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?

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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 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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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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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!

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