Research Methods, Overview
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 what’s referred to as “The
Scientific Method”.
The Scientific Method can be described as a sequence of steps for
systematically analyzing scientific questions; designing and executing
research 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
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 the
incredible size and diversity of scientific fields.
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Research Methods>Biomedical Application
For example, lets glimpse into the research methods used to create a
medical treatment.
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Research Methods>Biomedical Application
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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Research Methods>Biomedical Application
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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Research Methods>Biomedical Application
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 goal
of direct applicable or commercial value.
Applied Research is usually performed to create applicable products
(such as medical treatments) from the theories, hypothesis, and
discoveries derived from basic research.
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Research Methods>Biomedical Application
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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Research Methods>Biomedical Application
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, scientific
theory 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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Research Methods>Biomedical Application
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 actually
make it through the complex,
expensive process from basic
research through clinical trials to
become an approved therapeutic.
The Source of the Images in this presentation was Creative Commons.
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Research Methods>Biomedical Application>Information
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 of
information and data processing.
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Research Methods>Biomedical Application>Information
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 manuals
for 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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Research Methods>Biomedical Application>Information
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 of
research.
The data produced from modern biomedical research, especially
clinical/post clinical studies, is huge, complex, and requires
sophisticated “indexing”, storage and retrieval methodologies to make
it available for evaluation, regulatory requirements and oversight, this
is, of course, a highly regulated requirement for patient testing.
This data is, by necessity, virtually all digital due to requirements for
quick 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 makes
this all possible will only continue to increase over time.
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Research Methods>Biomedical Application>Information
The Source of the Images in this presentation was Creative
Commons.
Jim. Schroeder. Version 2 040710.
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