Research Methods, Overview

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					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.

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.

Research Methods>Biomedical Application

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

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.

Research Methods>Biomedical Application

   The Research Methods utilized to create a treatment include Analytical
   Methods, Experimental Protocols, and Information/Data research and

  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
     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
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.

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

    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.

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.

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 i n this presentation was Creative Commons.
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.

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.
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
   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.
Research Methods>Biomedical Application>Information

        The Source of the Images in this presentation was Creative

         Jim. Schroeder. Version 2 040710.


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