Clinical Researh in Clinics
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Transcript of Clinical Researh in Clinics
Clinical Research in Clinic An overview
Dr. Saurav Arora BHMS (DLI), Gold Medalist
Senior Research Fellow (CCRH) www.audesapere.in
Initiative to Promote Research in Homeopathy
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• Clinical research is different from Clinical practice.
• In clinical practice, we use established treatment(s) while in clinical research we collect evidence to establish treatment(s).
• Should we chase clinical research still???
• And what exactly we mean by clinical research at clinics?
2 ©Dr Saurav Arora
What we aim at? • Research – “Research may be defined in number
of ways; according to our own personal experience also; explore, verify, present”
• Types of Research – Primary & Secondary
– Primary- Fundamental, Clinical & Epidemiological
– Secondary-Meta analysis, reviews, systematic reviews
• Clinical Research – Clinical research is a branch
of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
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Why to limit to Clinical Research
• Aims and Objectives of undertaking Clinical Research
– To a certain extent it is feasible for us to conduct.
– When proper planned it can be carried out with Ease
– May be carried in less finances than fundamental research
– May be conducted at clinical setup under proper guidance
– A great tool to contribute and support our science
– Gives us internal satisfaction and confidence for clinical practice.
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The bifurcation of CR
Experimental
Clinical study
Phase – I
Phase – II
Phase – III
Phase – IV
Observational
Therapy Study
Prognostic Study
Diagnostic Study
Observational Study with drugs
Secondary data analysis
Case Series
Single Case Reports
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Where is Our cup of tea….
Experimental
Clinical study
Phase – I
Phase – II
Phase – III
Phase – IV
Observational
Therapy Study
Prognostic Study
Diagnostic Study
Observational Study with drugs
Secondary data analysis
Case Series
Single Case Reports
Pilot/Exploratory studies
Clinical Verification 6 ©Dr Saurav Arora
What we need ???? • The pre requisite is the aim- to explore and
mission- to support homoeopathy!
• A Logic – Like the one Hahnemann had (Inductive and Deductive)
• Knowledge of some of the basic terms and methods
• A team…
• In order to have what we think is of interest to us, we must be well verse with Scientific Methods!
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A brief about Scientific Methods
• Before proceeding further we must have some idea regarding Scientific Methods
• Scientific methods are nothing new terms; we are using them since eternity.
• Scientific Methods when aptly applied to Research are called Research Methods.
• These include steps like: -
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©Dr Saurav Arora
See…Observe.. And Identify…. • Identification of the area of our interest or where we
have problems.
• We must be “Interested” for this problem. (Be Industrious…..)
• It should be relevant… irrelevant things are not long lasting....No Air Castles
• The problem should be feasible……don’t expect magic to happen!!!.....
Then the problem is converted into a specific question, the “research question”, to which answers are looked for.
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Formulating the research question…. The step 2….
• Remember two golden rules for a perfect research question: -
1. The FINER criteria
– F: - Feasible
– I: - Interesting to undertake
– N:- Novel
– E: - Ethical
– R: - Relevant
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Step 2 continues……
2. And PICOT criteria
– P: Population of Interest
– I: The Intervention being compared
– C: Comparison group
– O: Outcome of interest
– T: Time
In patients of Diabetes whether Szygium jambolanum when compared to placebo has any anti diabetic potential in comparison to patients on placebo after 03 months of treatment?
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The Next step… Know what you are doing….
• Once we have identified and noted down the work to be done, we must search the existing work done on the same question.
• This is called literature search and its aim is to know what already has been done… and what better we can do……
• The common sources include… Books… Journals (peer reviewed preferably)…. Online resources like Pubmed, Medical Matrix, Cohchrane Library, NICE guidelines etc…..
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Step 4: Formulate formally
• Till this step we have been informal in approach as per our wish and will.
• Now is the time to get formal… to apply scientific standards for framing a protocol/proposal….
• We must design: -
– Null hypothesis
– Alternate hypothesis
– Aim and Objective (Primary and secondary)
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©Dr Saurav Arora
Data sources and approach… the Step 5
• Where we are going to undertake the study?
• Who will participate and Why?
• What all thing we need to convince people or to enroll people to our study?
• What we should not include?
• How may people should we take?
These are some of the questions we must answer before proceeding further. We must take help of a bio-statistician for a good sample size.
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Study design and methodology This part seems to be the most difficult part of before the
initiation of the study. Some common study designs-
a)Observational: Studies in which subjects are observed- include
– Case study/case series
– Case-Control
– Cross Sectional
– Cohort/Longitudinal
– Surveys
b) Experimental: Studies in which the effect of an intervention is observed
– Controlled trials
– Diagnostic Test 15 ©Dr Saurav Arora
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Step-7: The real technical challenge Writing the protocol for the study
The protocol should contain
– Background information on the study
– Objectives
– Ethical aspects
– Study design
– Study procedures
– Method of assessment
– Statistics and evaluation
– Administrative issues and
– References
Remember, this is the backbone of the study. Any misfit vertebra will cause Chronic backache.
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Some further steps……
• Each of the following step is a big chapter in itself.
– Collection of data
– Analysis of data with tools and techniques
– Writing the report
– Publishing of results in some good journal.
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So finally what we can do now?
Case Study
Case Series
Pilot/Exploratory Trials
Surveys Cost effectivity/Techniques of
prescription/Epidemiological
data in relation to disease
presentation in homoeopathy
Clinical Verification
For drawing the Prescribing
Precision/Verifying the
symptoms from pool of
materia medica
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What benefits one can get ????
• The process of research is usually a dry one.
• But it can be made adventurous if are willing to do quality research.
• Many a time people ask “what is the benefit of such a long exercise?”
• The answer lies in the contribution, satisfaction and support we intend to give to our science.
• In addition………………………..
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• ??????
• ??????????????
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In addition…. • We get name, fame and experience
• We learn how to work with other like minded people
• We learn to know the intricacies of research methods
• We get boost in case of positive results and insight/motivation in case of negative/neutral results
• We can actually feel the struggle our stalwarts went
through to make homeopathy acceptable.
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How to grab it…..????
• Be Honest!!
• “Just Do it” attitude!
• Make a group…
• Discuss…. Identify….
• Undertake…..
• Collect data…..
• Contact experts!
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Let us summarize in Nut Shell…..
• Clinic is a potential source of genuine data, the only requisite is our dedication and honesty!
• We can under take Pilot/Exploratory Studies at our Clinics
• We can conduct Surveys
• We can report Evidence Based Cases/Case Series for the benefit of Science.
• We can undertake Clinical Verification.
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Last but not the least….
Past is experience, Present is experimentation and future is expectation.
Use your experience in experimentation to achieve your expectations!
25 ©Dr Saurav Arora