University of Florida Health Cancer Center UFHCC Disease Site Group Charter
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1 University f Flrida Health Cancer Center UFHCC Disease Site Grup Charter Versin: 2.0 August 22, 2018
2 Table f Cntents Overview...2 Disease Site Grup Purpse...3 Disease Site Grup Structure...3 Membership Selectin...3 Meeting Agenda...4 Respnsibilities f the Lead/C-lead...5 Respnsibilities f CTO Supprt Staff...6 Versin 2.0; August 22,
3 Overview The University f Flrida Health Cancer Center (UFHCC) has develped a systematic and rganized prcess fr the review and cnduct f cancer-relevant clinical trials. This system supprts multi-level reviews f all trials t ensure they receive apprpriate cnsideratin in the areas f clinical apprpriateness, feasibility, and scientific merit as defined by the UFHCC. The cmmittees cmprising UFHCC s Research Oversight System (ROS) wrk tgether t prvide a cmplementary review, but each has a distinct, and clearly defined rle. The result f the varius reviews is that each clinical trial is evaluated fr its alignment with UFHCC verarching bjectives. The likelihd f successful cmpletin f each trial is maximized thrugh an assessment f its feasibility, pririty in the cntext f ptentially cmpeting trials, and scientific integrity. The UFHCC ROS cmpnents invlved in prtcl selectin and apprval include: Disease Site Grup (DSG): The charge t the UFHCC DSGs is t prvide an integrated, multidisciplinary apprach t guide in the selectin, priritizatin and cnduct f high quality cancer research studies. Each clinical DSG has at least ne designated clinical and research leader while the Cancer Ppulatin Sciences DSG has research c-leaders. The DSGs rutinely meet t review all new and nging studies under their purview. All new interventinal trials must be reviewed and apprved by the applicable grup f recrd prir t SRMC submissin (fr example, any clinical trials cnducted in breast cancer must be vetted thrugh the breast DSG). DSGs are respnsible fr ensuring that adequate resurces are available t cnduct the study. The spnsring DSG research leader must attest t the prjected annual accrual, allcatin f UFHCC Clinical Research Office (CRO) resurces, presence r absence f cmpeting studies, and verall endrsement f supprt frm the grup. In additin, the DSG leaders are respnsible fr evaluating the impact f prpsed study n the patient ppulatin at UF Health and/r the UFHCC catchment area. The DSG leadership cllectively engages with ne anther and with UFHCC leadership thrugh the UFHCC DSG Leadership Grup. This quarterly management grup is a critical wrking cmpnent f the ROS. Investigatr Initiated Trial Cncept Develpment Grup (CDG): The UFHCC has a pre-review prcess fr all cancer-relevant IITs categrized as interventinal treatment r therwise invlving investigatinal drugs, devices r medical prcedures. This review, perfrmed thrugh the CDG, is mandatry fr any IITs planning t utilize UFHCC CRO resurces including Prject Management Office (PMO) services, research crdinatr r data entry supprt, regulatry management, financial, r ther in-kind supprt. Cncepts nt meeting these specificatins are exempt frm this mandatry pre-review, but may request this service. The aims f this cmprehensive review are t 1) imprve the feasibility, scientific merit and ultimate success in cmpleting cancer-relevant IITs, 2) shrten the timeframe frm cncept apprval t prtcl activatin and 3) maximize staff and investigatr effrt in prtcl develpment. Feasibility Grup (FG): The UFHCC recgnizes that a cmmn barrier t successful trial cmpletin is inadequate resurce allcatin. As a steward f limited resurces, the UFHCC Feasibility Grup (FG) is respnsible fr reviewing r prviding feedback n the nn-scientific aspects f a study being cnsidered. The gal is t assist the PIs and DSGs in ensuring adequate institutinal, financial, persnnel and patient resurces are available. The UFHCC FG prvides this infrmatin as a required cmpnent f the UFHCC CRO-managed prtcl develpment and as a cnsultant t ther UFHCC investigatrs. The FG issues a recmmendatin f feasible r nn-feasible fr each study reviewed t supplement DSG decisin making. The FG is als invlved in crrective actin plan develpment fr all studies at risk fr clsure r being place n prbatin by the SRMC. Scientific Review and Mnitring Cmmittee (SRMC): SRMC prvides the critical review f scientific merit, methdlgy, and validity f statistical analyses f cancer-relevant studies prir t activatin. The cmmittee will ensure prper priritizatin f studies and the ability t mnitr all cancer-related studies fr expected prgress relating t accrual gals and perfrmance Versin 2.0; August 22,
4 standards. The SRMC als has the authrity and charge t clse any study nt meeting the expected accrual gals r trials that have becme bslete by new advances in the field and therefre whse scientific ratinale has becme superseded by clinical practice. Fr a prtcl t be reviewed by the SRMC, bth the spnsring DSG/RP and UFHCC FC (fr CTO managed prtcls nly) must prvide endrsement. Disease Site Grup Purpse The primary bjective f each DSG is t prvide an integrated, multidisciplinary apprach t guide the selectin and endrsement f high quality cancer clinical trials. Each DSG is charged with establishing pririties within the framewrk described belw. T meet these bjectives, the DSG and their members are respnsible fr: Cllabrating with UFHCC members and ther UFHCC Research Prgrams t develp areas f research with ptential impact in the field f study, Reviewing initial study cncepts fr UF investigatr-initiated trials (IITs), Review and endrsement f all new trials which are t be pened, with attentin t cmpeting trials and impact t the UFHCC catchment area, Onging review and internal priritizatin f interventinal studies, Perfrming nging review f the DSG s research prtfli, including a review f accrual rates and cntinued scientific merit fr existing trials, Optimizing ppulatin subgrup recruitment, including increasing bth gender and racial/ethnic diversity, with particular emphasis n the UFHCC catchment area, Maintaining a pririty list f pending and active prtcls fr their research prtfli. Disease Site Grup Structure Disease Site Grups have been frmed t supprt the prgrammatic deplyment f cancer-relevant clinical trials t the UFHCC catchment area and in cnjunctin with the UFHCC s destinatin cancer prgrams. The list f DSGs, alng with the UFHCC members serving as DSG leaders is maintained by UFHCC administratin. Membership Selectin The UFHCC Directr is respnsible fr apprval f the frmatin f each DSG. Each DSG is led by a physician team and includes a multidisciplinary membership rster. The DSG research leader is appinted by the UFHCC Assciate Directr fr Clinical Investigatin (ADCI) while the DSG clinical leader is appinted by the UFHCC Assciate Directr fr Medical Affairs. Leadership terms are fr three (3) years, renewable upn the Directr s reapprval. The remaining membership cnsists f disease-fcused (r fr CPS, thematically research-fcused) members and may include: Investigatrs (Physicians, Pharmacists, PhDs, etc.) - vting members, Other clinical staff invlved in the research (e.g. advanced practice prviders, nurses, trainees) nn-vting attendees, Clinical Research Office staff nn-vting attendees, Clinical Research Administratrs nn-vting attendees, Cancer Center Administratrs nn-vting attendees. Versin 2.0; August 22,
5 T ensure a multidisciplinary perspective, the DSG cmpsitin includes a breadth in discipline, including, but nt limited t persnnel frm the fllwing departments (as apprpriate): Basic Science, Medical Onclgy/Hematlgy, Pathlgy, Radiatin Onclgy, Radilgy, Interventinal Radilgy, Labratry Research, and Surgery. DSG membership rsters are maintained by the DSG leaders in cnjunctin with CTO supprt staff. DSGs are required t meet at least quarterly (in persn r virtually) t review new prject prpsals and the full prtfli f trials. Trials may als be reviewed n an ad hc basis between meetings as is necessary based n their pririty. Meeting Agenda LOI Review fr UFHCC Investigatr-Initiated Trials (IITs) At the UFHCC, the review f UF IITs is a multi-step prcess, including review f a prpsed cncept fllwed by subsequent review f the full prtcl assuming the cncept is apprved t mve frward with prtcl develpment. Cncept review is an imprtant step intended t reduce faculty and staff effrt in develping prtcls f lesser scientific merit r redundancies; therefre, investigatrs must first submit UFHCC IIT cncepts t the DSG fr cmment, review and endrsement. This review prvides an pprtunity fr the DSG t strengthen the prpsed research by ffering cnstructive feedback n the hypthesis, bjectives, research design cncepts, eligibility criteria, etc. IIT cncepts that are determined t be f scientific imprtance t the DSG, that d nt verlap with existing trials, and thse which can reasnably be expected t cmplete accrual within the desired time frame, may be endrsed and will be submitted t the UFHCC IIT CDG. Prtcl Endrsement The DSGs review ptential prtcls fr endrsement, taking int accunt their verall study prtfli, ptential cmpeting studies, patient ppulatin, and likelihd f successfully accruing patients t the trial. Imprtantly, the DSG is required t cnfirm the PI s assessment f the accrual gals and annual target enrllments. The DSG leaders are als respnsible fr ensuring that prpsed studies align with clinical wrkflws and that all endrsed studies have the ptential fr a meaningful impact n the patient ppulatins served by the UFHCC. This review prcess culminates with the submissin f a DSGendrsed prtcl t the SRMC. This endrsement is dcumented n the SRMC submissin frm by a signature by the spnsring DSG research leader r delegate. Any cnflicts with a currently apprved prtcl must be explained in detail at the time f the submissin. Nte: prtcl review by the UFHCC FG may als be required fr a study t be placed n the SRMC agenda. Prtcl reviews by the DSG and FG may ccur simultaneusly and endrsements are perfrmed independently but in cnjunctin with each ther. Priritizatin f Ptential Trials Each DSG reviews a list f active clinical trials t determine whether the prpsed study cmpetes with an existing trial. If a study is deemed t be in cmpetitin with an nging study, the DSG must determine whether 1) current accrual rates and the institutin s patient ppulatin justify keeping bth studies pen r 2) if any cmpeting study r studies shuld be clsed r are expected t clse befre the new trial is pened. Cmpeting studies at the UFHCC are nt allwed, with the exceptin f the fllwing: 1) early phase studies, 2) cmpeting studies demnstrating maximized accrual rates and/r are anticipated t cmplete accrual befre the new trial is pened, r 3) studies that d nt have cmpletely verlapping eligibility criteria. Adequate accrual rates vary depending n the target accrual fr each trial. All DSGs must priritize their prtfli f studies and any new r prpsed trials in accrdance with the UFHCC SRMC manual. In general, the highest pririty studies are UFHCC member IITs. Inclusin f Wmen and Minrities r Ppulatin Subgrup Recruitment Versin 2.0; August 22,
6 It is expected that wmen and members f minrity grups and their sub-ppulatins be included in all UFHCC clinical research prjects unless a clear and cmpelling justificatin is prvided indicating that inclusin is inapprpriate with respect t the health f the subjects r the purpse f the research. Accrual f wmen and minrities t interventinal treatment, interventinal nn-treatment and nninterventinal studies shuld be prprtinal t the patient ppulatin in the UFHCC's primary catchment area. DSGs are respnsible fr identifying pprtunities and strategies fr recruitment and retentin f wmen and minrities; peridic review f recruitment rates fr wmen and minrities will be cnducted t crrect any deficiencies that are nted. Regular Review f Research Prtfli and Trial Accrual Onging review f the research prtfli is the respnsibility f each DSG. This review shuld include accrual t their active trials as well as the analysis f cntinued scientific merit f nging studies. The DSGs must regularly discuss prtcls that are nt accruing as expected and preemptively make recmmendatins t address accrual issues. DSG self-crrectin is always preferred prir t review at SRMC. Cmmunicatin with ther UFHCC cmmittees The DSGs are respnsible fr prviding a crdinated respnse t any questins r cncerns raised by the ther cmmittees f the UFHCC, including the SRMC, the Data Integrity and Safety Cmmittee (DISC), the Feasibility Grup (FG) and the Investigatr Initiated Trial Cncept Develpment Grup (CDG), as is apprpriate r warranted. Respnsibilities f the Lead/C-lead Each DSG leader is respnsible fr ensuring the DSG functins effectively as utlined in this Charter. Specifically, they: Cntribute t the missin f NCI-designatin and high-quality cmprehensive cancer patient care; Supprt the integratin f multidisciplinary crdinated care and research as the culture in clinical practice; Participate in UFHCC prgrams representing the respective DSG interests (i.e., educatinal meetings, industry partner summits, research prgram meetings, DSG Leadership cmmittee meetings, etc.); Supprt and fster the training/educatinal needs f research staff assigned t the DSG; Chair each DSG meeting, ensure adequate investigatr representatin is present and that meeting minutes are generated and archived; Facilitate distributin f Cancer Center cmmunicatins t DSG members; Facilitate any ad hc meetings r cmmunicatins (i.e., by r telecnference) as needed. In additin t the abve general DSG leader respnsibilities, specific further respnsibilities include: Research Leader: Establishes and maintains a cmprehensive research prtfli that cvers the key diagnses seen within the DSG s and UFHCC s patient ppulatin (prtfli includes industry, IITs, and NCTN trials and emphasis n studies that serve the catchment area); Reviews and analyzes mnthly and annual accrual metrics fr the active trial prtfli; Oversees nging internal priritizatin f the study prtfli; Prvides signing authrity n behalf f DSG fr SRMC submissins; Versin 2.0; August 22,
7 Prvides mentrship t junir faculty in the DSG, esp. in the develpment f IITs and supprt the translatin f UF-based scientific discveries t the clinic; Arbitrates discussins regarding pririty f trials; Research leaders f clinical DSGs reprt t the Assciate Directr fr Clinical Investigatin. Clinical Leader: Serves n Netwrk Cancer Cmmittee and/r supprt and perfrm quality imprvement/quality assurance studies; Maintains Cmmissin n Cancer cmpliance with Tumr Bard meetings and dcumentatin; Supprts effrts t attain r maintain natinal external accreditatin f cancer prgram (e.g., Quality Onclgy Practice Initiative (QOPI), American Cllege f Radilgy (ACR), Natinal Accreditatin Prgram fr Breast Cancer (NAPBC), etc.); Clinical leaders f clinical DSGs reprt t the Assciate Directr fr Medical Affairs. Respnsibilities f CRO Supprt Staff Maintain membership rsters fr DSGs, Create and distribute agendas and materials t the DSG fr review, Recrd meeting attendance and meeting minutes, Prepare and rute DSG meeting decisins (including endrsements, disapprvals, and vluntary study clsure decisins) t the SRMC and ther cmmittees as needed, Maintain pririty lists fr wrkflw and patient accrual based n disease team discussins, Reprt up thrugh t the CRO Administrative Directr. Versin 2.0; August 22,
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