Unit-1

An Introduction to Research: Definition and characteristics of Research, Types

of Research, Criteria of
good research, Research Process, Review of literature and Research gap,
Formulating and defining the research problem. Research methods v/s
methodology. Format for Research Protocol. Research ethics and
importance of Institutional Review Boards. Significance of research in
Pharmaceutical Sciences

Definition of Research
"Research is a systematized effort to gain new knowledge".
RESEARCH IN COMMON REFERS TO SEARCH FOR KNOWLEDGE.
IN OTHER WORDS, IT IS A SCIENTIFIC AND SYSTEMATIC SEARCH FOR
INFORMATION ON SPECIFIC TOPIC.
Characteristics/Features of Good Research
Characteristics of Research
1. Empirical - research is based on direct experience or observation by the
researcher.
2. Logical-research is based on valid procedures and principles.
3. Cyclical -research starts with a problem and ends with a problem.
4. Analytical - research utilizes proven analytical procedures in gathering data,
whether historical, descriptive, experimental, and case study.
5. Critical-research exhibits careful and precise judgment.
6. Methodical - research is conducted in a methodical manner without bias
using systematic method and procedures.
7. Replicability - research design and procedures are repeated to enable the
researcher to arrive at valid and conclusive results.
Quantitative Research
• Quantitative data relies on quantifying a certain amount or quantity of a
specific phenomenon.
• It focuses on gathering and analyzing numerical data and can be used to
find averages and patterns or to predict outcomes.
• Quantitative Research falls within the two primary categories of research
and relies on numbers.
• It draws a conclusion using tables, facts, and graphs. Many scientific and
field-based studies primarily use this form of research.

Qualitative Research
• It refers to the non-numerical elements in the research.
• Qualitative research helps to form a better summary of theories in the
data.
Descriptive Research
• Descriptive research is a type of analysis that outlines the features of the
population or issues under study.
• This descriptive methodology focuses on the “what” of the research
problem more than the “why.”
• The primary methods used in descriptive research include observations,
surveys, and case studies
• Its advantages include a) being effective at analyzing topics and issues
that cannot rely on numbers, b) being observable in an unaltered natural
environment, and c) taking less time than quantitative experiments.

Analytical Research
• Analytical research uses proven facts to form the basis for the research.
Researchers frequently research to find supporting data that strengthens
and authenticates their earlier findings. Also, it helps to develop new
concepts related to the research subject.
• There are various ways to conduct this research, including meta-analysis,
literary or scientific trials, and learning about public opinion.

Applied Research
• Action research that only studies one domain and usually generalizes the
findings is called applied research
• Applied research aims to solve a current issue facing society or a
business/industrial organization.
 • Applied research is considered non-systematic inquiry; a business,
government body, or individual typically conducts this research to
address a particular issue.
Fundamental Research
• The formulation of a theory and generalizations are the primary
concerns of fundamental research.
• It seeks to discover facts with a wide range of applications,
supplementing the ideas already known in a specific field or industry.
• Some examples of fundamental research are research on the
generalization of human behavior or research on pure mathematics.
Exploratory Research
• Theories and their explanation are the basis of Exploratory Research.
• Its goal is only to investigate the study questions, not to provide
definitive and conclusive solutions to current problems.
• The findings are usually a related topic, which helps improve the
research
Conclusive Research
• Conclusive research has a clear design in the methodology and intends
to answer the research question.
• The results of exploratory studies can be validated and quantified using a
conclusive research design.
Primary Research vs. Secondary Research
Surveys
• Surveys play a prominent role in the research method.
• It helps collect a vast amount of real-time data and helps the research
process. It is done at a low cost and is usually faster than any other
method.
• A researcher can conduct surveys in both quantitative and qualitative
methods.
• The researcher usually prefers quantitative surveys over qualitative ones
as they provide numerical outputs and accurate data.
Case Studies
• A common technique for qualitative analysis is the case study method,
which focuses on the in-depth study.
CRITERIA FOR GOOD RESEARCH
• The purpose of the research should be clearly defined and common
concepts be used.
• The research procedure should be defined in sufficient detail.
• The study design should be carefully planned
• The analysis of the data should be sufficient.
• The validity and reliability of the data should be checked carefully.
• Good research is systematic: It means that research is structured with
specified steps to be taken in a specified sequence in accordance with
the well-defined set of rules.
• Good research is logical:
• Good research is empirical: It means that the research is related
basically to one or more aspects of a real situation and deals with
concrete data that provides a basis for external validity to research
results.
• Good research is replicable: This characteristic allows research results to
be verified by replicating the study and thereby building a sound basis
for decisions.
 RESEARCH PROCESS
8 steps in the research process are;
• Identifying the Research Problem
• Reviewing of Literature
• Setting Research Questions, Objectives, and Hypotheses
• Choosing the Study Design
• Deciding on the Sample Design
• Collecting Data From The Research Sample
• Process and Analyze the Collected Research Data
• Writing Research Report

Step 1: Identify the Problem

• Finding an issue or formulating a research question is the first step.
• A well-defined research problem will guide the researcher through all
stages of the research process.
There are a number of approaches to get insight into a topic and gain a better
understanding of it. Such as:
• A preliminary survey
• Case studies
• Interviews with a small group of people
• Observational survey
Researchers need to identify both;
• Non-Research Problems
• Research Problem
• Statement of the Problem
• Justifying the Problem
• Analyzing the Problem

Step #2: LITERATURE REVIEW

The review of literature involves the systematic identification, location and
analysis of documents containing information related to the research problem
being investigated.
Purpose of literature review
• To determine what has already been done related to the research
problem being studied. This will help the researcher to: - Avoid
unnecessary and unintentional duplication.
• Form the framework within which the research findings are to be
interpreted.
• Demonstrate his or her familiarity with the existing body of knowledge.
• Helps reveal the strategies, procedures and measuring instruments that
have been found useful in investigating the problem in question. This will
help the researcher to:
• Avoid mistakes that have been made by other researchers
• Benefit from other researcher’s experiences
• Clarify how to use certain procedures, which one may only have learned
in theory.
• Helps to suggest other procedures and approaches, which will help,
improve the research study.
• Familiarizes the researcher with previous studies, which facilitates
interpretation of the results of the study. If there is a contradiction, the
literature review might provide rationale for the discrepancy.
• It helps the researcher to limit the research problem and to define it
better.
• Helps to determine new approaches and stimulates new ideas. The
researcher may be alerted to research possibilities, which have been
overlooked in the past.
• Approaches that have been proved to be futile will be revealed through
literature review.
• Specific suggestions and recommendations for further research can be
found by reviewing literature.

Steps in carrying out literature review

1. Familiarize yourself with the library before beginning the literature review
2. Make a list of key words or phrases to guide your literature search.
3. With the key words and phrases related to the study, one should go to the
source of literature.
4. Summarize the references on cards for easy organisation of the literature.
5. Once collected, the literature should be analyzed, organized and reported in
an orderly manner
6. Make an outline of the main topics or themes in order of presentation.
7. Analyze each reference in terms of the outline made and establish where it
will be most relevant.
8. The literature should be organized in such a way that the more general is
covered first before the researcher narrows down to that which is more specific
to the research problem. Sources of literature
(a) Primary sources: are direct descriptions of any occurrence by an individual
who actually observed or witnessed the occurrence.
(b) Secondary source: they include any publications written by an author who
was not a direct observer or participant in the events described

Examples
• Scholarly journals
• Theses and dissertations
• Government documents
• Papers presented at conferences
• Books
• References quoted in books
• International indices
• Abstracts
• Periodicals
• The Africana section of the library
• Reference section of the library
• Grey literature
• Inter-library loan
• The British lending library
 • The internet
• Microfilm
Tips on good review of literature
• Do not conduct a hurried review for fear of overlooking important
studies.
• Do not rely too heavily on secondary sources.
• Check daily newspapers as they contain very educative, current
information.
• Copy the references correctly in the first place so as to avoid the
frustration of trying to retrace a reference later.
• Do not only concentrate on findings, check on methodology and
measurement of variables

Step #3: Setting Research Questions, Objectives, and Hypotheses

• After discovering and defining the research problem, researchers should
make a formal statement of the problem leading to research objectives.
• A well-formulated, testable research hypothesis is the best expression of
a research objective.

Step #4: Choosing the Study DesignThe research design is the blueprint or
framework for fulfilling objectives and answering research questions.
• It is a master plan specifying the methods and procedures for collecting,
processing, and analyzing the collected data.
There are four basic research designs that a researcher can use to conduct their
study;
• survey,
• experiment,
• secondary data study, and
• observational study.

Step #5: Deciding on the Sample Design

Sampling is an important and separate step in the research process. The basic
idea of sampling is that it involves any procedure that uses a relatively small
number sample of a population to conclude the whole population.
Sample design refers to the methods followed in selecting a sample from the
population and the estimating technique vis-a-vis the formula for computing
the sample statistics.
These methods are basically of two types;
• probability sampling, and
• non-probability sampling

Step #6: Collecting Data From The Research Sample

• Data gathering may range from simple observation to a large-scale
survey in any defined population.
• There are many ways to collect data. The approach selected depends on
the objectives of the study, the research design, and the availability of
time, money, and personnel.
• With the variation in the type of data (qualitative or quantitative) to be
collected, the method of data collection also varies.
• The most common means for collecting quantitative data is the
structured interview.
• Studies that obtain data by interviewing respondents are called surveys.
Data can also be collected by using self-administered questionnaires.
Telephone interviewing is another way in which data may be collected.
• Other means of data collection include secondary sources, such as the
census, vital registration records, official documents, previous surveys,
etc.

Step #7: Process and Analyze the Collected Research Data

• Data processing generally begins with the editing and coding of data.
• Data are edited to ensure consistency across respondents and to locate
omissions if any.
Step #8: Writing Research Report – Developing Research Proposal, Writing
Report, Disseminating and Utilizing Results
The entire task of a research study is accumulated in a document called a
proposal or research proposal.
A research proposal is a work plan, prospectus, outline, offer, and a statement
of intent or commitment from an individual researcher or an organization to
produce a product or render a service to a potential client or sponsor.
A research report should contain sections on:
• An executive summary;
• Background of the problem;
• Literature review;
• Methodology;
• Findings;
• Discussion;
• Conclusions and
• Recommendations.

RESEARCH GAP
DEFINITION OF RESEARCH GAP:
A research gap is a key problem or a question that has not been answered by
any of the existing studies within your area of research
TYPES OF RESEARCH GAPS IN LITERATURE REVIEW
Evidence Gap
• An evidence gap means there is no evidence or insufficient
evidence to address the research.
• This gap involves contradictions in the findings of the prior
research
Knowledge Gap:
• The knowledge gap is a common gap in prior research. There are
two settings where a knowledge gap might occur.
• First, knowledge may not exist in the actual field of theories and
literature from related research domains.
• Second, it might be the case that the results of a study differ from
what was expected.
Practical-Knowledge Conflict Gap
• When professional behaviour or practice deviates from already
conducted research reports and findings
Methodological Gap
• A methodological gap is the type of gap that deals with the conflict
that occurs due to the influence of methodology on research
results.
Empirical Gap
• It is also known as evaluation void gap
• It relates to study conclusion that need to be experimentally
confirmed
Theoretical Gap
• Theoretical gaps is the one that deals with the gaps between theory and
earlier research
Population Gap
• It deals with population which is not adequately represented or under
researched in previous research. Eg – gender ,age ,race

7 Steps in formulating research problem

• Identifying a broad area
• Dissect the broad area (Involve People)
• Select a specific sub area
• Raise research questions
• Formulate your objectives (main and sub)
• Check the objective, feasibility and accountability
• Double check
Step 1: Identify a broad field or subject area of interest to you.
• This will help us to find an interesting topic, and one which may be of use to
us in the future it is a good idea to think about the field in which we would like
to work after graduation
Step 2: Dissect the broad areas into subareas
• In preparing this list of subareas we should also consult others who have
some knowledge of the area and the literature in our subject area.
Step 3: Select what is of most interest to you.
• One way to decide what interests us most is to start with the process of
elimination. We should go through our list and delete all those subareas in
which we are not very interested.
.Step 4: Raise research questions
• We should make a list of whatever questions come to our mind relating to
our chosen subarea and if we think there are too many to be manageable, go
through the process of elimination, as we did in Step 3.
Step 5: Formulate objectives
• Both our main objectives and our sub-objectives now need to be formulated,
which grow out of our research questions. The main difference between
objectives and research questions is the way in which they are written.
Formulation of Research problem Objectives
• Objectives are the goals we set out to attain in our study. Since these
objectives inform us of what we want to achieve through the study, it is
extremely important to word them clearly and specifically.
Step 6: Make sure
Now, we examine our objectives to ascertain the feasibility of achieving them
through our research process..
Step 7: Double-check
We should go back and give final consideration to whether or not we are
sufficiently interested in the study, and have adequate resources to undertake
it.

Difference Between Research Methods and Research Methodology:

• Research methods are procedures and techniques that are undertaken
to carry on research whereas research methodology is a system of
methods that helps in planning and executing the research.
• Research methods are nothing but the tools that are used to proceed
with research whereas research methodology analyses the way in which
the research is needed to be conducted.
• Research methods are basically implemented for conducting an
experiment like surveys, interviews, etc, whereas research methodology
is concerned with discovering different techniques to carry out the
experiment.
 • The research method’s primary main aim is to discover the problem at
hand whereas research methodology helps in finding the solution for
that problem.
• Research methods are applied at a later stage in the research whereas
research methodology is present from the initial stages of research.
• The tools that are used for building are the research methods and the
plan of that structure is the research methodology.
• Research method and research methodology are often used
synonymously but in reality, it is not accurate. Research methodology is
in fact a wider term and research methods are just a part of it. It can also
be said that research methodology is the genus of which research
methods are a species

Research Protocol

Purpose of protocol writing is to:-

• ➢ Clarify the research question

• ➢ Formulate hypothesis and objectives
• ➢ Decide about the study design
• ➢ Get ethical clearance
• ➢ Apply for funding
• ➢ Have a guideline and tool for research team
• ➢ The protocol should explain the study in terms of answers to the
study questions
It is generally written in the following format.
• Title
• Abstract/Summary
• Introduction
• Review of literature
• Aim and objectives
• Hypotheses
• Methodology
• Time line
 • Ethical consideration
• Budget
• Reporting format
• References
• Annexures
1. Title
• Title should be simple, accurate, informative and attractive.
• Specify the population to be investigated, and make the central
objectives and variable of the study clear to the reader.
• It should not be too long or too short.
• Better to be in one sentence with about 10-12 words.
2.Abstract/Summary:
• It is a sketch plan of the study, which provides quick details and general
plan of the study before getting into the main document.
• It should include the central elements like research problem, rationale,
methodology, population, time frame and expected outcomes.
3. Introduction:
• Introduction typically begins with a statement of the research problem in
a precise and clear term.
• Here the background, problem statement and significance or rationale of
the proposed research should be explained.
• The problem statement should be presented in a logical sequence as
follows and clearly specify the gaps in existing knowledge.
4. Literature Review:
• Review of literature is a very important part of a research project. All
available literature that supports the research idea should be
summarized.
• In this part definition of the problem, facts already known, weaknesses
and gaps in the literature etc should be mentioned.
• It describes the work done by others either at local or international level
on it or similar subject.
• It helps to prevent the duplication of work
5. Aim:
 Aim is broad but concise statement of what the research study hopes to prove.
Objectives refer to what would you actually do in this study to answer the
research question.
Objectives:
• Objective is a clear statement of the specific purpose of the study. There
may be more than one objective.
• The study objectives emerge from the research question.
• It may be presented as primary and secondary objective
6. Hypotheses
• Research hypotheses are the specific testable statements made about
the relationship between independent and dependent variables in the
study.
• In a proper scientific methodology a research hypotheses is stated not in
order to prove it but to test it.
• The study starts with the assumption that the research hypothesis is not
true. So the null hypothesis is to be stated first
7.Methodology:
• It is the most important part of research protocol and forms the core of
the research project.
• It should contain sufficient information about all the procedures planned
to achieve the objectives.
8.Study Design:

➢ Study design would vary according to the research problem. Study design
should be mentioned clearly and should be appropriate to answer the research
question.
Study Setting:

➢ This includes information about the location where the study will be
conducted eg community, school, hospital etc and the facilities available.
Study Population:
• Selection of study population should be done very carefully. We should
describe all the steps and decisions made in order to select the subjects
to be studied as this affects the external validity of the study.
Inclusion criteria:
• Inclusion criteria are the ‘characteristics’ required for a participant to be
included in the study.
• The criteria may be based on factors such as age,gender, the type and
stage of a disease, previous treatment history, and co-morbid medical
conditions.
Exclusion criteria:
• Details of participants who are considered ineligible to participate, even
though they are eligible as per inclusion criteria, and justification for
their
Sampling:
• All steps adopted in the recruitment of study subjects should be
described. The samples should be representative of the population.
Steps taken to minimize sampling errors should be clearly mentioned.
Sample size calculation:
• Sample size should be calculated based on each primary objectives and
higher number should be taken. It should be adequate to answer the
research questions and test statistical hypotheses.
Identification of variables:
• Variables are values that can change from subject to subject. It is
important to identify the variables at the planning stage itself.
• Knowledge of the variables- independent variables,dependent variables,
background variables/confounders in a research project are essential in
refining the objectives.
Interventions:
• Detailed description about the
intervention(drug/device/procedure/investigation etc) must be given.
• For drugs and devices that are commercially available, mention the
proprietary names,manufacturer, chemical composition,
storage,compounding, dose, frequency and method of administration.
Measurement / Data collection:
 • Instruments for measurement and method of measurement should be
given.
• Refer to the validity and reliability of the measurement instrument and
quality control measures should be specified.
Data Management and Statistical Analysis:
• This section should describe information on data access, confidentiality,
editing, coding,classification and tabulation of data.
• Statistical tests to be carried out in order to test each of the stated
hypotheses should be clearly outlined.
8. Time Line
• The protocol should specify the time that each phase of the project is
likely to take, along with a detailed month by month timeline for each
activity to be undertaken
9. Ethical and Legal Considerations
• This should explain how we are going to deal with ethical constrains to
the design and implementation of the study and ICMR guidelines could
be followed.
• It is not sufficient to state that we are going to respect these principles
but is to be explained how we are going to achieve that
10.Budget/Resources
• A brief outline of the budget requirement showing head wise
expenditure for the study should be given in this session.
• Eg: personnel, consumables, equipment, supplies,communication, funds
for patients, data processing,transportation etc.
• Justify the use of each item, consider the workplan of the study.
11.Dissemination activities/reporting
• Outline the planned publication/reporting strategy
• State how the results will be reported and who will be given access to
the data.
12.References
In this section list of the various references quoted while formulating protocol
may be listed in a
sequential manner.
Commonly used referencing systems are
• Harvard Style
• Name and publication year in text
• Alphabetical bibliography
• Vancouver Style
• Numbered references
• Continous referencing in text
• Make use of softwares like Zotero, Reference
• Manager or Endnote software.
12.Annexure
• The following documents should be appended
• Case Record Form
• Data collection tools/Questionaires
• Patient information form (in required languages)
• Consent form (in required languages)
• CV of investigators
• Letters of approval

Research ethics
Research ethics are the set of ethical guidelines that guides us on how scientific
research should be conducted and disseminated.
Research ethics govern the standards of conduct for scientific researchers It is
the guideline for responsibly conducting the research.
Research ethics committee/Institutional Review Board (IRB) reviews whether
the research is ethical enough or not to protect the rights, dignity and welfare
of the respondents.
Objective of research ethics
• To guard/protect human participants, their dignity, rights and welfare .
• To make sure that research is directed in a manner that assists welfares
of persons, groups and/or civilization as a whole.
 • To inspect particular research events and schemes for their ethical
reliability, considering issues such as the controlling risk, protection of
privacy and the progression of informed consent.
Ethical principles of research

• Honesty
• Integrity
• Objectivity
• Informed consent
• Respect for person
• Benefience(maximize the benefits of participants)
• Non malefience/ protecting the subject
• Responsible publication
• Protecting anonymity
• Confidentiality
• Non-discrimination
• Openness
• Carefulness and respect for intellectual property
• Justice
Broad Categorization of Principles of Research Ethics
1. MINIMIZING THE RISK OF HARM
It is necessary to minimize any sort of harm to the participants. There are a
number of forms of harm that participants can be exposed to. They are:
• Bodily harm to contributors.
• Psychological agony and embarrassment.
• Social drawback.
• Violation of participant’s confidentiality and privacy
2. OBTAINING INFORMED CONSENT

One of the fundamentals of research ethics is the notion of informed consent.

Informed consent means that a person knowingly, voluntarily and intelligently
gives consent to participate in a research.
Informed consent means that the participants should be well-informed about
the:
• Introduction and objective of the research
• Purpose of the discussion
• Anticipated advantages, benefits/harm from the research (if any)
• Use of research
• Their role in research
• Methods which will be used to protect anonymity and confidentiality of
the participant
• Freedom to not answer any question/withdraw from the research
• Who to contact if the participant need additional information about the
research
3. PROTECTING ANONYMITY AND CONFIDENTIALITY

Protecting the anonymity and confidentiality of research participants is an

additionally applied constituent of research ethics.
Protecting anonymity: It means keeping the participant anonymous. It involves
not revealing the name, caste or any other information about the participants
that may reveal his/her identity.
Maintaining confidentiality: It refers to ensuring that the information given by
the participant are confidential and not shared with anyone, except the
research team. It is also about keeping the information secretly from other
people.

4. AVOIDING MISLEADING PRACTICES

The researcher should avoid all the deceptive and misleading practices that
might misinform the respondent.
It includes avoiding all the activities like communicating wrong messages, giving
false assurance, giving false information etc.
5. PROVIDING THE RIGHT TO WITHDRAW
Participants have to have the right to withdraw at any point of the research.
When any respondent decides on to withdraw from the research, they should
not be stressed or forced in any manner to try to discontinue them from
withdrawing.
Advantages of Research Ethics
• Research ethics promote the aims of research.
• It increases trust among the researcher and the respondent.
• It is important to adhere to ethical principles in order to protect the
dignity, rights and welfare of research participants.
• Researchers can be held accountable and answerable for their actions.
• Ethics promote social and moral values.
• Promotes the ambitions of research, such as understanding, veracity, and
dodging of error.
• Ethical standards uphold the values that are vital to cooperative work,
such as belief, answerability, mutual respect, and impartiality.
• Ethical norms in research also aid to construct public upkeep for
research. People are more likely to trust a research project if they can
trust the worth and reliability of research.

Institutional review board

Introduction
The "Institutional Review Board" (IRB) is a local administrative body established
to protect the rights, safety, and well-being of human research subjects
recruited to participate in a clinical research.
The IRB has the authority to approve, require modification in, or disapprove
all research activities that fall within its jurisdiction. The IRB provides
assurances to research subjects that every reasonable attempt has been made
to protect their rights and safety as subjects.
RESPONSIBILITIES OF IRB
An IRB should safeguard the rights, safety, and well-being of all trial subjects.
The IRB should obtain the following documents
 • Trial protocol(s)/amendment(s) Written informed consent form(s).
• Subject recruitment procedures (e.g.: Advertise).
• Written information to be provided to subjects.
• Investigator's Brochure (IB).
• Available safety information.
• Information about payments and compensation.
• Investigator's current curriculum vitae.
• Any other may need to fulfill its responsibilities.

FUNCTIONS AND OPERATIONS OF IRB

• Only those IRB members who are independent of the clinical trial and
the Sponsor of the trial should vote / provide opinion in matters related
to the study.
• The IRB should perform its functions according to written standard
operating procedures, should maintain written records of its activities
and minutes of its meetings, and should comply with GCP and with the
applicable regulatory requirement(s).
• The investigator may provide information on any aspect of the trial, but
should not participate in the deliberations of the IRB or in the
vote/opinion of the IRB.
• The IRB should establish, document in writing, and follow its procedures,
which should include
• Determining its composition (names and qualifications of the members)
• Scheduling, notifying its members of, and conducting its meetings >
Conducting initial and continuing review of trials
• Determining the frequency of continuing review, as appropriate
• Specifying that no subject should be admitted to a trial before the IRB
issues
• Specifying that the investigator should promptly report to the IRB.
Deviations from, or changes of, the protocol to eliminate immediate
hazards to the trial subjects.
• Changes increasing the risk to subjects and/or affecting significantly the
conduct of the trial.
 • All adverse drug reactions (ADRs) that are both serious and unexpected.
New information that may affect adversely the safety of the subjects or
the conduct of the trial
• Ensuring that the IRB promptly notify in writing the
investigator/institution concerning.
• Its trial-related decisions/opinions. The reasons for its
decisions/opinions.
• Procedures for appeal of its decisions/opinions

The role of research and development in the pharmaceutical industry

"Research is the activity that makes pharmacy a science rather than a technical
skill"
Goals of Research In Pharmacy
• Advancement of pharmacy practice
• Promoting human health and societal well-being
• Promoting quality in institutions & the community
• Promoting professional development (promotion...etc.)
Types of Pharmacy Research

► Pharmaceutical research, includes the development and testing of new drug

dosage forms and drug preparation and administration methods and systems
‣ Clinical research, such as the therapeutic evaluation, comparison, and
outcomes of drug therapy and drug treatment regimens
Types of Pharmacy Research

► Pharmaceutical research, includes the development and testing of new drug

dosage forms and drug preparation and administration methods and systems
‣ Clinical research, such as the therapeutic evaluation, comparison, and
outcomes of drug therapy and drug treatment regimens
Research Career Pathways
• Academia
• Contract research organizations
• Healthcare institutional setting
• Industry
• Government
1) Academia
• A faculty appointment is the traditional pathway for a pharmacist to
pursue a research career
• Allows individuals to focus on a particular area of research and build an
independent, but typically collaborative, research career
• Most often associated with pharmacy colleges but may involve other
colleges (medicine, nursing)
Training required:
• Bachelor/Pharm.D. degree (entry level)
• Residency
• Fellowship
• MS/Ph.D. degree
• Additional degrees, e.g. master of business administration (M.B.A.) or
master of public health (M.P.H.) may be helpful in research focusing on
health outcomes or epidemiology

2) Contract Research Organization

Contract research organizations are private, independent companies that

assist and support investigators and industry in the research process
May be involved in various aspects of research including:

• protocol development
• protocol research
 • pharmacokinetic sample processing and analysis.
• data analysis
• preparation of regulatory reports and FDA applications
3) Healthcare Institutional Setting
• Research in the institutional setting is often self initiated within a
particular area of interest
• Type of research conducted is patient-focused through clinical drug
studies, evaluation of programs on patient outcomes, and economic
analysis
• Research opportunities often present themselves to clinical pharmacist
specialists who work in collaboration with other members of the health
care team

4) Industry
Provide opportunities to be involved in:
• Decision making and planning for new therapy development
• Collaborating with a variety of investigators on a national and
international level
• Participate in the administrative or management aspects of therapy
development

Training Required:
• Pharm.D. or Ph.D. are generally accepted as the minimum training
• Residency and fellowship training may be required
• The industry setting provides numerous opportunities for career
advancement, such as director positions, project manager and other
management roles
5) Government
• Research positions in government agencies e.g. Ministry of Health, Saudi
FDA
• Pharmacy researcher is a member of a large research team contributing
to the institute's overall research objectives and goals
 • Entry-level positions may include pharmacy research specialist with
advancement opportunities to director or manager of laboratory or
research programs
Training Required:
• For an entry-level position, a BS/Pharm.D. degree, residency/fellowship
may be also required
• Advanced positions, such as study director, laboratory director, or
section head, require a Pharm.D., residency/ fellowship
• Solid clinical and research experience is desirable
• Career advancement in the government is based on job experience and
success in current research endeavors