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INSTRUCTIONAL DESIGN AND ASSESSMENT Core Competencies for Research Training in the Clinical Pharmaceutical Sciences Samuel M. Poloyac, PharmD, PhD, Kerry M. Empey, PharmD, PhD, Lisa C. Rohan, PhD, Susan J. Skledar, MPH, BPharm, Philip E. Empey, PharmD, PhD, Thomas D. Nolin, PharmD, PhD, Robert R. Bies, PharmD, PhD, Robert B. Gibbs, PhD, Maggie Folan, BSN, PhD, and Patricia D. Kroboth, PhD University of Pittsburgh, School of Pharmacy Submitted October 15, 2010; accepted November 29, 2010; published March 10, 2011. Objective. To identify and apply core competencies for training students enrolled in the clinical pharmaceutical scientist PhD training program at the University of Pittsburgh School of Pharmacy. Design. Faculty members reached consensus on the required core competencies for the program and mapped them to curricular and experiential requirements. Assessment. A rubric was created based on core competencies spanning 8 major categories of pro- ficiency, and competencies of clinical versus traditional PhD training were delineated. A retrospective evaluation of the written comprehensive examinations of 12 former students was conducted using the rubric. Students scored above satisfactory in 11 out of 14 comprehensive examination metrics, with a mean score greater than 3.8 on a 5-point scale. Conclusions. The core competencies identified will provide an essential foundation for informed decision-making and assessment of PhD training in the clinical pharmaceutical sciences. Keywords: graduate education, competencies, clinical research, pharmaceutical sciences, doctor of philosophy degree INTRODUCTION Clinical pharmaceutical research is essential for the progression of novel preclinical discoveries into mean- ingful changes in patient care. Scientists with the unique skills to integrate basic pharmacology and the clinical pathogenesis of disease are highly sought in academia and the pharmaceutical industry. Clinical pharmacologists’ abil- ity to integrate preclinical and clinical evidence as it relates to drug response is a key factor necessary to reduce both the time of drug development and the likelihood of late-phase drug failures. 1 As with the pharmaceutical industry, trans- lation of preclinical research discoveries into meaningful therapeutic interventions has been a major initiative within academic settings. The creation of an infrastructure for clin- ical research within academic institutions by the National Institutes of Health (NIH) Clinical and Translational Sci- ence Awards (CTSA) has fueled the need for highly skilled researchers in the clinical pharmaceutical sciences. Despite the demand by academia and the pharma- ceutical industry, colleges and schools of pharmacy and medicine graduate too few researchers with skills in clin- ical pharmaceutical sciences and clinical pharmacology. Pharmaceutical scientists with skills in pharmacoge- netics, pharmacometric modeling and simulation, clinical pharmacotherapeutics, and pharmaceutics are in short supply. 1-3 In response to this demand, the number of col- leges and schools of pharmacy offering fellowship training, master’s degrees, and PhD degrees in the clinical pharma- ceutical sciences has grown significantly. In 2006, more than 40% of colleges or schools either offered or were planning to offer PharmD/PhD training programs in the pharmaceutical sciences. 4 Fellowship training programs also have attempted to address the need for more clinical researchers. The ideal method to train individuals with the skills to conduct clinical and translational research within the pharmaceutical sciences has been discussed extensively. 5-7 Nevertheless, the relatively small num- ber of trainees produced by all training programs is not meeting the needs of the research community. In 2006, the American Association of Colleges of Pharmacy (AACP) appointed an Educating Clinical Sci- entists Task Force to explore how academic pharmacy can increase the capacity and impact of pharmacy researchers in clinical and translational research. This task force de- veloped several essential policy statements focused on the Corresponding Author: Samuel M. Poloyac, 807 Salk Hall, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA 15261. Tel: 412-624-4595. Fax: 412-383-7436. E-mail: [email protected] American Journal of Pharmaceutical Education 2011; 75 (2) Article 27. 1

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INSTRUCTIONAL DESIGN AND ASSESSMENT

Core Competencies for Research Training in the ClinicalPharmaceutical Sciences

Samuel M. Poloyac, PharmD, PhD, Kerry M. Empey, PharmD, PhD, Lisa C. Rohan, PhD,Susan J. Skledar, MPH, BPharm, Philip E. Empey, PharmD, PhD, Thomas D. Nolin, PharmD, PhD,Robert R. Bies, PharmD, PhD, Robert B. Gibbs, PhD, Maggie Folan, BSN, PhD,and Patricia D. Kroboth, PhD

University of Pittsburgh, School of Pharmacy

Submitted October 15, 2010; accepted November 29, 2010; published March 10, 2011.

Objective. To identify and apply core competencies for training students enrolled in the clinicalpharmaceutical scientist PhD training program at the University of Pittsburgh School of Pharmacy.Design. Faculty members reached consensus on the required core competencies for the program andmapped them to curricular and experiential requirements.Assessment. A rubric was created based on core competencies spanning 8 major categories of pro-ficiency, and competencies of clinical versus traditional PhD training were delineated. A retrospectiveevaluation of the written comprehensive examinations of 12 former students was conducted using therubric. Students scored above satisfactory in 11 out of 14 comprehensive examination metrics, witha mean score greater than 3.8 on a 5-point scale.Conclusions. The core competencies identified will provide an essential foundation for informeddecision-making and assessment of PhD training in the clinical pharmaceutical sciences.

Keywords: graduate education, competencies, clinical research, pharmaceutical sciences, doctor of philosophydegree

INTRODUCTIONClinical pharmaceutical research is essential for the

progression of novel preclinical discoveries into mean-ingful changes in patient care. Scientists with the uniqueskills to integrate basic pharmacology and the clinicalpathogenesis of disease are highly sought in academia andthe pharmaceutical industry. Clinical pharmacologists’ abil-ity to integrate preclinical and clinical evidence as it relatesto drug response is a key factor necessary to reduce both thetime of drug development and the likelihood of late-phasedrug failures.1 As with the pharmaceutical industry, trans-lation of preclinical research discoveries into meaningfultherapeutic interventions has been a major initiative withinacademic settings. The creation of an infrastructure for clin-ical research within academic institutions by the NationalInstitutes of Health (NIH) Clinical and Translational Sci-ence Awards (CTSA) has fueled the need for highly skilledresearchers in the clinical pharmaceutical sciences.

Despite the demand by academia and the pharma-ceutical industry, colleges and schools of pharmacy and

medicine graduate too few researchers with skills in clin-ical pharmaceutical sciences and clinical pharmacology.Pharmaceutical scientists with skills in pharmacoge-netics, pharmacometric modeling and simulation, clinicalpharmacotherapeutics, and pharmaceutics are in shortsupply.1-3 In response to this demand, the number of col-leges and schools of pharmacy offering fellowship training,master’s degrees, and PhD degrees in the clinical pharma-ceutical sciences has grown significantly. In 2006, morethan 40% of colleges or schools either offered or wereplanning to offer PharmD/PhD training programs in thepharmaceutical sciences.4 Fellowship training programsalso have attempted to address the need for more clinicalresearchers. The ideal method to train individuals withthe skills to conduct clinical and translational researchwithin the pharmaceutical sciences has been discussedextensively.5-7 Nevertheless, the relatively small num-ber of trainees produced by all training programs is notmeeting the needs of the research community.

In 2006, the American Association of Colleges ofPharmacy (AACP) appointed an Educating Clinical Sci-entists Task Force to explore how academic pharmacy canincrease the capacity and impact of pharmacy researchersin clinical and translational research. This task force de-veloped several essential policy statements focused on the

Corresponding Author: Samuel M. Poloyac, 807 Salk Hall,School of Pharmacy, University of Pittsburgh, Pittsburgh, PA15261. Tel: 412-624-4595. Fax: 412-383-7436. E-mail:[email protected]

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education and training of future clinical pharmaceuticalscientists.8 In 2009, a follow-up summit was held with thegoal of reaching a consensus on the common and/or bestpractices among institutions offering clinical pharmaceu-tical scientist PhD training. General agreement wasreached that training individuals to conduct clinical andtranslational research is distinctly different from trainingindividuals with a PharmD degree to conduct traditionalPhD research in the pharmaceutical sciences. In otherwords, the addition of a basic science PhD to a prior PharmDdegree will not result in a scientist with the research skillsnecessary to rapidly initiate a career in clinically-orientedresearch. The summit participants universally agreed thatclinical pharmaceutical scientist training programs needto differentiate and specify the training requirements thatprepare graduates in the distinct discipline of clinical re-search in the pharmaceutical sciences. Furthermore, delin-eation of the specific core competencies for these studentswas deemed necessary to provide guidance for new pro-gram development and to identify the specific skillsattained by individuals completing a PhD in the clinicalpharmaceutical sciences.

Concurrent with the summit meetings, faculty mem-bers at the University of Pittsburgh School of Pharmacyidentified the core competencies for the Clinical Pharma-ceutical Scientist PhD Program. This effort was based onthe need to: (1) identify the specific training requirementsfor PharmD and non-PharmD students entering such pro-grams; (2) determine which courses from the Universityof Pittsburgh’s CTSA educational offerings should be in-cluded as curricular requirements for the program; and (3)increase the clarity of the differences in research trainingoffered by the clinical pharmaceutical sciences versustraditional graduate training. In March 2010, the Univer-sity of Pittsburgh School of Pharmacy finalized the corecompetencies and completed a mapping of these compe-tencies to the specific curricular and experiential offer-ings during training. Presented in this paper are the corecompetencies, the mapping of the competencies to thecurrent curriculum, and a retrospective evaluation of writ-ten comprehensive examinations to assess the utility ofthese competencies in evaluating student outcomes. Theexperiential components of our training program and theiruse in the assessment of programmatic outcomes also arediscussed.

DESIGNThe rationale for developing core competencies was

based on a programmatic need for informed decision-making on several issues, including core course require-ments, admission of non-PharmD students, and experientialrequirements for clinical pharmaceutical scientist students.

Since inception of the Clinical Pharmaceutical ScientistPhD Program at the University of Pittsburgh in the 1980s,34 students have completed PhD degrees and 1 student hascompleted a master’s degree. Of these graduates, 15 enteredthe program with a PharmD degree, 1 entered with a bach-elor of science in nursing (BSN) degree, and 19 entered witha master or bachelor of science degree in pharmacy or an-other science-related discipline. The program had severalinformal requirements for training BS versus PharmD stu-dents; however, consensus on the specific training require-ments for students based on their entry degree could not bereached. An informed group decision could not be madeunless a consensus was reached on the key competenciesexpected of all students within the graduate program regard-less of their training background. Therefore, our goal wasto develop a set of core competencies to guide decision-making processes with respect to curricular and experientialrequirements for the Clinical Pharmaceutical Scientist PhDProgram.

Core competencies were developed using a 3-stepprocess. First, the core competency task force was chargedwith identifying the key competencies necessary forcompletion of the Clinical Pharmaceutical Scientist PhDProgram. The group was asked to develop these compe-tencies without considering the content of currently of-fered courses. Once consensus on the core competencieswas achieved, the group refined and mapped the com-petencies to the current required and elective curricularofferings in the Clinical Pharmaceutical Scientist PhDProgram. The final step was to align the mapped corecompetencies to our previously developed assessmentmatrix of learning outcomes for the entire graduate pro-gram in pharmaceutical sciences.

The final core competencies then were opened forreview and recommendations from all faculty membersprior to implementation and dissemination. Feedback alsowas solicited from several students who had completed theprogram and had taken many of the classes being consideredas requirements for the curriculum. The learning objectivesfor our traditional PhD program and the core competenciesof our Clinical and Translational Science Institute were usedas guides in the development of the core competenciesdescribed.

Eight major categories of core competencies wereidentified (Table 1). Under each category, specific com-petencies were listed. An excerpt of the full core compe-tency document is provided in Figure 1. (The completedocument is available at www.pharmacy.pitt.edu/cps). Thehighest levels of Bloom’s Taxonomy were used to createthese individual competencies at the appropriate level forgraduate training outcomes. Each competency was thenmapped to the curricular and experiential offerings to

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which it corresponded in the Clinical Pharmaceutical Sci-entist PhD Program.

A significant issue addressed by the core competencydocument was the identification of the elements unique toclinical pharmaceutical scientist PhD training versus tra-ditional PhD training in the pharmaceutical sciences. Theclinical pharmaceutical scientist competencies detail theskills necessary to conduct independent, hypothesis-driven,ethically sound research in humans. This skill set is the keydifferentiator between training in the clinical versus tradi-tional pharmaceutical sciences. Examples of these specificskills include demonstration of the student’s ability to rec-ognize and explain the clinical and public health implica-tions of a given research hypothesis, and the ability toidentify important outcome measures to incorporate intoa patient-oriented clinical trial design. Fifteen clinical phar-maceutical scientist-specific competencies were identified(Table 2).

Within the program, several curricular and experien-tial components are aimed at meeting specific clinicalresearch core competencies. The curricular componentsspecific to the clinical pharmaceutical scientist traininginclude Introduction to Translational Research in theHealth Sciences and Clinical Research Methods. Intro-duction to Translational Research in the Health Sciencesis an interprofessional, graduate level course in whichstudents develop and justify a line of research that canhave a major impact on human health in the next 10 years.This project is completed as an interprofessional groupassignment. The course provides the intellectual frame-work for a career in clinical and translational research.The Clinical Research Methods course, a curricular offer-ing from the educational initiatives of the CTSA awardat the University of Pittsburgh, is aimed at providingstudents with the skills to design, implement, and interpretclinical research. For experiential requirements, studentsin the Clinical Pharmaceutical Scientist PhD Programmust include a human study in at least 1 aim of their writ-ten comprehensive examination. This examination requires

the student to submit a written NIH R01 formatted proposal,followed by an oral defense of that proposal in front of theirgraduate committee. Students also are required to serve asan investigator on an Institutional Review Board submis-sion during graduate studies. Finally, the student’s disser-tation research must include at least 1 chapter that involveshuman research as defined by the National Institutes ofHealth.9 Collectively, these experiential and curricular el-ements provide the foundation to achieve the identifiedcompetencies of the Clinical Pharmaceutical Scientist PhDProgram. As we move forward with these identified corecompetencies, our intent is to assess the entire curriculumand experiences to ensure the desired outcomes.

EVALUATION AND ASSESSMENTTo use the core competencies for assessment pur-

poses, we developed a rubric for the comprehensive ex-amination (Appendix 1). Fourteen core competencieswere associated with the comprehensive examination,6 of which were specific to the clinical pharmaceuticalscientist PhD. The goal of this assessment was to identifyhow many of these 14 core competencies were met by pastwritten examinations, and to identify areas of strengthsand weaknesses in our past written proposals. To accom-plish this goal, we obtained the written comprehensiveexaminations of 12 previous clinical pharmaceutical sci-ence graduate students. These 12 proposals were selectedbased on the availability of the written documents fromthe students who had most recently successfully completedthe Clinical Pharmaceutical Scientist PhD Program. Twofaculty members graded each of the 12 comprehensiveexaminations, which yielded 24 assessments. All of theexaminations were de-identified prior to grading. The ex-aminations were graded on a scale of 5 (excellent) to 1(unsatisfactory) for each of the competencies. The averagescores for each competency were determined and the per-centage of examinations receiving an average score of lessthan 3 (satisfactory) also was determined. The results areprovided in Table 3.

The majority of the core competencies for the writtencomprehensive examination were achieved (Table 3).Eleven of the 14 competencies were met by the majorityof students and had mean scores greater than 3.8 on a5-point scale. Three areas in which students were notconsistently meeting the new competencies were identi-fied. Two of these were related to human rights protectionand subject recruiting: (1) develop appropriate methodsto recruit and retain study participants for the selectedresearch design, and (2) demonstrate knowledge of thestandards of professional and ethical conduct establishedto guide researchers in protecting the rights, well-being,and dignity in the recruitment and retention of human

Table 1. Eight Major Categories of Core Competencies

Literature Review and EvaluationHypothesis GenerationResearch Methods and Study DesignStatistical Methods and Data EvaluationGrantsmanshipPresentation and Delivery of Oral and Written Scientific

InformationScientific Leadership, Management, and Cross-Disciplinary

TeamworkEthical Conduct of Research

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Figure 1. Example of the University of Pittsburgh Clinical Pharmaceutical Scientist Core Competency Grid with curricular andexperiential mapping. The asterisks indicate clinical pharmaceutical scientist PhD-specific competencies. Competencies notmarked with asterisks represent general skills to be acquired by all pharmaceutical sciences graduate students. (www.pharmacy.pitt.edu/cps.)

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subjects in clinical research. Although these competen-cies were being addressed in other portions of the curric-ulum, we thought that these competencies should beaddressed by the capstone comprehensive examination.Therefore, the guidelines for comprehensive proposalsnow emphasize that the human rights protections sectionis included (as described by NIH guidelines).10 Emphasisof this section ensures that this competency will beassessed as part of our comprehensive examination pro-cess in the future.

The third competency that was not being met fullywas the evaluation of possible problems in design andexecution of a study in the pharmaceutical sciences. Al-though this competency was being addressed in the oraldefense of the written proposal, the evaluation revealedthat several proposals failed to include a specific sectiondetailing the potential limitations of the proposed work.Therefore, the guidelines for the comprehensive exami-nation now specify that the written proposals include asubsection covering potential limitations after discussingthe anticipated results to ensure that this competency isbeing addressed. The comprehensive examination rubricnow is made available to graduate students to provide ad-ditional, previously undisclosed, guidance as they prepare

for this capstone assessment. We intend to use a similaron-going assessment approach to evaluate all curricularand experiential requirements and adjust content asneeded to ensure achievement of these competencies.

DISCUSSIONIn this manuscript we describe the core competencies

for clinical pharmaceutical scientist training developedat the University of Pittsburgh. It is our intent that thesecompetencies can be used to guide faculty members andothers to ensure that the quality, consistency, and expec-tations of training are being met through curricular andexperiential requirements. Specifically, the core compe-tencies will be used to develop methods to assess bothcurricular and experiential components of our ClinicalPharmaceutical Scientist PhD Program. Externally, thecompetency document will help clarify previously unre-solved questions about clinical pharmaceutical scientisttraining. For example, the 2009 Summit on Clinical Phar-maceutical Scientists Training Programs concluded thattraining a PharmD to do traditional PhD research in thepharmaceutical sciences differs from specific training inthe clinical pharmaceutical sciences. While the positiongenerally was agreed upon, a description of specific clinical

Table 2. Specific Competencies for Clinical Pharmaceutical Scientists

Literature Review and EvaluationDescribe the current state of knowledge about a biomedical, clinical, or public health problem.

Hypothesis GenerationDefend the clinical and public health implications of a given research hypothesis.

Research Design and MethodsDevelop appropriate methods to recruit and retain study participants for a selected research design.Identify important outcome measures for incorporation into patient-oriented clinical trial design.Generate a plan for data security/management.Identify barriers in translating research discoveries into meaningful changes in human health.Develop an approach to overcome barriers in translating research to humans.Design appropriate, ethically sound, and hypothesis-driven clinical studies.

Statistical Methods and Data EvaluationSelect the appropriate statistical approach for the interpretation of preclinical and clinical datasets.Define bias in clinical and translational research.

GrantsmanshipIdentify federal and non-federal agencies and programmatic initiatives aimed at translating research to clinical care of patients.Defend a written research proposal that describes specific research aims, significance, innovation, and approach for a human

clinical trial.Preparation and Delivery of Oral and Written Scientific Information

Assess the clinical implications of scientific information.Scientific Leadership, Management, and Cross-Disciplinary Teamwork

Develop a therapeutic protocol/guideline for medication-related issues or management.Ethical Conduct of Research

Demonstrate knowledge of the standards of professional and ethical conduct established to guide researchers in protecting therights, well-being, and dignity in the recruitment and retainment of human subjects in clinical research.

Give examples of the informed consent process including an understanding of the risk/benefit criteria and its impact onthe patient/volunteer.

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pharmaceutical science core competencies had not beenpreviously delineated. As a result, the lines have becomeblurred regarding what constitutes clinical pharmaceuti-cal scientist training. It is our intent to use these core com-petencies as a guide to define which specific courses andexperiences clearly differentiate clinical pharmaceuticalscientist training. Such information will be useful for otherschools of pharmacy as a guide for the development of com-petencies associated with new training programs at theirinstitutions. This information also may prove valuable torefine educational initiatives associated with CTSA andother clinical research educational initiatives.

Another issue raised at the 2009 Summit was the needto train both pharmacists and nonpharmacists in the clin-ical pharmaceutical sciences. In order to have a significantimpact on clinical research and secure support for suchprograms, colleges and schools of pharmacy need to trainboth PharmD and nonPharmD students in the clinicalpharmaceutical sciences. Although there is general con-sensus on this issue, the specific curricular and experien-tial requirements for a student entering our program withor without a PharmD degree were not clearly detailed.Because the developed core competencies apply to allstudents in the clinical pharmaceutical sciences, the com-

petencies will provide a framework for informed decision-making about the curricular and experiential requirementsnecessary to train all students entering the program regard-less of the entry-level degree earned.

SUMMARYCore competencies were developed for graduate

training in the Clinical Pharmaceutical Scientist PhD Pro-gram at the University of Pittsburgh School of Pharmacy.We describe the use of these competencies for rubric de-velopment and assessment of our capstone written compre-hensive examination. Through this process, we identifiedareas for improvement in our comprehensive examinationprocess, thereby developing additional guidelines to ensurethat all competencies are addressed. In addition, develop-ment of these competencies has allowed the specific skillsthat differentiate training in the clinical pharmaceuticalsciences from traditional pharmaceutical science PhDtraining to be defined.

ACKNOWLEDGMENTSThe project described was supported by Award Num-

ber KL2 RR024154 (KME, PEE) from the National Center

Table 3. Outcomes of the Written Comprehensive Examination Assessment Using the Core Competency Rubric

CompetencyMean Score(1 to 5 Scale)

ExaminationsAchieving

Score . 3, %

Extract literature from appropriate bibliographic sources. 4.6 100Critique clinical and scientific evidence derived from literature. 4.5 100Generate a relevant biomedical, clinical, public health, or translational

research hypothesis.4.3 100

Defend the clinical and public health implications of a given research hypothesis. 4.0 92Design appropriate experiments to address generated research questions in the

pharmaceutical sciences.4.3 100

Evaluate possible problems in the design and execution of a study in thepharmaceutical sciences.

3.0 50

Develop appropriate methods to recruit and retain study participants for aselected research design.

2.9 67

Identify important outcome measures for incorporation into patient-orientedclinical trial design.

3.8 92

Design appropriate, ethically sound, and hypothesis-driven clinical studies. 4.3 100Apply fundamental principles of statistical analysis, such as power analysis,

correlation, causation, regression, and summary statistics.4.3 92

Select the appropriate statistical approach for the interpretation of preclinicaland clinical datasets.

4.2 92

Develop appropriate conclusions based on results from research data. 4.0 92Assess the clinical implications of scientific information. 4.2 100Demonstrate knowledge of the standards of professional and ethical conduct

established to guide researchers in protecting the rights, well-being, anddignity in the recruitment and retention of human subjects in clinical research.

3.1 64

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for Research Resources. The content is solely the respon-sibility of the authors and does not necessarily representthe official views of the National Center for ResearchResources or the National Institutes of Health.

REFERENCES1. Honig P, Lalonde R. The economics of drug development: a grimreality and a role for clinical pharmacology. Clin Pharmacol Ther.2010;87(3):247-251.2. Fitzgerald GA. Opinion: anticipating change in drug development:the emerging era of translational medicine and therapeutics. Nat RevDrug Discov. 2005;4(10):815-818.3. Aronson JK, Barnett DB, Breckenridge AM, et al. The UK’s NHSand pharma: need for more clinical pharmacologists. Lancet.2009;373(9671):1251-1252.4. Gourley DR, Rowell C, Wingate L, et al. Status of PharmD/PhDprograms in colleges of pharmacy: the University of Tennessee dualPharmD/PhD program. Am J Pharm Educ. 2006;70(2):Article 44.

5. Dowling TC, Murphy JE, Kalus JS, et al. Recommended educationfor pharmacists as competitive clinical scientists. Pharmacotherapy.2009;29(2):236-244.6. Blouin RA, Pollack GM. Training clinical pharmaceuticalscientists in today’s highly competitive times: it’s time to commit tochange. Pharmacotherapy. 2009;29(2);6-7.7. Bauman JL, Evans WE. PharmD-only investigators are critical to theprofession: let’s preserve the fellowship as an equally important wayto prepare future clinical pharmaceutical scientists: or the case againstthe ‘‘all-PhD.’’ Pharmacotherapy. 2009;29(2):129-133.8. Blouin RA, Bergstrom RF, Ellingrod VL, et al. Report of the AACPeducating clinical scientists task force. Am J Pharm Educ. 2007;71(4):S05.9. Translational Research. National Institutes of Health. Division ofProgram Coordination, Planning, and Strategic Initiatives. http://nihroadmap.nih.gov/clinicalresearch/overview-translational.aspAccessed March 8, 2011.10. Research Involving Human Subjects. Office of ExtramuralResearch, National Institutes of Health. http://grants.nih.gov/grants/policy/hs/ Accessed March 8, 2011.

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ents

:

Des

ign

app

rop

riat

eex

per

imen

tsto

add

ress

gen

erat

edre

sear

chq

ues

tio

ns

inth

ep

har

mac

euti

cal

scie

nce

s.

Des

ign

edex

per

imen

tsw

ill

dir

ectl

yad

dre

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ep

rop

ose

dre

sear

chh

yp

oth

eses

Des

ign

edex

per

imen

tsw

ill

yie

ldso

me

info

rmat

ion

bu

tn

ot

add

ress

all

pro

po

sed

hy

po

thes

es

Des

ign

edex

per

imen

tsar

eu

nli

kel

yto

gen

erat

ed

ata

that

wo

uld

add

ress

the

pro

po

sed

hy

po

thes

es

Sco

re(5

-1)/

Co

mm

ents

:

Ev

alu

ate

po

ssib

lep

rob

lem

sin

the

des

ign

and

exec

uti

on

of

ast

ud

yin

the

ph

arm

aceu

tica

lsc

ien

ces.

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ten

tial

lim

itat

ion

so

fth

ep

rop

ose

dst

ud

yar

eth

oro

ug

hly

des

crib

ed

So

me

lim

itat

ion

sar

ep

rese

nte

db

ut

are

no

tco

mp

lete

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yli

ttle

dis

cuss

ion

of

the

po

ten

tial

lim

itat

ion

so

fth

ew

ork

are

pre

sen

ted

Sco

re(5

-1)/

Co

mm

ents

:

Dev

elo

pap

pro

pri

ate

met

ho

ds

tore

cru

itan

dre

tain

stu

dy

par

tici

pan

tsfo

ra

sele

cted

rese

arch

des

ign

.

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ep

lan

tore

cru

itan

dre

tain

sub

ject

sis

wel

ld

elin

eate

dT

he

pla

nto

recr

uit

and

reta

insu

bje

cts

ism

enti

on

edb

ut

no

tco

mp

lete

lyd

escr

ibed

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ep

lan

tore

cru

itan

dre

tain

sub

ject

sis

no

tw

ell

des

crib

ed

Sco

re(5

-1)/

Co

mm

ents

:

Iden

tify

imp

ort

ant

ou

tco

me

mea

sure

sfo

rin

corp

ora

tio

nin

top

atie

nt-

ori

ente

dcl

inic

altr

ial

des

ign

.

Pat

ien

to

utc

om

em

easu

res

are

app

rop

riat

ean

dw

ell

dev

elo

ped

Pat

ien

to

utc

om

em

easu

res

wer

eco

nsi

der

edb

ut

no

tfu

lly

dev

elo

ped

Pat

ien

to

utc

om

em

easu

res

wer

en

ot

wel

ld

escr

ibed

Sco

re(5

-1)/

Co

mm

ents

:

(Co

nti

nu

ed)

American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.

8

Page 9: INSTRUCTIONAL DESIGN AND ASSESSMENT Core Competencies for Research …archive.ajpe.org/aj7502/aj750227/aj750227.pdf · 2011. 3. 13. · Core Competencies for Research Training in

Ap

pen

dix

1.

(Co

nti

nu

ed)

Ca

teg

ory

Ex

cell

ent

Sa

tisf

act

ory

Un

sati

sfa

cto

ry5

31

Des

ign

app

rop

riat

e,et

hic

ally

sou

nd

,an

dh

yp

oth

esis

-dri

ven

clin

ical

stu

die

s.T

he

pro

po

sed

rese

arch

iset

hic

ally

sou

nd

and

app

rop

riat

eT

he

eth

ics

of

the

rese

arch

wer

eco

nsi

der

edb

ut

no

tfu

lly

just

ified

Th

eet

hic

so

fth

ep

rop

ose

dre

sear

chw

ere

no

tad

equ

atel

yco

nsi

der

ed

Sco

re(5

-1)/

Co

mm

ents

:

Ap

ply

fun

dam

enta

lp

rin

cip

les

of

stat

isti

cal

anal

ysi

s,su

chas

po

wer

anal

ysi

s,co

rrel

atio

n,

cau

sati

on

,re

gre

ssio

n,

and

sum

mar

yst

atis

tics

.

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app

rop

riat

est

atis

tica

lp

ow

eran

aly

sis

and

app

roac

hw

asd

evel

op

edan

dju

stifi

ed

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tist

ical

po

wer

and

app

roac

hto

anal

ysi

sw

asp

rese

nte

dw

ith

som

efl

aws

inu

nd

erst

and

ing

Th

est

atis

tica

lp

ow

eran

dap

pro

ach

wer

eei

ther

no

tp

rese

nte

do

rw

ere

ver

yp

oo

rly

just

ified

Sco

re(5

-1)/

Co

mm

ents

:

Sel

ect

the

app

rop

riat

est

atis

tica

lap

pro

ach

for

the

inte

rpre

tati

on

of

pre

clin

ical

and

clin

ical

dat

aset

s.

Stu

den

tse

lect

edan

dap

pro

pri

atel

yju

stifi

edth

ese

lect

edst

atis

tica

lap

pro

ach

So

me

bu

tn

ot

all

of

the

pro

po

sed

stat

isti

csw

ere

app

rop

riat

ely

sele

cted

and

/or

just

ified

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nifi

can

tfl

aws

inth

ese

lect

edst

atis

tics

wit

ha

po

or

just

ifica

tio

nan

du

nd

erst

and

ing

of

rati

on

ale

for

sele

ctio

n

Sco

re(5

-1)/

Co

mm

ents

:

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elo

pap

pro

pri

ate

con

clu

sio

ns

bas

edo

nre

sult

sfr

om

rese

arch

dat

a.T

he

anti

cip

ated

resu

lts

wer

eap

pro

pri

ate

and

wel

ld

evel

op

edT

he

anti

cip

ated

resu

lts

wer

eg

ener

ally

accu

rate

wit

hso

me

flaw

sin

just

ifica

tio

n

Th

ean

tici

pat

edre

sult

sw

ere

eith

ern

ot

pre

sen

ted

or

wer

ep

oo

rly

just

ified

Sco

re(5

-1)/

Co

mm

ents

:

Ass

ess

the

clin

ical

imp

lica

tio

ns

of

scie

nti

fic

info

rmat

ion

.T

he

stu

den

tw

rote

and

clea

rly

def

end

edth

eim

po

rtan

ceo

fth

ere

sear

chq

ues

tio

nas

itre

late

sto

the

curr

ent

stat

eo

fcl

inic

alp

ract

ice

Th

est

ud

ent

stat

edth

eim

po

rtan

ceo

fth

eq

ues

tio

nw

ith

resp

ect

tocl

inic

alp

ract

ice,

bu

td

idn

ot

clea

rly

stat

e/d

efen

dth

ed

irec

tre

lev

ance

Th

est

ud

ent

did

no

tcl

earl

yst

ate

or

def

end

the

imp

ort

ance

of

the

pro

po

sed

aim

sto

clin

ical

pra

ctic

e

Sco

re(5

-1)/

Co

mm

ents

:

Dem

on

stra

tek

no

wle

dg

eo

fth

est

and

ard

so

fp

rofe

ssio

nal

and

eth

ical

con

du

ctes

tab

lish

edto

gu

ide

rese

arch

ers

inp

rote

ctin

gth

eri

gh

ts,

wel

l-b

ein

g,

and

dig

nit

yin

the

recr

uit

men

tan

dre

ten

tio

no

fh

um

ansu

bje

cts

incl

inic

alre

sear

ch.

Stu

den

tin

clu

ded

ath

oro

ug

h,

wel

l-d

escr

ibed

hu

man

pro

tect

ion

sse

ctio

n

Stu

den

tin

clu

ded

ah

um

anp

rote

ctio

nse

ctio

nth

atw

asn

ot

full

yd

evel

op

ed

Th

est

ud

ent

did

no

tin

clu

de

ah

um

anp

rote

ctio

ns

sect

ion

Sco

re(5

-1)/

Co

mm

ents

:

American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.

9