Download MBBS General Surgery PPT 10 Principles And Steps Clinical Research Lecture Notes

PRINCIPLES AND STEPS-

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CLINICAL RESEARCH

RESEARCH

SYSTEMATIC INVESTIGATION TO ESTABLISH

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FACTS

IMPORTANT TOOL TO HELP DEVELOP SOLUTION

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TO BENEFIT PEOPLE ALL OVER THE WORLD
IDENTIFICATION OF BETTER WAYS TO

PREVENT,DIAGNOSE,TREAT AND UNDERSTAND

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HUMAN DISEASES

TREATMENT? CARE PROVIDED TO IMPROVE A

SITUATION OR DISEASE

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CLINICAL TRIAL

RESEARCH STUDY THAT TESTS HOW WELL AN

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INTERVENTION WORKS IN A GROUP OF PEOPLE

TESTS NEW METHODS OF

SCREENING,PREVENTTION DIAGNOSIS OR

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THERAPY
CONDUCTED IN PHASES

ANSWERS SCIENTIFIC QUESTIONS

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ETHICAL

ELEMENTS AND PRINCIPLES

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PROTOCOL
PROTOCOL REVIEW
SPONSORS
ELIGIBILITY CRITERIA
INFORMED CONSENT

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TYPES OF CLINICAL TRIALS
PHASES OF CLINICAL TRIALS
WHO CAN PARTICIPATE IN CLINICAL TRIALS ?

INCLUSION AND EXCLUSION CRITERIA

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IMPORTANCE OF ETHICS IN CLINICAL TRIALS

PROTOCOL

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PLAN OR ACTION PLAN
WHO IS ELIGIBLE
DETAILS ABOUT TEST,PROCEDURES
LENGTH OF STUDY
WHAT INFORMATION WILL BE GATHERED

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LED BY PRINCIPAL INVESTIGATOR
PROTOCOL REVIEW

APPROVAL BY INSTITUITIONAL REVIEW BOARD

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OR IRB,ETHICAL COMMITTEE

SURGEONS,STATISTICIANS,OTHER MEMBERS

ENSURES ETHICS AND RIGHTS OF ALL

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PARTICIPANTS

SPONSOR

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FOUNDATIONS
MEDICAL INSTITUIIONS
SURGEON
VOLUNTARY GROUPS
PHARMA COMPANIES

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OTHER FEDERAL AGENCIES
ELIGIBILITY CRITERIA

GUIDELINES WHO CAN OR CAN'T PARTICIPATE
CHARACTERISTICS THAT MUST BE MINIMALLY

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SHARED BY ALL PARTICIPANTS

AGE
GENDER

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MEDICAL HISTORY
CURRENT HEALTH STATUS,LAB VALUES

INFORMED CONSENT

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PROCESS OF PROVIDING POTENTIAL

PARTICIPANTS WITH IMPORTANT FACTS ABOUT

A CLINICAL TRIAL BEFORE THEY DECIDE TO

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PARTICIPATE

NOT A CONTRACT OR PIECE OF PAPER

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PROCESS
IN PARTICIPANTS NATIVE LANGUAGE

AT AN APPROPRIATE EDUCATIONAL LEVEL

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RESEARCH TEAM PROVIDES AN INFORMED

CONSENT DOCUMENT THAT INCLUDES DETAILS

LIKE

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PURPOSE OF STUDY
DURATION
REQUIRED PROCEDURE
EXPLANATION OF RISK,BENEFIT

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WHO TO CONTACT
PARTCIPANT DECIDES WHETHER TO SIGN OR

NOT

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AFTER SIGNING,NOT BOUND

IF UNCOMFORTABLE AT ANY POINT,CAN

WITHDRAW

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TYPES OF CLINICAL TRIALS

TREATMENT--NEW APPROCH TO SURGERY
PREVENTION

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DIAGNOSTIC
SCREENING
QUALITY OF LIFE--EXPLORE WAYS TO IMPROVE

COMFORT AND QOL WITH CHRONIC ILLNESS

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WHAT HAPPENS IN A TRIAL?

CLINICAL TRIAL COMPARE A NEW MANAGEMENT

STRATEGY OR SURGICAL TECHNIQUE WITH

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ANOTHER THAT ALREADY EXISTS.

THIS DETERMINES IF NEW ONE IS AS SUCCESSFUL

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OR BETTER THAN EXISTING ONE.

RANDOMIZATION IS DONE WHEN TWO OR

MORE ALTERNATIVE TREATMENTS ARE

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ASSIGNED TO VOLUNTEERS BY CHANCE INSTEAD

OF CHOICE.

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SINGLE BLIND

DOUBLE BLIND STUDY
WHO CAN PARTICIPATE?

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INCLUSION CRITERIA? FACTORS THAT ALLOW

TO PARTICIPATE.

EXCLUSION CRITERIA--- FACTORS THAT DO NOT

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ALLOW PARTICIPATION

AGE
GENDER

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TYPE AND STAGE OF DISEASE
SPECIFIC LAB VALUES
OTHER MEDICAL CONDITIONS
NOT PERSONAL

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IDENTIFY APPROPRIATE PARTICIPANTS

KEEP THEM SAFE

APPROPRIATE ANSWER TO

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QUESTION/HYPOTHESIS

ETHICS

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RESPECT FOR PERSONS

BENEFICENCE--TO DO GOOD,TO DO NO HARM

JUSTICE OR FAIRNESS

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RESPECT

RIGHT TO MAKE THEM OWN CHOICES
FACTS PRESENTED PROPERLY
NO PRESSURE

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COMMUNITY RESPECTED
CAB--COMMUNITY ADVISORY BOARD

BENEFICENCE

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RESEARCH SHOULD NOT HARM PARTICIPANTS

LOW RISK

MORE BENEFITS

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JUSTICE

FAIRLY RECRUITED AS RESEARCH PARTICIPANTS

NO FAVOUR TO PARTICULAR,ALL EQUAL

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WHO IS RESPONSIBLE?

ETHICAL COMMITTEE OR INSTITUITIONAL

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REVIEW BODY

REVIEW PROTOCOL
ASK TO CHANGE PROTOCOL WHEN NEEDED
SUPERVISE- BEGINNING TO END

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OVERSEE SCIENTIFIC DESIGN
REVIEW COMMUNITY INTEREST
ENFORCE INFORMED CONSENT

ENFORCE CONFIDENTIALITY

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ETHICAL COMMITTEE

MEMBERS WITH SCIENCE BACKGROUND
MEMBERS WITHOUT SCIENCE BACKGROUND

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RELIGION OR COMMUNITY LEADERS
PEOPLE WHO PARTICIPATED EARLIER
CLEAR UNDERSTANDING WHEN TO TAKE

SECOND OPINION

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FORMULATE HYPOTHESIS