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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

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?
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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 Dr Saurav Arora 3 human use.

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

Clinical study

Therapy Study
Prognostic Study Diagnostic Study Observational Study with drugs

Phase I Phase II Phase III

Secondary data analysis Case Series Single Case Reports

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Phase IV

Where is Our cup of tea.

Clinical study

Therapy Study Prognostic Study

Diagnostic Study
Observational Study with drugs Phase I Phase II Secondary data analysis Case Series

Phase III
Phase IV

Single Case Reports

Pilot/Exploratory studies
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Clinical Verification

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: Dr Saurav Arora

SeeObserve.. 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 feasibledont 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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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 designsa)Observational: Studies in which subjects are observedinclude
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
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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 Surveys Clinical Verification
Pilot/Exploratory Trials

Cost effectivity/Techniques of prescription/Epidemiological data in relation to disease presentation in homoeopathy 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!

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