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

Download MBBS (Bachelor of Medicine, Bachelor of Surgery) General Surgery PPT 10 Principles And Steps Clinical Research Lecture Notes

PRINCIPLES AND STEPS-

CLINICAL RESEARCH

RESEARCH

SYSTEMATIC INVESTIGATION TO ESTABLISH

FACTS

IMPORTANT TOOL TO HELP DEVELOP SOLUTION

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

PREVENT,DIAGNOSE,TREAT AND UNDERSTAND

HUMAN DISEASES

TREATMENT? CARE PROVIDED TO IMPROVE A

SITUATION OR DISEASE

CLINICAL TRIAL

RESEARCH STUDY THAT TESTS HOW WELL AN

INTERVENTION WORKS IN A GROUP OF PEOPLE

TESTS NEW METHODS OF

SCREENING,PREVENTTION DIAGNOSIS OR

THERAPY
CONDUCTED IN PHASES

ANSWERS SCIENTIFIC QUESTIONS

ETHICAL

ELEMENTS AND PRINCIPLES

PROTOCOL
PROTOCOL REVIEW
SPONSORS
ELIGIBILITY CRITERIA
INFORMED CONSENT
TYPES OF CLINICAL TRIALS
PHASES OF CLINICAL TRIALS
WHO CAN PARTICIPATE IN CLINICAL TRIALS ?

INCLUSION AND EXCLUSION CRITERIA

IMPORTANCE OF ETHICS IN CLINICAL TRIALS

PROTOCOL

PLAN OR ACTION PLAN
WHO IS ELIGIBLE
DETAILS ABOUT TEST,PROCEDURES
LENGTH OF STUDY
WHAT INFORMATION WILL BE GATHERED
LED BY PRINCIPAL INVESTIGATOR
PROTOCOL REVIEW

APPROVAL BY INSTITUITIONAL REVIEW BOARD

OR IRB,ETHICAL COMMITTEE

SURGEONS,STATISTICIANS,OTHER MEMBERS

ENSURES ETHICS AND RIGHTS OF ALL

PARTICIPANTS

SPONSOR

FOUNDATIONS
MEDICAL INSTITUIIONS
SURGEON
VOLUNTARY GROUPS
PHARMA COMPANIES
OTHER FEDERAL AGENCIES
ELIGIBILITY CRITERIA

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

SHARED BY ALL PARTICIPANTS

AGE
GENDER
MEDICAL HISTORY
CURRENT HEALTH STATUS,LAB VALUES

INFORMED CONSENT

PROCESS OF PROVIDING POTENTIAL

PARTICIPANTS WITH IMPORTANT FACTS ABOUT

A CLINICAL TRIAL BEFORE THEY DECIDE TO

PARTICIPATE

NOT A CONTRACT OR PIECE OF PAPER

PROCESS
IN PARTICIPANTS NATIVE LANGUAGE

AT AN APPROPRIATE EDUCATIONAL LEVEL

RESEARCH TEAM PROVIDES AN INFORMED

CONSENT DOCUMENT THAT INCLUDES DETAILS

LIKE

PURPOSE OF STUDY
DURATION
REQUIRED PROCEDURE
EXPLANATION OF RISK,BENEFIT
WHO TO CONTACT
PARTCIPANT DECIDES WHETHER TO SIGN OR

NOT

AFTER SIGNING,NOT BOUND

IF UNCOMFORTABLE AT ANY POINT,CAN

WITHDRAW

TYPES OF CLINICAL TRIALS

TREATMENT--NEW APPROCH TO SURGERY
PREVENTION
DIAGNOSTIC
SCREENING
QUALITY OF LIFE--EXPLORE WAYS TO IMPROVE

COMFORT AND QOL WITH CHRONIC ILLNESS
WHAT HAPPENS IN A TRIAL?

CLINICAL TRIAL COMPARE A NEW MANAGEMENT

STRATEGY OR SURGICAL TECHNIQUE WITH

ANOTHER THAT ALREADY EXISTS.

THIS DETERMINES IF NEW ONE IS AS SUCCESSFUL

OR BETTER THAN EXISTING ONE.

RANDOMIZATION IS DONE WHEN TWO OR

MORE ALTERNATIVE TREATMENTS ARE

ASSIGNED TO VOLUNTEERS BY CHANCE INSTEAD

OF CHOICE.

SINGLE BLIND

DOUBLE BLIND STUDY
WHO CAN PARTICIPATE?

INCLUSION CRITERIA? FACTORS THAT ALLOW

TO PARTICIPATE.

EXCLUSION CRITERIA--- FACTORS THAT DO NOT

ALLOW PARTICIPATION

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

IDENTIFY APPROPRIATE PARTICIPANTS

KEEP THEM SAFE

APPROPRIATE ANSWER TO

QUESTION/HYPOTHESIS

ETHICS

RESPECT FOR PERSONS

BENEFICENCE--TO DO GOOD,TO DO NO HARM

JUSTICE OR FAIRNESS
RESPECT

RIGHT TO MAKE THEM OWN CHOICES
FACTS PRESENTED PROPERLY
NO PRESSURE
COMMUNITY RESPECTED
CAB--COMMUNITY ADVISORY BOARD

BENEFICENCE

RESEARCH SHOULD NOT HARM PARTICIPANTS

LOW RISK

MORE BENEFITS
JUSTICE

FAIRLY RECRUITED AS RESEARCH PARTICIPANTS

NO FAVOUR TO PARTICULAR,ALL EQUAL

WHO IS RESPONSIBLE?

ETHICAL COMMITTEE OR INSTITUITIONAL

REVIEW BODY

REVIEW PROTOCOL
ASK TO CHANGE PROTOCOL WHEN NEEDED
SUPERVISE- BEGINNING TO END
OVERSEE SCIENTIFIC DESIGN
REVIEW COMMUNITY INTEREST
ENFORCE INFORMED CONSENT

ENFORCE CONFIDENTIALITY

ETHICAL COMMITTEE

MEMBERS WITH SCIENCE BACKGROUND
MEMBERS WITHOUT SCIENCE BACKGROUND
RELIGION OR COMMUNITY LEADERS
PEOPLE WHO PARTICIPATED EARLIER
CLEAR UNDERSTANDING WHEN TO TAKE

SECOND OPINION

FORMULATE HYPOTHESIS