This document discusses clinical research and provides information on various topics related to conducting clinical research. It covers the aims and objectives of clinical research, basic research methodology, pre-test and post-test probability. It defines research and provides details on developing aims and objectives of clinical research that are specific, measurable, attainable, realistic and time-bound. The document outlines the steps involved in a research process including planning, literature review, developing hypotheses, research design, sampling and data collection. It also discusses estimating pre-test and post-test probability and choosing diagnostic tests based on these probabilities.

1. CLINICAL RESEARCH
• Dr Bipul Borthakur (Professor)
• Dept of Orthopaedics, SMCH

2. TOPICS TO BE COVERED
Aims and objectives of clinical
research
Basic research methodology
Pre test probability
Post test probability

3. RESEARCH
• Research is a quest for knowledge through
diligent search or investigation or
experimentation aimed at the discovery
and interpretation of new knowledge (WHO
2001).

4. AIMS OF CLINICAL RESEARCH
•Aims are broad statements of
desired outcomes that is it
specifies the overall purpose of the
study.

5. OBJECTIVES OF CLINICAL RESEARCH
• Objectives are defined as planned end
point of all activities.
• It is precise.
• It is stated that objectives should be
SMART .

6. S M A R T
• S : Specific
• M : Measurable
• A : Attainable
• R : Realistic
• T : Time bound

7. GOOD VS BAD OBJECTIVES
• Objective is written with an action verb that
is to find out, to assess, to determine etc.

8. STEPS OF A RESEARCH PROCESS
• (A) Planning and defining a research
problem.
• (B) Review of literature.
• (C) Development of working
hypothesis/research question.
• (D) Preparing the research design.

9. STEPS OF A RESEARCH PROCESS
• (E) Estimation of sample size ans sampling
technique.
• (F) Data collection.

10. PLANNING AND DEFINING RESEARCH
PROBLEM
• Find out the problem or areas to be
explored.
• Assessment of practical feasibility in
existing settings is done.

11. REVIEW OF LITERATURE
• Extensive review of concepts and theories
related to the research topic is done.
• First step to understand the current
available information on the research
problem.

12. DEVELOPMENT OF WORKING
HYPOTHESIS
• Hypothesis is a carefully constructed
statement about a phenomenon in the
population; when tested will lead to the
identification of the most likely causes of
disease or changes in the condition being
observed.
• It should be precise and very specific.

13. PREPARING THE RESEARCH DESIGN
Design depends upon factors like :
• Competence of research team
• Man-power
• Money
• Time etc.

14. ESTIMATION OF SAMPLE SIZE ANS
SAMPLING TECHNIQUE
• Sample size is the number of subjects
required to conduct a study.
• It is done by SAMPLING TECHNIQUE so
that so that the sample population
becomes a true representation of the whole
population.

15. DATA COLLECTION
• Primary data : Collected by researcher
himself.
• Secondary data : Collected by someone
else.

17. PRE-TEST PROBABILITY
• The probability of presence of a disease in
a person before doing a diagnostic test.

18. POST TEST PROBABILITY
• The probability of presence of a disease in
a person after doing a diagnostic test.

19. HOW TO ESTIMATE PRE-TEST
PROBABILITY
• Direct studies of disease probability by
doing prevalence studies in a population.
• Clinical experience and judgement.
• Validated clinical prediction rules.
(Example : Duke and diamond forrester
rule)

21. THOUGHTFULLY CHOOSING A
DIAGNOSTIC TEST
• Think about pre test probability
• Whether you want to rule in or rule out a
disease.

23. • COMPARE THE CHARACTERISTICS
OF A TEST BEFORE ORDERING
• To rule in a disease : Test must have high
specificity
• To rule out a disease : Test must have high
sensitivity

24. THANK YOU
“na karmaṇāmanārambhānnaiṣkarmyaṃ puruṣo’śnute
na ca saṃnyasanādeva siddhiṃ samadhigacchati”
“No man can attain freedom from activity by refraining from
action; nor can he reach perfection by merely refusing to
act.”