Preparing Clinical Pharmacy Scientists for Careers in

Clinical/Translational Research: Can We Meet the

Challenge?

ACCP Research Affairs Committee Commentary

Robert B. Parker, Vicki Ellingrod, Joseph T. DiPiro, Jerry L. Bauman, Robert A. Blouin, and

Lynda S. Welage

Developing clinical pharmacists’ research skills and their ability to compete for extramural funding isan important component of the American College of Clinical Pharmacy’s (ACCP) vision for pharma-cists to play a prominent role in generating the new knowledge used to guide patient pharmacother-apy. Given the recent emphasis on clinical/translational research at the National Institutes of Health(NIH) and the key role of drug therapy in the management of many diseases, there is an unprece-dented opportunity for the profession to contribute to this enterprise. A crucial question facing theprofession is whether we can generate enough appropriately trained scientists to take advantage ofthese opportunities to generate the new knowledge to advance drug therapy. Since the 2009 publica-tion of the ACCP Research Affairs Committee editorial recommending the Ph.D. degree (as opposed tofellowship training) as the optimal method for preparing pharmacists as clinical/translational scientists,significant changes have occurred in the economic, professional, political, and research environments.As a result, the 2012 ACCP Research Affairs Committee was charged with reexamining the college’sposition on training clinical pharmacy scientists in the context of these substantial environmentalchanges. In this commentary, the potential impact of these changes on opportunities for pharmacistsin clinical/translational research are discussed as are strategies for ACCP, colleges of pharmacy, andthe profession to increase the number and impact of clinical pharmacy scientists. Failure of our profes-sion to take advantage of these opportunities risks our ability to contribute substantively to thebiomedical research enterprise and ultimately improve the pharmacotherapy of our patients.KEY WORDS clinical pharmacy, research training, graduate training, clinical pharmaceutical scientists.(Pharmacotherapy 2013;33(12):e337–e346) doi: 10.1002/phar.1348

Fostering the development of clinical pharma-cists’ research skills and their ability to competefor extramural funding is an important compo-nent of the American College of Clinical Phar-macy’s (ACCP) strategic plan.1 ACCP’s vision is

that clinical pharmacy investigators will play aprominent role in generating the new knowledgeto be used to guide patient pharmacotherapy.Given the recent emphasis on clinical/transla-tional research at the National Institutes ofHealth (NIH) and the key role of drug therapyin the management of many diseases, there is anunprecedented opportunity for the profession tocontribute to this enterprise. Appropriatelytrained clinical pharmacists are uniquely posi-tioned to contribute to both T1 (bench-to-bedsideor laboratory-to-human research) and T2 (bed-side-to-patient research, health services research,

From the American College of Clinical Pharmacy,Lenexa, Kansas (all authors).

*Address for correspondence: Robert B. Parker, Universityof Tennessee College of Pharmacy, Department of ClinicalPharmacy, 881 Madison Avenue Room 346, Memphis, TN38163; e-mail: rparker@uthsc.edu.� 2013 Pharmacotherapy Publications, Inc.

A C C P C O M M E N T A R Y

drug effects in large populations, and compara-tive effectiveness research) translationalresearch. A crucial question for the pharmacyprofession is whether we can generate enoughappropriately trained scientists to take advantageof these opportunities to generate the newknowledge to advance drug therapy.In 2007, the ACCP Research Affairs Commit-

tee was charged by the Board of Regents todevelop a commentary on the optimal pathway(s)for developing clinical pharmacy scientists tocontribute substantively to biomedical research.This report, approved by the Board of Regentsin 2008 and published in 2009, recommendedthe Ph.D. degree (as opposed to fellowship train-ing) as the optimal method for preparing phar-macists to be competitive clinical/translationalscientists.2 To no one’s surprise, this stance gen-erated considerable controversy within ACCP,resulting in persuasive editorials on both sidesof the issue.3, 4

This issue of appropriate training for clinicalscientists has been debated for more than20 years: What is left to debate?3–6 The time forarguing whether graduate versus fellowshiptraining is optimal has passed and distracts theprofession from the more important question ofhow pharmacy can develop a critical mass ofclinical/translational researchers to meet theneeds of society. Since the ACCP commentarywas published, significant changes have occurredin the economic, professional, political, andresearch environments that pose important chal-lenges, as well as opportunities, for developingand sustaining training programs (either gradu-ate programs or fellowships) for clinical scien-tists with the Pharm.D. degree. In this report,the potential impact of these changes on oppor-tunities for pharmacy in clinical/translationalresearch is discussed, as are the ways in whichthe ACCP and colleges of pharmacy can increasethe number of pharmacists participating in clini-cal/translational research.

Recent Changes Affecting the Clinical/Translational Research Enterprise

Changes in the clinical/translational researchenterprise during the past 10 years have greatlyaffected the potential opportunities for clinicalpharmacy scientists. In September 2004, theNIH Roadmap recognized 12 roadblocks to bio-medical research and categorized these along thethree interrelated core “Roadmap” themes ofnew pathways to discovery, research teams of

the future, and reengineering of the clinicalresearch enterprise.7, 8

In response, the NIH launched the develop-ment of the clinical/translational science consor-tium, calling for the reengineering of the clinicalresearch enterprise and the training of futureresearch team members.9 Now part of the newNational Center for Advancing Translational Sci-ences (NCATS), the Clinical and TranslationalScience Awards (CTSAs) support ~60 institutions(see https://www.ctsacentral.org/ for more infor-mation). Although the CTSAs provide manyopportunities to foster translational researchwithin pharmacy, it is unfortunate that only 25 ofthe 126 colleges of pharmacy are CTSA affiliated.The recent development of NCATS by the

NIH was targeted to catalyze the development,assessment, and implementation of diagnostics,therapeutics, and devices across a wide spectrumof human diseases.10, 11 Although the creationof NCATS and the CTSAs has been a great stepforward for translational medicine, pharmacyresearch also encompasses comparative effective-ness research, which, as defined by the Agencyfor Healthcare Research and Quality (AHRQ),provides evidence on the effectiveness, benefits,and harms of different treatment options.12 In2010, as part of the Patient Protection andAffordable Care Act, a new nonprofit compara-tive effectiveness research entity known as thePatient-Centered Outcomes Research Institute(PCORI) was established (see www.pcori.org/for more information).13 PCORI provides newfunding opportunities for the expanding field ofcomparative effectiveness, and clinical pharmacyscientists could be uniquely positioned to addressmany of the research priorities. However, it isuncertain whether we are preparing adequatelytrained individuals in sufficient numbers to con-duct this type of research effectively because itrequires unique approaches that are not tradition-ally part of most pharmacy curriculums.Although opportunities abound, the research

landscape has simultaneously grown more com-petitive. The net result is a substantial decline infunding success rates for competitive grant sup-port through the NIH because of increases inR01 applications and increases in the averagesize of these awards (Figure 1). In fact, in the2011 and 2012 fiscal years, the overall successrates for NIH research project grants was only18%, an all-time low. The changing environmentfor clinical/translational research requiresindividuals to be highly trained to lead or bepart of new transdisciplinary research teams to

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be successful in today’s highly competitiveresearch environment.

Opportunities for Pharmacy in Clinical/Translational Research

The qualifications of clinical pharmacy scien-tists as a whole have become well recognized;thus the profession no longer must contend withthe question “Are clinical pharmacists qualified toconduct clinical research?”14 Yet some areas ofclinical research have only a few prominent clini-cal pharmacy scientist researchers. In other fields,however, clinical pharmacy scientist researchersare recognized at the top of their discipline. Nota-ble examples include pharmacogenomics, phar-macokinetics, and drug metabolism; clinical trialsin human immunodeficiency virus treatment andcardiovascular disease; pharmacovigilance; andhealth service research (e.g., pharmacoeconomicsand pharmacoepidemiology). These fields repre-sent important opportunities, particularly for

research-intensive colleges and schools of phar-macy within academic health centers. Moreover,the current health care environment has openednew opportunities to expand research in areassuch as comparative effectiveness research andmedication safety.This key question is central to the issue of

preparing well-trained clinical pharmacy scien-tists: What will be the future demand for theseindividuals in academia, the pharmaceuticalindustry, and the health service industry? In aca-demia, opportunities for clinical pharmacy scien-tists have been expanding, a trend that isexpected to continue.15 The pharmacy and med-ical education enterprises are expanding rapidlythrough the growth of existing colleges andschools. The push to increase research stemspartly from the Accreditation Council for Phar-macy Education (ACPE) standards for Pharm.D.programs, which include statements related toresearch and scholarship.16 Thus pharmacyschools are now facing competition to attract

Figure 1. Fiscal year 2012 overall success rates for National Institutes of Health research project grants.

PREPARING CLINICAL PHARMACY SCIENTISTS Parker et al. e339

successful researchers with federal grant fund-ing. Hence, although the specific opportunitiesfor clinical pharmacy scientists are changing,the overall demand for these researchers isincreasing.Historically, opportunities for growth in aca-

demia have been fueled by increased fundingfrom the NIH and have directed research careersalong traditional paths of biomedical research.Projections on future funding for the NIH arefor flat or declining budgets. Federal funding isnow shifting to other agencies within theDepartment of Health and Human Services, witha concomitant shift in research focus to issues oftreatment effectiveness, quality, and develop-ment of innovative wellness and health caredelivery models. This shift will open moreopportunities for which clinical pharmacy scien-tists are well positioned because of our roles asmedication experts. In addition, new models ofpharmacy practice and the advent of collabora-tive practices have begun to highlight the abili-ties of clinical pharmacists, creating a uniqueniche for the profession in research, apart fromtradition.Future opportunities for clinical pharmacy

scientists in the pharmaceutical industry areuncertain and difficult to predict. Data regard-ing pharmacists involved in industry researchare lacking, and predictions for career opportu-nities must be based on general industrytrends. For large pharmaceutical companies,mergers resulting in the downsizing of researchdepartments, reduced investment in new drugdevelopment, outsourcing of research activityto contract research organizations, and acquisi-tion of drugs at advanced stages of clinicaldevelopment have negatively affected opportu-nities for clinical pharmacy scientists. However,careers within contract research organizationsand small or startup pharmaceutical companieshave expanded. The issue of future opportuni-ties for clinical pharmacy scientists in thepharmaceutical industry is thus unpredictableright now.

Are Existing Training Programs Meeting theDemand?

There are an insufficient number of post-Pharm.D. research training programs (fellowshipor graduate based) to produce the highly com-petitive clinical/translational scientists necessaryto meet the growing demands of society. As aresult, gaps persist, and pharmacy is not well

positioned to contribute to the workforce needsof this rapidly evolving discipline. Pharmacy-educated clinical/translational scientists continueto have significant opportunities to make sub-stantive contributions to the biomedical and lifesciences research enterprise. However, the chal-lenge remains the same: educating and traininga critical mass of these individuals who canmake substantial contributions to advancing newtherapies or treatment strategies for improvinghuman health. Despite the increased opportuni-ties associated with the significant changes inthe research landscape, our ability to keep upwith the demand for properly trained and men-tored junior scientists has not improved. Twomajor obstacles remain that limit the pharmacyprofession in contributing its fair share of talentto the clinical/translational research enterprise: acritical mass of precursor talent and a criticalmass of qualified mentors working in high-endresearch environments conducting contemporaryclinical/translational research. These two issuesare codependent and must be addressed in tan-dem. In the paragraphs that follow, we discusscontemporary gaps in pharmacy-based educationprograms as well as potential opportunities mov-ing forward.

Attracting Outstanding Students to Careers inClinical/Translational Research

The pharmacy manpower environment haschanged considerably during the past 10 years,resulting in more students who could seek post-Pharm.D. training. These changes include:

• The proliferation and expansion of pharmacycolleges and schools within the United States,resulting in an oversupply of students seek-ing traditional pharmacy career tracks;

• The supply of postgraduate residency posi-tions being unable to keep pace with thedemand for qualified pharmacy students;

• The desire of pharmacy students to seek waysof differentiating themselves (i.e., dual degreeprograms, postgraduate residencies, andpostgraduate fellowships, as well as graduatetraining at the M.S. and Ph.D. levels); and

• The increased focus and funding opportuni-ties at the NIH to support clinical/transla-tional training and research.

These environmental changes offer newfoundopportunities to recruit highly qualified studentsto clinical/translational research careers inpharmacy. However, although some colleges and

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schools of pharmacy require a formal researchproject for all pharmacy students, not all haveadopted this approach. The profession in general,and research-intensive colleges and schools ofpharmacy in particular, must assume a moreaggressive, proactive position in orienting our stu-dents to research. All pharmacy students musthave a rich, fundamental understanding of theresearch process. Exposure to research in the pro-fessional curriculum will be essential, regardlessof students’ decisions to engage actively in aresearch career, because the cognitive skills mas-tered (i.e., the scientific method) through suchexperiences will be critical to their ability as prac-titioners to evolve as perpetual learners. Yet eventhough research careers are encouraged by ACPEStandards 2007, the logistic realities of a com-pacted curriculum make incorporating researchinto the curriculum challenging at best.16 In addi-tion, many of the new colleges and schools do notinclude research as a main component of theirmission; consequently, their Pharm.D. graduateshave limited opportunities to become involved inor exposed to research.17 To address this gap,curricular revisions should seriously considerincorporating more meaningful, impactfulresearch experiences for all of our students.Although student exposure to research is criti-

cal to developing our next generation of research-focused faculty, no viable organized mechanismcurrently exists for interested Pharm.D. studentsto learn about postgraduate training opportunities,especially if they are not at a research-intensiveschool. National organizations (e.g., AmericanSociety of Health-System Pharmacists [ASHP],American Pharmacists Association [APhA],American Association of Colleges of Pharmacy[AACP], and American Association of Pharmaceu-tical Scientists [AAPS]) provide avenues for pro-fessional students to learn about postgraduate year(PGY) 1 and PGY2 residencies in community andinstitutional practice, graduate programs, andpostdoctoral training. Certainly ASHP, with itsMidyear Clinical Meeting venue and ResidentMatching Program, has been successful in attract-ing and placing qualified students in postgraduateclinical practice training tracks (i.e., residencies);however, a similar type of networking session forresearch training does not exist.

Critical Mass of Qualified Mentors

Even if many pharmacy students were inter-ested in clinical/translational research, a secondobstacle, lack of a critical mass of qualified men-

tors working in high-end research environmentsconducting contemporary clinical/translationalresearch, would be another important factor lim-iting pharmacy’s contribution to the researchenterprise. Although garnering student interestin research is key, having successful researchfaculty from whom they can learn is also part ofthe issue. A July 2013 search of the AACP Fed-eral Grants database for principal investigatorsin departments of pharmacy practice or pharma-cotherapeutics/translational research identifiedonly 39 individuals with NIH, Veterans Adminis-tration, or AHRQ funding. Although this data-base has limitations (e.g., it covers only grantsfunded in the 2012 fiscal year, does not specifydegree of principal investigator, and omits phar-macists who do not work in colleges of phar-macy), it substantiates the lack of a critical massof qualified mentors.Although for many clinical pharmacists, the

traditional fellowship route has provided sub-stantial training and facilitated their overall suc-cess as clinical pharmacy scientists, changes inthe funding and educational landscape have lefteven some well-trained individuals unable tomaintain a research program successfully. Thisdisconnect between the faculty member’s desireto conduct research and the often inevitableshifts in effort allocations that result from thelack of funding has created a generation of phar-macy faculty who have become disenfranchisedfrom clinical research. In addition, inadequateresearch training has left many new tenure-trackfaculty members unable to obtain NIH fundssuccessfully, putting them in jeopardy of notsucceeding at promotion and tenure. Thusefforts to augment the research training of thesefaculty members, enabling them to retool theirresearch programs through sabbaticals or othermethods, should be explored. For research fac-ulty members who have successfully obtainedNIH support, use of the K24 mechanism shouldbe encouraged because this type of researchgrant allows salary support for the faculty’straining and mentoring efforts. By reengagingthese faculty members in the pharmacy researchenterprise, we can successfully increase thenumber of clinical scientist role models for ourstudents, in turn facilitating students’ interest inresearch. In addition, for those just beginning atenure-track position, we must pay extra atten-tion to their mentorship and continuing trainingneeds, perhaps incorporating delays of their ten-ure clock through a pre-tenure position mightbe well advised and help facilitate their research

PREPARING CLINICAL PHARMACY SCIENTISTS Parker et al. e341

success. Training grants such as the K30, K08,K23, or K99 may help these junior faculty mem-bers transition successfully to a tenure-trackposition and the overall successful attainment ofan independent research program. In addition,the K awards may be used by more senior fac-ulty who are now seeking a change in theirresearch focus but are unable to do so withoutadditional training in a specific area.

Current Postgraduate Pharm.D. Training

In the past 30 years, the pharmacy professionhas developed two main training strategies tomeet the challenge of producing a critical massof highly qualified clinical/translational researchscientists: fellowship and graduate training pro-grams. The approaches adopted by pharmacywere not novel, and although they producedoutstanding pharmacy scientists who have popu-lated the academic, industry, and governmentsectors, they are not meeting the currentdemand. The commitment by the NIH to reengi-neer the translational research enterprise (i.e.,the Roadmap and the creation of the CTSAs andNCATS), particularly in areas such as drug dis-covery and development, identification of thera-peutic targets, pharmacogenomics, repurposingapproved medications, and postmarketingresearch, directly aligns with work already beingconducted at many research-intensive colleges ofpharmacy.10 Thus the pharmacy profession has aunique opportunity to contribute to the criticalmass of talent that will ultimately meet this soci-etal need; however, new challenges must beovercome if we are to take advantage of theseopportunities.

Fellowship Programs

The number of research fellowship programshas declined since the heyday of fellowshiptraining in the 1980s and 1990s. An onlinesearch of the ACCP Directory identified only 57fellowship programs, a 33% decrease from the85 programs noted in the 2009 Research AffairsCommittee editorial.2 Reasons for this include adearth of candidates because of a previouslyvibrant job market, a trend that may be revers-ing, and a lack of reliable funding streams tosupport the fellow. The latter issue may havecontributed significantly to the loss of these fel-lowship programs because these fellows wereoften funded by residual balance funds fromindustry-sponsored research or other such

projects (which have substantially declined),grant awards from national organizations suchas ACCP or ASHP (which have since disap-peared), or modest investments by research-intensive colleges or schools of pharmacy.Fellowship programs have also suffered from

a lack of standardization, creating considerablevariability in the quality and rigor of the experi-ence. As a result, the scientific training ofPharm.D. research fellows may vary substan-tially, depending on the mentor and the pro-gram. The ACCP guidelines (also endorsed bythe American Association of Colleges of Phar-macy [AACP]) for fellowship training, mostrecently updated in 2004, have not changed sub-stantially since their inception in 1988.18 Theserepresent guidelines that are voluntary, and cur-rently, the ACCP Directory lists only sevenapproved fellowships.Depending on these fellowship programs to

produce a competitive clinical pharmacy scien-tist is challenging, given that some programsoften resemble PGY2 residency experiences witha research project attached. However, it is clearthat research fellowships can produce well-trained clinical pharmacy scientists becausethere are several examples of highly successfulindividuals in both academia and industry.Although completing a PGY1 residency programbefore beginning a fellowship program is prefer-able, the recent tightening of the job market forU.S. pharmacy students has potentially made fel-lowships a more visible and viable route forresearch training once again (see “Closing theGaps”).

Graduate Training Programs

Pharmacy-based graduate training programs inclinical/translational science have been in placefor more than 30 years. However, these post-Pharm.D. graduate training programs with theiremphasis on clinical/translational science havebeen slow to develop. In 2006, the AACPcommissioned a task force to assess and recom-mend strategies by which the pharmacy academycould increase the capacity and impact of com-petitive researchers in clinical/translationalresearch.5, 19 Several issues were identified, andspecific recommendations were advanced. Unfor-tunately, many of the same obstacles remaintoday, including

• The lack of interested precursor talententering these programs;

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• The failure of colleges and schools ofpharmacy to build the needed infrastructureto attract and retain scientists capable ofdeveloping and sustaining NIH-competitiveresearch programs in the clinical/transla-tional sciences;

• The inability of our colleges and schools ofpharmacy to attract a critical mass of scien-tists/scholars as faculty mentors capable ofproviding rigorous training experiences forgraduate students in the clinical/translationalsciences (although we could, in the shortterm, look outside the profession to fill thismentorship gap, longer term goals would beto have enough pharmacy mentors whowork with nonpharmacy mentors to providea transdisciplinary mentoring program);

• The challenge of developing a sustainablebusiness model to recruit and support thetraining and research expenses of thesegraduate students; and

• The difficulty of these programs in incorpo-rating and maintaining a strong “clinical”practice component within the graduatetraining experience to ensure that studentsmaintain a significant element of clinicalcompetence.

Similar to fellowship training programs, chal-lenges remain in clinical/translational graduatetraining programs that are associated with con-sistency in training experiences from one gradu-ate program to another.20 This variance includesinconsistencies associated with the identificationof a core curriculum, the amount and quality oftime the graduate student spends in the clinicalenvironment, and the nature of the clinical/translational research thesis project.In addition, these graduate training programs

are being significantly affected by the economicdownturn. These economic changes have thepotential of undermining, or at least challenging,how we approach the conduct and funding of allof our research and graduate training programs.Universities, particularly public universities,remain under threat because of declining statesupport, with the public colleges of pharmacyrepresenting most (but, of course, not all)research-intensive institutions. These institutionsshoulder the burden of providing most of thepharmacist-scientists for the nation. UnlikePharm.D. degree programs, graduate programsare generally not a primary source of income forresearch-intensive colleges and schools of phar-macy. Rather, many colleges invest substantial

sums in the form of teaching assistant orresearch assistant positions (in addition to infra-structure, etc.). Teaching assistant lines supportthe teaching mission of the colleges and schoolsbut also provide support for a young graduatestudent when grant support is unavailable. Col-leges and schools willing to invest in and pursuenew opportunities in clinical/translationalresearch must consider realigning their invest-ments in positions such as these and creatingthe proper mix of support for T1–T4 researchand training programs. Not all research-intensivecolleges and schools of pharmacy can or shouldperform all types of basic and translationalresearch, but rather, they must do some thingswell and perhaps not include others at all.Therefore, strategically investing in existingareas of research strength within a school/collegeand paying cautious attention to new and emerg-ing areas, combined with creating internal oper-ational efficiencies, will be necessary. Theseinvestment and operational decisions willrequire thoughtful engagement by the facultyand a consensus on the strategic research intentof the specific college.

Closing the Gaps

ACCP’s Role

ACCP has invested considerable resources tosupport the development of independent clini-cal pharmacy scientists. This is best exemplifiedby the Focused Investigator Training (FIT) Pro-gram, an “intensive, 5-day, hands-on programfor up to 18 experienced pharmacist investiga-tors who have not yet been awarded significantpeer-reviewed extramural funding as a principalinvestigator.” This type of training opportunitywas established as a solution to issues discussedearlier regarding faculty wishing to retool theircurrent research program or needing additionaltraining to be competitive in the current envi-ronment. Moreover, this program is an excep-tional training opportunity for junior faculty asthey enter tenure-track positions. As indicatedfrom current ACCP data, the 2008 FIT Programclass has been awarded more than $2.6 millionin new grants. In the first 3 years of the FIT,55 individuals graduated from the program. Weoffer the following points for consideration asthis program moves forward:

• It is time for ACCP to reevaluate its strate-gies to optimally prepare FIT participants

PREPARING CLINICAL PHARMACY SCIENTISTS Parker et al. e343

for collaborative science, consistent with theCTSA and NCATS initiatives;

• The FIT Programmust prepare its participantsfor collaborative opportunities within theCTSA network. For example, applicants to theFIT Program should consider bringing a pro-ject that builds on current CTSA pilot grantfunding to take this research to the next level.

ACCP has the opportunity as an organizationto capitalize on the recent emphasis on clinical/translational research to support its membersand the scientific contributions of clinical phar-macy. We offer the following recommendationsfor consideration and discussion by ACCP in col-laboration with other professional organizations:

• ACCP should work closely with other phar-macy organizations to strengthen its posi-tion of influence within the CTSA hierarchyby collaborating with current pharmacyCTSA members to highlight the unique rolepharmacy plays. Exclusion from these areascould permanently disadvantage its mem-bership in the conduct of meaningful, effec-tive clinical research.

• ACCP should work with other major phar-macy organizations in creating a “PharmacyResearch Council” to represent the collec-tive research and related training interestsof the pharmacy academy by initiating thefollowing charges.

○ Develop unified standards and definitionsrelated to the education and training ofpharmacy students, residents, fellows,and graduate students regarding thepreparation of clinical/translational scien-tists.

○ Create an electronic portal that wouldfacilitate communication and interactionbetween pharmacy students and researchfellowship preceptors and graduate pro-grams;

○ Create a venue for pharmacy students tointeract and ultimately match withresearch fellowship preceptors and gradu-ate programs;

○ Present to the NIH a clear vision andunderstanding of the potential contribu-tions pharmacy can make to the biomedi-cal, life sciences enterprise;

○ Present to the leadership of the CTSAs andNCATS a summary of the important trans-lational science being conducted by con-temporary colleges and schools of

pharmacy, often in collaboration withexisting CTSA sites;

○ Develop a Web-based database of clinicalpharmacy scientists with federal researchsupport to track the number of individu-als with funding so that our progresstoward a critical mass of clinical/transla-tional scientists can be monitored; and

○ Provide funding for pharmacy fellowshipprograms by establishing a fellowshipendowment through the ACCP ResearchInstitute.

Finally, we recommend that ACCP perform athoughtful analysis of its current guidelinesrelated to fellowship training programs and, ifnecessary, reenergize the fellowship review oraccreditation process. Such an analysis is war-ranted in light of the many environmental changesthat have recently taken place within academiaand the pharmaceutical industry. In addition, theemphasis currently placed on translational/clini-cal science by the NIH, Food and Drug Adminis-tration, and pharmaceutical industry will createnew opportunities for research training programs.However, we urge ACCP to take a fresh look atthese program guidelines from the perspective ofprerequisite training, academic rigor, quality ofmentoring, and quantity and quality of theresearch to be conducted by the fellow.

Reconsideration of Training Pathways toIncrease the Critical Mass of Clinical/Translational Scientists

Much has been written and debated regardingthe “preferred” route of training for clinicalpharmacy scientists; we will not rehash thesediscussions.3, 4 With the perceived need toincrease the number of well-trained clinical/translational scientists, there is clearly a capacityto accommodate both pharmacists with fellow-ship training and those with the Ph.D. degree.In most public research-intensive colleges andschools of pharmacy, most students enter with abachelor’s degree in one of the sciences. Thus,for instance, combined Pharm.D./Ph.D. programsshould be built such that the coursework neces-sary for the Ph.D. portion is completed duringPharm.D. training, leaving only the research the-sis work required to complete the Ph.D. portion.New models of fellowship training are also

required. To ensure adequate coursework andrigor, some have combined master’s-level degreeswith fellowships. We support this, but of course,

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it lengthens the time to completion and/or maydetract from performing clinical research for a 2-to 3-year fixed period (as most fellowships tend tobe). Some colleges have created a menu of com-bined degree programs (e.g., Pharm.D., master’sdegrees); examples of this are the Pharm.D./M.S.and the Pharm.D./MPH. Efficiencies in time tocompletion of the master’s degrees are realizedduring the Pharm.D. program (electives in thePharm.D. program apply to the master’s degree),generally extending the time to completion of thecombined degree by only 1 year.One particular degree program that may hold

substantial promise for training clinical phar-macy scientists is the M.S. degree in clinical/translational science, generally funded to institu-tions through the NIH K30 program and oftenhoused within the institution’s CTSA. This pro-gram often targets practicing physicians, den-tists, or pharmacists who are intent onincreasing their skills in clinical research, but itcould also be applied to medical or pharmacystudents. As part of their M.S. degree program,students must complete a research project underthe direction of a mentoring faculty member. Ifthe student chooses a clinical pharmacy facultymember, an opportunity could be provided tomove directly to a research fellowship (or per-haps a Ph.D. program). Hence the combinedPharm.D./M.S. degree in clinical/translationalscience (or other combined Pharm.D./master’s-level degrees) could provide a pipeline for andpathway to postdoctoral fellowship training.However, many research fellowship programsrequire at least a PGY1 residency before theactual fellowship. Because this further prolongsthe time in training, perhaps it is time to rethinkthis requirement, with the advent of the earlyexperiential clerkships now necessary in curricu-lums and with many schools increasing the timeand requirements for advanced experiential rota-tions. Perhaps we could move instead towardtraining clinical pharmacy scientists through theM.S. degree in clinical/translational science.

Conclusions

Significant changes have recently occurred inthe pharmacy profession, as well as in thesurrounding economic, political, and researchenvironments, that may substantially affect oppor-tunities for training and developing clinical phar-macy scientists. With these unprecedentedopportunities for pharmacist participation in theclinical/translational research enterprise (e.g.,

focus of the NIH on clinical/translational research;creation of the CTSAs and NCATS; growing inter-est in comparative effectiveness, health services,and patient-centered research), important ques-tions remain about whether the profession candevelop and sustain a critical mass of well-trainedindividuals to take advantage of them. Our profes-sion and professional organizations have failed toarticulate a clear and definitive strategy to exploitthis opportunity, and our profession as a wholehas deprioritized research, resulting in the inabil-ity to sufficiently foster student interest in aresearch career. Whether post-Pharm.D. fellow-ship training or a graduate program resulting inthe Ph.D. degree is the “optimal” pathway fortraining clinical pharmacy scientists is now a rela-tively minor issue compared with the need to gen-erate a larger number of appropriately trainedscientists. ACCP has been a leading advocate forthe importance of pharmacists’ participation inclinical/translational research. The time is now forACCP, in collaboration with other pharmacy orga-nizations, to develop meaningful strategies forincreasing the number and impact of clinical phar-macy scientists. To do otherwise would risksquandering this great opportunity for our profes-sion to substantively contribute, not only to thebiomedical research enterprise but also toadvances that will ultimately improve patient care.

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