Research In Pharmacy

Research In Pharmacy

Definition of research Goals of research in pharmacy Types of pharmacy research Characteristics of a successful researcher Components of a research plan Research Methods Research career pathways◦Academia◦Contract research organizations◦Healthcare institutional setting◦ Industry◦Government

Outline

Scientific research is the systematic, controlled, and critical investigation of hypothetical propositions (theories) about presumed relationships among natural phenomena

Definition

‘’Research is the activity that makes pharmacy a science rather than a technical skill’’

The 1980 American Association of Colleges of Pharmacy Argus Commission Report

Advancement of pharmacy practice

Promoting human health and societal well-being

Promoting quality in institutions & the community

Promoting professional development (promotion…etc.)

Goals of Research In Pharmacy

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

ASHP statement on pharmaceutical research in organized health-care settings. Am J Hosp Pharm.1991; 48:1781

Health services research and development, includes behavioral and socioeconomic research such as research on cost–benefit issues in pharmaceutical care

Operations research, such as evaluation of new and existing pharmacy programs and services

Types of Pharmacy Research

ASHP statement on pharmaceutical research in organized health-care settings. Am J Hosp Pharm.1991; 48:1781

Self-motivation Attention to detail Excellent time-management skills Strong written and verbal communication skills Ability to work independently Creativity, curiosity, patience, and passion to search for

new knowledge Keep abreast of scientific and clinical literature

Characteristics Of A Successful Researcher

Ability to ask questions, create research hypotheses,& design methodologies to answer research questions

Ability to interpret results and identify the strengths and weaknesses of the literature

Establishing collaborations with others to grow and strengthen research programs

Disseminating and sharing the results of one’s findings (at scientific meetings, publication in scientific journals)

Characteristics Of A Successful Researcher

1. A problem statement2. A review of available literature on the subject3. The objectives for the project4. A description of the methodology to be used5. A description of statistical analyses6. A budget and time frame for the project7. The expected applicability of the research findings8. References

Components Of A Research Plan (Proposal)

ASHP guidelines for pharmaceutical research in organized health-care settings. Am J Hosp Pharm. 1989; 46:129–30.

Cross-sectional Study◦Data collected from the population on one occasion only

Before-and-after Study◦ 2 cross-sectional observations (e.g. before & after an

intervention)

Longitudinal (Cohort) Study◦ Follows up a sample (cohort) of individuals over a period

of time◦Data will be collected from each individual on more than ◦ one occasion

Research Methods (Study Design)

Exploratory Study◦ Investigate a topic from the perspective of different people

& identify issues that are important to them

Retrospective Study◦Collecting data related to what has happened in the past

Prospective Study◦Collecting data relating to the future

Research Methods (Study Design)

1. Problema. Theories, hypotheses, and definitionsb. Previous research: the literature

2. Methodologya. Sample and sampling methodb. Experimental procedures and instrumentationc. Measurement of variablesd. Statistical methods of analysis

3. Results, interpretation, and conclusions4. References

Components Of A Research Report

ASHP guidelines for pharmaceutical research in organized health-care settings. Am J Hosp Pharm. 1989; 46:129–30.

Insufficient time because of clinical, teaching, administrative responsibilities

Insufficient funding and extremely competitive grants

Inability to generate ideas for relevant research

Lack of collaborators and/or mentors

Lack of availability of advanced training opportunities

Barriers To Successful Research

Academia

Contract research organizations

Healthcare institutional setting

Industry

Government

Research Career Pathways

Pharmacy Practice Research Careers. Pharmacotherapy 2009;29(8):1007–1011

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)


1) Academia

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


1) Academia

Faculty positions require individuals to contribute to teaching at undergraduate or graduate level &, in some instances, maintain a clinical service component

Research settings may include:◦ Laboratory◦Clinics & hospitals◦Community pharmacy settings◦Classroom◦Government◦ Industry


1) Academia

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


2) Contract Research Organization

Although entry-level positions are available, job experience open more opportunities

Research responsibilities for individuals working in CRO positions include:◦ protocol development◦ project management◦writing and review◦ data analysis◦ administrative duties◦manuscript preparation



Training Required: BS/Pharm.D. and/or Ph.D. or master of science degree (M.S.)

The extent and type of previous job experience will influence the type of CRO positions available:

◦Entry-level jobs tend to be involved more in the field & conducting research

◦Career advancement is primarily to research project planning & more administrative aspects of negotiating and executing contracts



Research in institutional setting (e.g. hospital) in the role of a clinical pharmacy specialist

A research protocol is often required to document pharmacist activities impact on patient outcomes or costs

Training Required:◦Bachelor/Pharm.D. degree and, at a minimum, a

pharmacy practice residency◦Master’s degree with experience may be acceptable◦ Fellowship training is also beneficial


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



Other responsibilities of clinical pharmacy specialists involved in research include:

◦Precepting students or residents ◦Participating in clinical protocol development or writing ◦Analyzing data◦Reviewing and writing research grants and manuscripts◦Serving on institutional review boards



Additional career path in a health system or hospital setting is as an investigational drug service pharmacist:

◦Responsible for providing drug distribution to clinical research trials

◦May participate in the drafting of research protocols involving drug administration

◦Often serve on institutional review boards to ensure safe medication practices during clinical research trials

◦Participate in research process, rather than have direct involvement in hypothesis generation



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


4) Industry

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


4) Industry

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


5) Government

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


5) Government


Academia Vs. Industry

Academia Industry

Options & Choices

• Faculty have the option to select their own research topics, and

• Spend as much time on the topic as desired

• Research is more or less governed by the market demand

• Specific timelines must be met

Publication of Work

• More emphasis is placed on publication

• Researchers also are encouraged to present their work at symposiums and conferences

• Less emphasis on publication

• Researchers are recognized based on project management skills and the end product of their research


Academia Vs. Industry

Academia Industry

Resources & Funding

• Often have to rely on external organizations (e.g. government) for funding

• Self-funded• Easy access to resources

Career Options

• Faculty may set up their own research laboratory

• May also serve as evaluators of research proposals and research findings

• After a few years of research,pharmaceutical scientists become more involved in management & decision making & spend less time in the lab

To gain insight regarding job scope and activities:

◦Meet with people in the sector of interest◦Examine publications written by researchers from the

sector of interest◦Consider job shadowing◦Consider elective rotations with a researcher

Interested In Learning More About A Research Career ??

Documents

Research In Pharmacy