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The Lewin Groups' PReview of A Guidance Document for Implementing Effective Cancer Clinical TrialsQQ m Presented by Allen Dobson, PhD Senior Vice President September 26, 2005 Summit IX on Cancer Clinical Trials&n58- Presentation OutlinegStudy Sponsor and Purpose Overview of Guidance Document Structure Methods Key Findings Questions Raised6Study Sponsor and Purpose <C-Change commissioned The Lewin Group and Lovett Collins Associates, LLC, to create an industry guidance document for conducting phase II and phase III cancer clinical trials The Lewin Group and Lovett Collins worked closely with The Summit to develop this document The document provides both public- and private-sector policy makers, cancer researchers, institutions, and trial funding sources with information regarding regulatory requirement, and guidance on the functional requirements and costs associated with conducting phase II and phase III cancer clinical trials(RThe guidance document: Survey findings, Literature review, and Elements of SuccessIntroduction: Understanding the Document Cancer Clinical Trials Elements of Success Regulations Clinical Trial Functional Requirements Staff Time and Labor Cost Benchmarks Clinical Trial Costs and Reimbursement Practices 3`Survey respondents reinforced the importance of the Elements of Success identified by The SummitaaThe Summit developed Cancer Clinical Trials: Elements of Success which included: Committed Staff Adequate Financial Resources Accessible Ancillary Services Respect for Subjects Sponsoring Institution Emphasis on Safe Patient Care Although surveyed sites were not given the list of Elements of Success, responses to questions often encompassed the elements defined by The Summit and noted that in terms of committed staff, the PI s commitment was critical to program success<RZZZR4mThe Lewin Group with Lovett Collins developed clinical trial functional requirements to structure the survey nnFunctional requirements include: Securing the Protocol Internal Study Feasibility Decision Process Institutional Review Board (IRB) Submission Legal/Financial Review and Contract Execution Site Approval Preparation for Study Execution Study Execution Data Review Study Close-out&!!5MFrom the survey results, staff time and labor cost benchmarks were calculatedeBased on the mock phase II and phase III protocols provided with the survey, we estimated the following information: Per subject hours 25th percentile, median, 75th percentile Labor cost 25th percentile, median, 75th percentile Percent of time per staff type for functional area completion Data were provided for both pre-subject enrollment and total studyu) )>Cu   > C']Conducted a detailed survey of clinical trial sites, provided sites with mock trial protocols^^BTechnical Advisory Panel (TAP) nominated sites, reviewed survey, and developed mock trial protocols Survey collected information on: Site organizational structure and characteristics Participation in cancer clinical trials Basic financial data Staff time from start-up to trial completion based on mock phase II and III trial protocols Mock protocols were used to create  apples to apples comparison across sites<xxNxN2#Fourteen sites completed the surveyThe TAP nominated over 40 cancer clinical trial sites, 14 sites completed the survey representing a 35% response rate Respondents included Community Clinical Oncology Program sites (CCOPs), comprehensive cancer centers, hospital-based practices and independent practices Eight sites reported being affiliated with an academic medical center (AMC) Respondent sites represented 6 of the 9 U.S. Census Bureau regions x.IRespondents provided information on each of nine defined functional stepsSurvey information was supplemented with national wage data and the literature review Clinical trial staff were assigned a salary provided by either the U.S. Bureau of Labor Statistics or Salary.com Information regarding non-labor expenses was collected directly by the survey (i.e., overhead costs) A literature review was conducted to supplement survey information and support survey results x/ Key FindingszGovernment-sponsored trials are under-funded Non-trial sources of revenue are often needed to support clinical trial activity. On average 29% of revenue originated from non-trial sources, e.g., donations, contributions, grants, investment income Selection of trials is important  choose trials to serve patient population with a mix of government and industry trials Open trials without subjects enrolled represent a significant burden because of high start-up costs with little or no start-up payment We found considerable inter-site variability in clinical trial costs>x>) 7Government-sponsored studies are generally under fundedConsistent with the literature, industry trials were found to be more research intensive than government trials Phase II industry trials have the highest reported cost per subject * 4Cancer clinical trial start-up costs are significantDepending on the phase and type of study, the median pre-subject enrollment cost for each site range from $5,360-$8,627 per trial (the 25th and 75th percentile ranges were $2,273-$16,669) Government studies do not provide  start-up payment Survey respondents reported that 63% of their open industry trials had subjects enrolled while 56% of their open government trials had subjects enrolledBx  + 'Average labor costs varied across sitesvLabor cost accounts for H" 72% of total study cost Effective staff utilization can decrease study cost Sites used higher level staff in completing government trials versus industry trials, The Guidance Document provides many answers& and raises some questionsGuidance document is useful for sites to benchmark their costs and staff times Costs will vary depending on sites specific organizational structure and labor market conditions Additional questions: What accounts for inter-site variability in labor requirements? 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H  0޽h ? ___PPT10i.\`+D='  = @B +}  0 $(  r  S  xD   r  S  hr   H  0޽h ? ___PPT10i.\pK+D='  = @B +[  0 rj (  r  S  xD   r  S \ hr7       0e0eA 1 ?1  H  0޽h ? ___PPT10i.\"f+D='  = @B +}  0  $(  r  S  xD   r  S  hr   H  0޽h ? ___PPT10i.\~+D='  = @B +  0 `(  X  C F3     S   L    H  0`j ? a(80___PPT10.ϾPgvr`@4<?2 )@'4+H0R>ü2`ܰ,71Oh+'0|U$0P \h    PReview of A Guidance Document for Implementing Effective Cancer Clinical Trialsstephanie.cameronQLEW Lewin Presentation 24Microsoft PowerPoint 4.0@ ^@`wy*@X\@ ÑTGSg  )'    """)))UUUMMMBBB999|PP3f333f3333f3ffffff3f̙3ff333f333333333f33333333f33f3ff3f3f3f3333f33̙33333f333333f3333f3ffffff3f33ff3f3f3f3fff3ffffffffff3ffff̙fff3fffff3fff333f3f3ff3ff33f̙̙3̙ff̙̙̙3f̙3f333f3333f3ffffff3f̙3f3f3f333f3333f3ffffff3f̙3f3ffffffffff!___wwwff4'A x(xKʦ """)))UUUMMMBBB999|PP3f3333f333ff3fffff3f3f̙f3333f3333333333f3333333f3f33ff3f3f3f3333f3333333f3̙33333f333ff3ffffff3f33f3ff3f3f3ffff3fffffffff3fffffff3f̙ffff3ff333f3ff33fff33f3ff̙3f3f3333f333ff3fffff̙̙3̙f̙̙̙3f̙3f3f3333f333ff3fffff3f3f̙3ffffffffff!___www@A@@ ¼@ @CllmrIm⼼@@@Irrm» @@˜mmmm⼼A@@mr@@mmr¼@AA@mI @ @ @ mA@@՜.+,0    mOn-screen ShowThe Lewin Groupd3_ Times New RomanArial Book AntiquaMonotype Sorts WingdingsQLEW Lewin PresentationQReview of A Guidance Document for Implementing Effective Cancer Clinical TrialsPresentation OutlineStudy Sponsor and Purpose SThe guidance document: Survey findings, Literature review, and Elements of SuccessaSurvey respondents reinforced the importance of the Elements of Success identified by The SummitnThe Lewin Group with Lovett Collins developed clinical trial functional requirements to structure the survey NFrom the survey results, staff time and labor cost benchmarks were calculated^Conducted a detailed survey of clinical trial sites, provided sites with mock trial protocols$Fourteen sites completed the surveyJRespondents provided information on each of nine defined functional steps Key Findings8Government-sponsored studies are generally under funded5Cancer clinical trial start-up costs are significant(Average labor costs varied across sitesFThe Guidance Document provides many answersand raises some questions  Fonts UsedDesign Template Slide Titles_0    !"#$%&'()*+,-./012456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)PictureseCurrent UserSummaryInformation(UPowerPoint Document(3DocumentSummaryInformation8