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What Do Biostatisticians Do in Biomedical Research? . 生物統計學家在生物醫學研究中之角色. 張啟仁教授 C. J. Chang, Ph.D. 台大醫學院臨床醫學研究所 台大醫院醫學研究部 11/13/2000. A field of study concerned with the methods of obtaining, summarizing, and drawing inferences from data derived from groups of individuals.

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slide1

What Do Biostatisticians Do inBiomedical Research?

生物統計學家在生物醫學研究中之角色

張啟仁教授

C. J. Chang, Ph.D.

台大醫學院臨床醫學研究所

台大醫院醫學研究部

11/13/2000

slide2

A field of study concerned with the methods

of obtaining, summarizing, and drawing

inferences from data derived from groups

of individuals

Robert Woolson (1987)

What is Statistics?

A set of numbers or quantitative facts

summarized in the form of charts, tables,

and graphs

slide3

Biomedical Research

Basic Science Research 基礎醫學研究

Lab Studies, Animal Studies, Bench Work

 Clinical Medicine Research 臨床醫學研究

Disease Studies, Experimental Studies,

Interventional Studies, Clinical Epidemiology

 Clinical Trials Studies臨床試驗研究

Drug Studies, Pre-Clinical, Phase I, II, III, IV

 Other Related Studies

Public Health, Health Psychology,

Behavior Science, Health Economics,

Health Insurance, Bioethics, etc.

slide4

What is BioStatistics?

Statistics Applied to Biomedical Data

 Method

 Technique

 Science

 Strategy

slide5

What is BioStatistics?

Mathematics

others

Medicine

Basic

Clinical

Biostatistics

Statistics

Collaborative Science

slide6

inference

inference

Truth in the

Universe

Truth in the

Study

Findings

in the Study

Physiology of Research

Investigator’s View:

External

Validity

Internal

Validity

Hulley & Cummings: Designing Clinical Research

slide7

Research

Question

Study

Plan

Actual

Study

design

implement

Physiology of Research

Biostatistician’s + Investigator’s View:

Internal

Validity

External

Validity

slide8

inference

inference

Truth in the

Universe

Truth in the

Study

Findings

in the Study

Research

Question

Study

Plan

Actual

Study

design

implement

Physiology of Research

How Does it Work?

External

Validity

Internal

Validity

Hulley & Cummings: Designing Clinical Research

slide9

Collaborating Team Work

Principal Investigator

Biostatistician

Lab Scientist

Project Director

Research Nurse

Data Programmer

etc.

slide10

??!!

Question from Biostatistician?

Is the Study

Feasible?

Reasonable?

Acceptable?

Doable?

slide11

What Do Biostatisticians Do?

Before Designing the Study:

 Pilot Study

 Primary Hypothesis

 Analysis Plan

 Choice of Variables

 Experimental Design

slide12

N=2987?!

What Do Biostatisticians Do?

Before Designing the Study:

 Sample Size Calculation

 Power Analysis

slide13

What Do Biostatisticians Do?

During the Study:

 TEAM work

 Questionnaire Design

 Data Base Management

 Quality Assurance/Quality Control

 Monthly, Semi Annual, Annual Reports

 Interim Data Analysis

 etc...

slide14

What Do Biostatisticians Do?

At the End of the Study:

Tips in Statistical analysis

 Always start with descriptive statistics

 Scatter plot

 Use of appropriate variable

 Use simple, efficient, and practical methods

 Time independent vs. time dependent covariates

 Not necessary advanced methods

 Use most popular, acceptable statistical packages

 Use universal recognizable data format

slide15

What Do Biostatisticians Do?

Making Conclusions and Interpretation

 How to control type-I, II errors

 One answer for one hypothesis

 Statistical vs. clinical significance

 Over powered vs. under powered

 Multiple comparisons

 Over stretch statistical method

slide16

Example: KSBPS

Kidney Stone - Blood Pressure Study

A study of the effects of Extracoporeal Shock Wave

Lithotripsy (ESWL) on Hypertension

腎結石病人使用電動碎石機後與高血壓相關性之研究

PI : Michael Alderman, M.D.

Co-PI : Chee Jen Chang, Ph.D.

Co-PI : Jonathan Tobin, Ph.D.

Albert Einstein College of Medicine

Funded by National Electronic Manufacture Association

(NEMA) and approved by FDA in 1990

slide17

KSBPS

Kidney Stone - Blood Pressure Study

Original Protocol:

Prospective two year follow up study for 4 years

Post marketing surveillance study

Phase IV study

Experimental study : ESWL vs. open surgery

Non randomized and non musked design study

Multi centers study

slide18

KSBPS

Kidney Stone - Blood Pressure Study

Study Design:

Sample size :

900 control, 900 ESWL patients

Primary variables :

SBP/DBP at baseline, 6, 12, and 24 months

Secondary variables:

Renal functions at 0, 6, 12, and 24 months

Covariates:

Demographic variables, stone burden

slide19

KSBPS

Kidney Stone - Blood Pressure Study

Hypothesis :

DBP difference between control and ESWL groups is not greater 2.5 mmHg at 24 month

slide20

KSBPS

Kidney Stone - Blood Pressure Study

Difficulties:

Patients selection bias

Patient’s follow-up visit interest is LOW

Renal function collection is costly and unchanged

Different device type

Different technology in device type

New technology developed during the study

slide21

KSBPS

Kidney Stone - Blood Pressure Study

Statistical solutions to some difficulties:

Patients selection bias : statistical analysis controlling covariates

Patient’s follow-up visit interest is LOW: reduce sample size, increase effect size

slide22

KSBPS

Kidney Stone - Blood Pressure Study

Statistical solutions to some difficulties:

Renal function collection is costlyand unchanged:bioequivalence testto revise protocol

Different device type and technologyin device type:stratified data analysis

slide23

KSBPS

Kidney Stone - Blood Pressure Study

Can Statistics solve all the difficulties?

No !

New technology developed duringthe study

Participants’ willingness

slide24

KSBPS

Kidney Stone - Blood Pressure Study

In September, 1997, FDA issues:

“Although an increase in blood pressuremay result after Lithotripsy for the treatmentof kidney stones, a 2 years prospective studysuggests that treatment with Lithotripsy willnot result in a difference in diastolic bloodpressure of  4 mmHg as compared to otherkidney stone therapies.”

slide25

What Do Biostatistician Do?then, now and future

  • Methodology development
  • Consultant
  • Health- and bio- informatics
  • Research protocols review
  • Committee of Clinical Investigation (CCI)
  • Internal Review Board (IRB)
  • Regulatory review
slide26

What Do Biostatistician Do?then, now and future

  • Teaching (university, medical school)
  • Research (institute, foundation)
  • Government Agency (NIH, CDC)
  • Regulatory Agency (FDA)
  • Industry (Pharmaceutical, Biotech.)
  • Consulting (CRO)
slide27

Thank You!

Email: [email protected]

Phone: 02-2312-3456 ext 6588

Fax: 02-2371-0262

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