Drafted by SOM Clinical Research Crdinatrs Strengths: Clinical Research Crdinatrs Vested in patients psitive utcme Vested in subjects safety Vested in cnducting clinical research in cmpliance with all applicable rules, regulatins, and current Gd Clinical Practices (GCP) fr research Dedicated, willing t d what it takes t get the jb dne Educatinal backgrund Institutinal CRC hiring plicy supprts and requires (in mst cases) minimum f a cllege degree r an RN license High percentage f certified Clinical Research Crdinatrs Institutin supprts and encurages certificatin High number f CRCs at UVa have many years f clinical research knwledge/experience New Clinical Research Unit (CRU) n Barringer 3 Beautiful, cmfrtable space fr clinical research subjects Efficient, well-equipped space fr clinical research staff t cnduct their trials Accmmdating, CRU staff wh are available t cnduct research study visits PRN pl f staff available t assist with studies cnducted n the CRU Lab prcessing facilities in Barringer 3 (as well as in the Medical Center) available t all research staff SOM Clinical Trials Office (CTO) Advcates fr clinical research staff Prvides critical services fr the clinical research prcess Excellent resurce fr clinical research staff Institutinal Review Bard (IRB) Generally respnsive nt reactive Full bard prtcl apprval times have decreased ver the years Full bard prtcl apprval times less than IRBs at sme ther academic medical centers (and with fewer IRBs) Cmbines HIPAA prcess with infrmed cnsent prcess s they dn t have t be dne separately Multiple training effrts (e.g. IRB 101, IRB 201, learning shts) Cancer Center Investigatinal Drug Services Respnsive and accurate service Diverse educatin/backgrund f Clinical Research Crdinatrs (licensed and nn-licensed) Independent thinkers able t wrk independently Multiple rganizatinal structures fr Clinical Research Crdinatrs April 16, 2014 1
Drafted by SOM Clinical Research Crdinatrs Team structure (a team f CRCs wrking fr a team f investigatrs) Allws fr back-up when needed Allws fr team apprach t prblem-slving, etc. Prvides pssibility fr career grwth within the team One-t-ne structure (ne CRC wrking with ne Principal Investigatr (PI) Prvides pprtunity t becme highly specialized in a medical specialty Allws fr independence Prvides pprtunity t learn entire research prcess New clinical career ladder fr Clinical Research Crdinatrs Pst Apprval Mnitring reviews Prvides nn-threatening feedback t research teams Identifies study-cnduct related issues and prvides pprtunity t crrect them Prvides educatinal pprtunity t research teams Epic Increasingly prviding mre features that may imprve safety f subjects enrlled in clinical trials Increasingly prviding mre features that may imprve efficiency f cnducting trials Ability t prvide mnitrs the capability f remte mnitring Clinical Research website Finally there is ne site fr a clinical researcher t g t find answers t research-related questins Weaknesses Funding issues Lack f funding r frequent lsses f funding gives CRCs a lack f jb security, a feeling f instability N/little bridge funding Leads t jb hpping Leaves PIs withut a CRC when next study starts Barriers created between Medical Center and University Human Resurces plicies differ which makes it difficult t attract Medical Center emplyees t academic psitins, makes it difficult fr them t wrk in a dual capacity, etc. Medical Center staff nt being willing/able (mst times due t being already verladed with patient care respnsibilities) t cntribute t the research prcess (i.e., n time t perfrm study-related activities such as vital signs, administer study meds, draw bld during night shift, etc.) This increases the cst f ding studies, many f which (gvernment funded r investigatr initiated) cannt bear the csts April 16, 2014 2
Drafted by SOM Clinical Research Crdinatrs N infrastructure in place t help alleviate this prblem (even when attempts were made t cmpensate smene frm the Medical Center t perfrm such tasks, the HR plicies prevented it frm mving frward) Unspken message frm many Medical Center emplyees that research has a negative impact Research can impact the cre measures n which units are being evaluated Less than perfect cmmunicatin at times between Medical Center and clinical research teams Multiple rganizatinal structures fr Clinical Research Crdinatrs Team structure (a team f CRCs wrking fr a team f investigatrs) Decreases feeling f independence Increases pssibility f lsing sight f the big picture, nly being able t fcus n specific delegated tasks One-t-ne structure (ne CRC wrking with ne Principal Investigatr (PI) Presents greater chance f inefficiencies and/r incnsistencies Presents greater chance f CRC feeling islated CRC retentin issues Despite new career ladder, there are limited pprtunities fr advancement fr CRCs Hard t cmpete with industry we many times train new CRCs, nly t have them leave fr industry psitins Lack f clinical trial management system (CTMS) that culd facilitate the entire clinical research prcess, frm pre-award t pst-award. Limited required educatin fr new clinical research staff Institutinal Review Bard Expedited prtcl pre-review time unacceptably lng and arduus IRB website can be hard t navigate, n search engine n site Prtcl Builder questins can be hard t interpret, despite help prvided Incrrect interpretatin can lead t significant time delays and/r rewrk Incnsistency in respnses frm different IRB staff members when presented with questins Electrnic IRB submissin prcess nt available Office f Spnsred Prgrams Turnver rate seems high Prcess takes t much time N electrnic web-based prcess t supprt the pre-award and pst-award prcess Lack f cnsistent set f prcesses Website can be difficult t navigate April 16, 2014 3
Drafted by SOM Clinical Research Crdinatrs N (r limited) training fr Principal Investigatrs is available N centralized supprt fr first time, r ne-time PIs (in sme cases basic researchers starting a simple study where all they need is bld r tissue samples). In many instances, these PIs are nt familiar with the study start-up prcess and have n supprt persnnel t assist with the prcess. Therefre, they becme frustrated and struggle with the prcess. PIs nt always aware f everything that is invlved with crdinating a clinical research study. They many times under estimate the amunt f effrt it requires. Lack f understanding n the part f sme research team members f the difference between research and practice, which can lead t prtcl nn-cmpliance, have regulatry implicatins, and impact data integrity. Limited internal infrastructure N central supprt fr prtcl writing/develpment is available t research staff utside the Cancer Center Limited central supprt available fr IRB submissin supprt N central supprt fr managing multi-center studies Lack f billing system that integrates easily with Epic makes clinical trial billing cumbersme Hurs f the Birepsitry and Tissue Research Facility (BTRF) d nt accmmdate many clinical trial visits which many times are cmpleted after nrmal wrking hurs Human Resurces Hiring prcess fr CRCs smetimes prevents the hiring f the best candidate in a timely manner Prcess requires that the hiring department pst a psitin fr a certain CRC level. There are times that the candidate pl at that level is sparse s the hiring department decides that it wuld be in their best interest t hire a different level. Hwever, t d s requires a fairly lengthy HR prcess, which means the hiring department either waits ut the prcess r hires a candidate wh may nt be their first chice. Opprtunities Assuming the rle f the crdinating center fr multi-site trials Cllabratin with ther academic institutins n clinical research prjects Cllabratin with ther health care facilities n clinical research prjects Creatin f new relatinships acrss grunds, prviding pprtunities fr translatinal research prjects April 16, 2014 4
Drafted by SOM Clinical Research Crdinatrs Partnering with industry n new drug and/r device develpment prjects Listing UVa clinical trialists n the tp natinal registries used by Pharma t identify study sites Additinal central supprt fr administrative aspects f clinical research, such as (nt an allinclusive list): Prtcl writing IRB submissin Budget develpment Regulatry dcument cmpletin/management, e.g., 1572 cmpletin CV management Financial disclsure frms Spnsr invicing Implementatin f a clinical trial management system (CTMS) that spans pre-study t clse-ut activities f a study; a system that decreases redundancies in the current prcess. (A simple example: entering the title (and ther infrmatin) f the prtcl int the CTMS wuld enable ppulate the infrmatin t all frms required fr the study (e.g., IRB prtcl, 1572, gldenrd). CTMS shuld be fully integrated with the systems f all applicable cmmittees, ffice and services, such as (nt an all-inclusive list): IRB Grants and Cntracts (and Office f Spnsred Prgrams) Prtcl Review Cmmittee SOM CTO Radiatin Safety Cmmittee Cancer Center Data Safety Mnitring Cmmittee Patient Financial Services University Physicians Grup Epic Implementatin f an electrnic IRB submissin prcess Develpment f a launch pad within the SOM Clinical Trials Office fr the training f new Clinical Research Crdinatrs (CRCs). Cncept is t prvide new investigatrs with trained CRCs Creatin f a pl f Clinical Research Crdinatrs that culd be used n a temprary basis by clinical research staff Develpment f a research assistant psitin that culd perfrm specific tasks f a research prject under the supervisin f the primary CRC April 16, 2014 5
Drafted by SOM Clinical Research Crdinatrs Create a bridge between the University Human Resurce ffice and the Medical Center Human Resurce ffice Bridge the relatinship between Medical Center staff and research staff Imprvement f clinical care and clinical research crdinatin Intrductin and implementatin f Epic billing and registratin system t allw fr time f rdering clinical research billing Mre tp dwn supprt f clinical research Creatin f a clinical trial track fr clinical staff, prviding them with the necessary clinical research training and educatin as well as prviding an pprtunity t increase their invlvement in clinical research Additin f research beds in the Emily Curic Cancer Center, staffed by trained and qualified nclgy nurses. Threats Lack f (r limited and reduced) funding Threatens CRC psitins and prevents advancement (n mney t pay) Threatens number f clinical research prtcls that can be dne Ptentially threatens the quality f research cnducted Discnnect between the prmise f clinical research supprt by Medical Center administratin and reality at the grass rts level. The MC emplyees prviding patient care are t busy t prvide any additinal patient services required by a clinical trial. Limits the studies that can be dne at UVa Ptentially threatens data integrity Opening trials fr the sake f having available trials Increases administrative burden Decreases time f research staff t enrll int ther trials Ptentially threatens ur reputatin with spnsrs Opening trials that are impssible t cnduct (e.g., I/E criteria t restrictive, we dn t have a large enugh patient ppulatin, study prcedures nt cnducive t recruiting/retaining subjects) Increases administrative burden Decreases time f research staff t enrll int ther trials Ptentially threatens ur reputatin with spnsrs Inability t cmpete fr pharma trials with ther larger, mre metrplitan academic centers April 16, 2014 6