Research Methods Tutorial

8/2/2019 Research Methods Tutorial

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Research Methods, Overview

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There are hundreds of Scientific fields and disciplines, ranging from the

Physical Sciences, to the Life Sciences, to the Social Sciences.

The fundamental governing principal they all share in common, that

distinguishes a science as a science is whats referred to as The

Scientific Method.

The Scientific Method can be described as a sequence of steps for

systematically analyzing scientific questions; designing and executingresearch to answer those questions, and producing reproducible

results. The method is expressed in the scientific research that

constantly adds new knowledge and discoveries to the various realms

and endeavors of the sciences.


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Research Methods, Overview

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The Scientific Method can be described as a sequence of steps for

systematically analyzing scientific questions. Examples of steps in this

process are;

Researching previous studies and current data to pose a

question or hypothesis for current research.

Designing a research protocol to answer the question, or

prove/disprove the hypothesis.

Executing the research to create reproducible results.

The scientific method is constantly applied to research, building on

previous studies to add new knowledge and discoveries to theincredible size and diversity of scientific fields.


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Research Methods>Biomedical Application

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For example, lets glimpse into the research methods used to create a

medical treatment.


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Modern Biomedical Science utilizes a long evolved array of

sophisticated methods, technologies, previous research, and

regulatory oversight to create new treatments.


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The Research Methods utilized to create a treatment include Analytical

Methods, Experimental Protocols, and Information/Data research and

processing.

The sophisticated array of analytical methods currently used by

Biomedical Researchers usually derive from the biology and chemistry

of living organisms, enhanced by technology from other sciences such

as computer science, robotics, optics and engineering. Some

examples;

Polymerized Chain Reaction, (PCR) uses enzymes originally isolated from hot springs

bacteria to make quick, cheap copies of DNA. The copied DNA can than be analyzed for

mutations, or to identify the organism from which the DNA was sampled.

High Pressure Liquid Chromatography, (HPLC) uses computer controlled pumps to drive

samples of biological substances through small columns packed with permeable resin

that separate out individual components of the samples based on characteristics such

as different electrical charges, molecular sizes, or other individual characteristics of the

components.


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Experimental Protocols can broadly be separated into Basic and

Applied Research.

Basic research is usually defines as research designed to answer

broad questions or as discovery research performed without the goalof direct applicable or commercial value.

Applied Research is usually performed to create applicable products

(such as medical treatments) from the theories, hypothesis, anddiscoveries derived from basic research.


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A research program can be organized around a particular disease.

This program can be made up of basic research (hopefully) leading to

a number of applied research studies.

These studies utilize documented research procedures referred to as

protocols.

If the research program advances far enough beyond the basic and

initial stages of applied research that it successfully produces a

therapeutic agent showing promise for treating a disease, the

researchers must next apply to a regulatory agency for the approval of

a research protocol to test the therapeutic on human subjects.

This phase of research is called Clinical Trials and the research

protocols, Clinical Trials research protocols.


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Basic and applied research in a program intended to

produce a therapeutic for clinical trials testing is called

Pre-Clinical research.

The program researchers will create a portfolio of all the

various analytical results, previous research, scientifictheory and the protocols they will use to test the

therapeutic on humans. This portfolio is presented to a

regulatory agency (i.e. the FDA or the EMEA).

The agency will carefully evaluate all the data and plans,

perhaps ask for more data or testing and/or approve or

deny the request for a clinical trial.


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If approved, the research enters

the Clinical Trials phase.

This set of protocols is greatly

expanded in complexity,

technology and expertise,especially since human patients

are now the laboratory. Clinical

trials are performed in three

phases, each expanded in size

and complexity. Only a very small

number of therapeutics actuallymake it through the complex,

expensive process from basic

research through clinical trials tobecome an approved therapeutic.

The Source of the Images in this presentation was Creative Commons.


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Research Methods>Biomedical Application>Information

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And last but not least;

The third aspect of this process mentioned back in slide 5 is

Information/Data research and processing.

Modern Biomedical research, (indeed virtually all modern

research) requires utilization of a sophisticated variety ofinformation and data processing.


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Basic and Applied research requires review and evaluation of

information such as journal articles and sources documenting

concurrent and previous research, cumulative information from

databases, epidemiological data, procedures from technical manualsfor experimental methods, and information from other sources.

Other areas of information required for research can include;

Statutory regulations, information from regulatory agencies,

copyright information,

patient records and other patient data,

global decision making data such as strategic intelligence,

economic data, environmental data.

Different types of information are needed throughout this process.

Afterwards, information about an approved pharmaceutical such

pharmacovigilance and epidemiological data will be gathered and

evaluated for as long as the pharmaceutical is utilized in humans.


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Concurrently with information inputs to the research/development

process are information outputs i.e. the data, information,

evaluation, publications, and regulatory filings that are the product ofresearch.

The data produced from modern biomedical research, especiallyclinical/post clinical studies, is huge, complex, and requires

sophisticated indexing, storage and retrieval methodologies to make

it available for evaluation, regulatory requirements and oversight, thisis, of course, a highly regulated requirement for patient testing.

This data is, by necessity, virtually all digital due to requirements forquick access, searcheability, cost-effectiveness, and interoperability

with other data. The volume and sophistication of biomedical data as

well as data interoperability, archiving, retrieval, migration, and the

creation of metadata and information architecture tools that makesthis all possible will only continue to increase over time.


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The Source of the Images in this presentation was CreativeCommons.

Jim. Schroeder. Version 2 040710.

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Research Methods Tutorial