outcome – 4-year rate of non-fatal MI and CHD death
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Interesting?
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QuickTime™ and aTIFF decompressor
are needed to see this picture.
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Novel?
First randomized blinded trial with disease endpoints of whether estrogen treatment prevents CHD
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Ethical?
• Equipoise (uncertain whether benefits or harms predominate)
– Benefits of hormone Rx • Reduce menopausal symptoms• ? Prevent CHD• ? Prevent fractures• ? Prevent Alzheimer’s Disease• ? Improve quality of life
– Harms • ?Venous thrombo-embolism• ? Breast cancer
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Relevant?
• Premarin/Prempro: #1 in sales• Decision faced by half the population
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Please notice the changes in research question
Observational RQ:
Is estrogen associated with heart attacks in postmenopausal women?
Intended clinical trial RQ:
Does estrogen prevent CHD events in postmenopausal women?
HERS RQ:
Does estrogen + progestin prevent new CHD events in postmenopausal women with coronary disease?
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HERS findings
All primary CHD events 290 293 .99 .99
Hulley et al JAMA 1998;280:605-13
Treatment GroupTreatment Group
E + PE + P PlaceboPlacebo RHRH p p
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Why the null CHD result?Three possibilities
1. HERS got the wrong answer
2. The observational and other studies got the wrong answer
3. They answered different questions
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1. HERS got the wrong answer
• Random error?
• Systematic error?
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Random error?
All primary CHD events 290 293 .99 .84-1.17
Hulley et al JAMA 1998;280:605-13
Treatment GroupTreatment Group
E + PE + P PlaceboPlacebo 95% CI95% CIRHRH
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HERS got the wrong answer: Systematic error?
• Randomization
• Blinding– Co-intervention– Biased outcome ascertainment
• Adherence to treatment
• Loss to follow-up
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2. The observational studies got the wrong answer
• Random error?
• Systematic error?
• Confounding?
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Confounding
• Big problem in observational studies of drugs for preventive medicine – Women who take hormones are inherently healthier
• Statistical adjustment is only a partial solution– Only a randomized trial can solve the problem
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3. HERS answered a different question
• Other populations more responsive?– Primary prevention earlier in menopause
• Other interventions better benefit/harm ratio?– Estrogen only– Different E, different P– Lower doses
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Three possibilities
Physiology:
1. HERS got the wrong answer
2. The observational studies got the wrong answer
Anatomy:
3. They answered different questions
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How to decide?
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Replication:The primary prevention Women’s Health Initiative
WHI E+P Trial• Subjects:16,608 women with a uterus, mean age 63
• Predictor: E+P vs placebo (as in HERS)
• Outcome: MI + CHD death (as in HERS)
WHI Estrogen-only Trial• Subjects:10,739 women with no uterus, mean age 64
• Predictor: E vs placebo
• Outcome: MI + CHD death
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Disease outcomes in HERS and WHI
Outcome HERS E+P WHI E+P WHI E-alone
MI+CHD death 1.0 (0.8-1.2) 1.3 (1.0-1.6) 0.9 (0.8-1.1)
Stroke 1.2 (0.9-1.7) 1.4 (1.1-1.8) 1.4 (1.1-1.8)
Pulm Embolism 2.1 (1.3-3.4) 2.1 (1.6-2.8) 1.3 (0.9-2.1)
Breast cancer 1.3 (0.8-1.9) 1.3 (1.0-1.6) 0.8 (0.6-1.0)
Hip fracture 1.1 (0.5-2.5) 0.7 (0.5-1.0) 0.6 (0.4-0.9)
Dementia* 2.0 (1.2-3.5) 1.5 (0.8-2.7)
Hulley, JAMA 2004;291:1769 (editorial)
*Schumaker, JAMA 2004;291:2947
RH (95% CI)
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Ethical?
• Equipoise (uncertain whether benefits or harms predominate)
– Benefits of hormone Rx • Reduce menopausal symptoms• ? Prevent CHD• ? Prevent fractures• ? Prevent Alzheimer’s Disease• ? Improve quality of life
– Harms • ?Venous thrombo-embolism• ? Breast cancer
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Bottom lines
• HERS did get the right answer– If properly designed and carried out,
experiments trump observational studies
– Observational studies of drugs are often confounded
• Practice guidelines on hormones after menopause– Do not use for prevention of CHD, dementia
• This applies to any regimen, pending further trials
– Can use for treating menopausal symptoms
• Low dose, short duration
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Source: IMS Health NPA Plus
0
10
20
30
40
50
60
1995 1996 1997 1998 1999 2000 2001 2002 2003Year
An
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Pre
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ns
by
Fo
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lati
on
(m
illi
on
s)
Oral E Oral E/P Trnd/Vag
Annual Number of US Prescriptions for Hormone Therapy
HERSWHI
Hersh, JAMA 2004;291:47
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NB
HERS and WHI were very large studies.
How about something bite-sized?
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The research cycle
Develop research question
Design study
Implement studyAnalyze results
Infer conclusions
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Next …
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One sentence describing anatomy of your study
• Research question• Design• Subjects• Variables
– Predictor– Outcome
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FINER?
Feasible
Interesting
Novel
Ethical
Relevant