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Research In Pharmacy. Outline. 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
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Outline • 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
Definition • Scientific research is the systematic, controlled, and critical investigation of hypothetical propositions (theories) about presumed relationships among natural phenomena
‘’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
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 ASHP statement on pharmaceutical research in organized health-care settings. Am J Hosp Pharm.1991; 48:1781
Types of Pharmacy Research • 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 ASHP statement on pharmaceutical research in organized health-care settings. Am J Hosp Pharm.1991; 48:1781
Characteristics Of A Successful Researcher • 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)
Components Of A Research Plan (Proposal) • A problem statement • A review of available literature on the subject • The objectives for the project • A description of the methodology to be used • A description of statistical analyses • A budget and time frame for the project • The expected applicability of the research findings • References ASHP guidelines for pharmaceutical research in organized health-care settings. Am J Hosp Pharm. 1989; 46:129–30.
Research Methods (Study Design) • 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
Components Of A Research Report • Problem a. Theories, hypotheses, and definitions b. Previous research: the literature • Methodology a. Sample and sampling method b. Experimental procedures and instrumentation c. Measurement of variables d. Statistical methods of analysis • Results, interpretation, and conclusions • References ASHP guidelines for pharmaceutical research in organized health-care settings. Am J Hosp Pharm. 1989; 46:129–30.
Barriers To Successful Research • 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
Research Career Pathways • Academia • Contract research organizations • Healthcare institutional setting • Industry • Government Pharmacy Practice Research Careers. Pharmacotherapy 2009;29(8):1007–1011
Research Career Pathways1) 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)
Research Career Pathways1) 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
Research Career Pathways1) 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
Research Career Pathways2) 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
Research Career Pathways2) 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
Research Career Pathways2) Contract Research Organization • 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 Career Pathways3) Healthcare Institutional Setting • 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
Research Career Pathways3) 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
Research Career Pathways3) Healthcare Institutional Setting • 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
Research Career Pathways3) Healthcare Institutional Setting • 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
Research Career Pathways4) 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
Research Career Pathways4) 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
Research Career Pathways5) 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
Research Career Pathways5) 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
Interested In Learning More About A Research Career ?? • 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