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O-October 1, 2004 dSummit VIII Peggy Devine CISN@pacbell.net5 0Summit IX on Clinical Trials Work Group 6 Report1x1  Robert B. Catalano, PharmD (Coalition of Cancer Cooperative Groups ) Peggy Devine, BS, C.L.S. (Cancer Information and Support Network) September 26, 2005 ''d Thank you WG6P6.1 Infrastructure & Funding (Recruiting chair) Bob Catalano, PharmD Nancy Roach, BS Jeanne Adler, RN Jo Ellen De Luca, BS Nancy Fredericks, MS Priscilla Banks Toni Kay Mangskau 6.2 Best Practices (Zelda Tetenbaum, chair) Jeff Belkora, PhD Peggy Devine, BS, C.L.S. Marg Good, RN,MPH,OCN Janine Kokal, RN Jane Perlmutter, PhD Suzanne Miller, MD Ron Myers, PhD Carolyn Valone Bell 6.3 Ethical Issues (Susan Samson, chair) Ann Fonfa Gwen Darien Margo Michaels, MPH Erica Heath Barbara LeStage Chris Takimoto, MD, PhD James Flory, PhD Shannon Marsh, JD Peggy McCarthy Rebecca Pentz, PhD Christine Grady, PhD ^1PP-PP*PPP1$#-3+'*   %  !  .         ?x % <4B ;e Background   fPatient Perspective: Overload  ]%Working Group Six SubGroup Structure*&   S +Statement of Problem WG 6.1 Infrastructure*,  8 How does it work now? Who writes the consent form? Who conducts the  consent process ? When do they conduct the process? Funding issues$"/2U2Preliminary Recommendations WG 6.1 Infrastructure63$$D  <Form In progress Process In Progress Training In Progress            V!Next Steps WG 6.1 Infrastructure*"   *   In Progress ^+Statement of Problem WG 6.2 Best Practices , D  NSystem is broken:  leaky Pipe Patient is vulnerable:  wobbly triangle - patient on the bottom Nature of the consent document: Insufficient attention to needs and role of patient Focus has been on liability of sponsors Protection (safety) of patient Deepen and broaden the  consent process B 4G)c 4   +  )_2Preliminary Recommendations WG 6.2 Best Practices 3 D  Form Move from informed consent to informed choice Reading level is maintained at 6th grade level Risk-benefits are spelled out clearly Process Decision aids are available for patient use Patient has neutral navigator and sufficient time Patient is aware of all options Training All conducting the process have training using best practice methods Navigator s are trained ZZZZZZ Z^Z         D  `"Next Steps WG 6.2 Best Practices"#  D   VDevelop template guidelines: Form: Better standard responses to NCI required categories Process: Better presentation of all choices (risks & benefits of all) Incorporate decision aids in some format Investigate motivational interviewing Training: Certified? Web-based standard trainings? Gather best practice examples Form Process TrainingZZ5Z ZZ Z)ZZZ5   (a#Statement of Problem WG 6.3 Ethics,$$D   Review literature and address critical issues: Efficacy of decision aides, particularly multimedia Multimedia presentations have potential but often fail to increase understanding Improved consent forms have shown mixed results in clinical trials Participants understanding of ability to drop out of study Retention of disclosed information Extended discussion has shown considerable promise for improving understanding Flory J, Emanuel E. Interventions to Improve Research Participants Understanding in Informed Consent for Research: A Systematic Review. JAMA. 2004; 292: 1593-1601.R/Z5ZZZ_ZQZZZ/5 " O"._ " =$$((,",00000000b)Preliminary Recommendations WG 6.3 Ethics** 8  Form Limitations of legalistic form Easily understood informed consent document Informed consent safeguards: risk benefit ratios Process Multiple interactions and discussions Importance of learning and coping styles Influence of form, layout, visuals, and interactive components More IRB attention to process, not just to form Training Investigator and CRA training Public understanding of clinical trials and complex scientific issuesZ~ZZZZ ZeZ~     e  cNext Steps WG 6.3 Ethics"  D   Assemble comprehensive listing of seminal articles Use tracking document Develop and refine  ethical checkpoints for conduct of informed consent processes, focus on: Form Process Training Finalize recommendations and draft report3_*3_* X 03Hg Thank you WG66.1 Infrastructure & Funding (Recruiting chair) Bob Catalano, PharmD Nancy Roach, BS Jeanne Adler, RN Jo Ellen De Luca, BS Nancy Fredericks, MS Priscilla Banks Toni Kay Mangskau 6.2 Best Practices (Zelda Tetenbaum, chair) Jeff Belkora, PhD Peggy Devine, BS, C.L.S. Marg Good, RN,MPH,OCN Janine Kokal, RN Jane Perlmutter, PhD Suzanne Miller, MD Ron Myers, PhD Carolyn Valone Bell 6.3 Ethical Issues (Susan Samson, chair) Ann Fonfa Gwen Darien Margo Michaels, MPH Erica Heath Barbara LeStage Chris Takimoto, MD, PhD James Flory, PhD Shannon Marsh, JD Peggy McCarthy Rebecca Pentz, PhD Christine Grady, PhD Please help us by filling in the WG6 questionnaire in your packet z1PP-PP*PPDP1$#-3+'*   %  !  .           C  ?y % <4B :_/P   0` 3ff` ` ___>?" dF@(?n2d@"u  FA@ " d`  n?" dd@   @@``PR    @ ` ` p>>L0  \@(    Nd gֳgֳ ?"`   T Click to edit Master title style! !<  H gֳgֳ ?"`   RClick to edit Master text styles Second level Third level Fourth level Fifth level!     S~  HgֳgֳA ?">T  `   "c:   BP gֳgֳ?" R 4 Moving from Informed Consent to Informed Choice b5xP0  B TgֳgֳA ?#" ? `n  Hfd޽h? ?"` 3fzҿ UCSF Logo 0 nfP ( K   B kk s$    x* J%%JJnnX   C  NG   (   Bd kk  K    RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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HBC?DExF^^}zvsolmjlVj '0:"A'I.P3X9_@eFhIlLnPqStVu[x^{a~ilpty~{xtqlhd^YSMG A:4.'!%(+16:=?j5j@` " B_C/DEF"_/_@`)B3 # BCDEHFR_drs[K__"Kw1-__&(@`') p8 $ BhCJDE\FfnuZA4*sFh ^F^lpIJ 2Snn04@`l@ % BC>DE8FBv>v>^__^ @`?`U & B^CDEF"^^@`P < ' B=CDE8FBw==w_^^_ @`H[ ( BC^DEF"^^@``IL E  )# E  * BCDE(F2 YZu={YYZ@`%  + B2C"DE0F: _eD2!~"Y q>w_@`1  , BCDE(F2 Uq" qI @`p   - ByCiDEF**m\CJN\uyY& $ IByyvbm[:=O\ipXF2 T "\dwVX@`E 8 . BA CrDE\Ff u|HP,AQA Q>k!r&`A  04@`H / H4 gֳgֳ;e ?5   Y276 patients seen by physicians P  0 H0 gֳgֳ;e ?5 9  b(14% accrual rate (39 patients enrolled))P)L E>  1# 5`u ~ 2 Ngֳgֳ ?E>  3 B_C/DEF"_/_@`gx 4 BCDEHFR_drs[K__"Kw1-__&(@`go @ 5 BhCJDE\FfnuZA4*sFh ^F^lpIJ 2Snn04@` v  6 BC>DE8FBv>v>^__^ @`7  7 B^CDEF"^^@`So  8 B=CDE8FBw==w_^^_ @`` 9 BC^DEF"^^@`{p@ : BA CrDE\Ff u|HP,AQA Q>k!r&`A  04@``_   ; N gֳgֳ ?u Illustrative data from Lara, P.N., Jr., et al., Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. 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