CER KFC Methods Meeting Summary_2_02_2012 v020512

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CER KFC Methods Meeting Summary_2_02_2012 v020512 Powered By Docstoc
					                                   CER Methods Workgroup monthly call agenda
                                        February 2nd, 2012, 3-4pm EST.
                                              Meeting Summary
Tunis, S., ( Co-Lead, CMTP) Filart, R., NCATS (NIH Coordinator); Fair, A., (PM C4); Brixner, D., (Utah); Carey, T., (
UNC-Chapel Hill); Collier , E., ( NIH); Concannon, T., (Tufts); Fang, H., (U Mass Med); Hayward, A., (NIH); Harrell,F.,
(Vanderbilt); Hlatky, M., (Stanford); Neumann, P., (Tufts); Ohlssen, P., (Novartis); Shapiro, M., (UCLA); Yu, C,. (

                                              Meeting Highlights
New CER KFC Methods WG Co-Leads
      Peter Neumann from Tufts and Jerry Krishnan from University of Illinois-Chicago were introduced as the new
        WG Co-leads joining Sean Tunis and Mark Helfand

  Presentation: Overview of the Bayesian DIA Group and CER Sub team by David Ohlssen, Novartis

         The Bayesian DIA group was formed last year and consists of 40 people comprised of industry, regulators and
         The aims of the group are to bring interaction to certain areas were Bayesian statistics might be helpful ( i.e, CER,
          safety assessment, joint modeling, program-wide decision making )
         Nine individuals in the CER subteam for the Bayesian group, others are welcome to participate. The aim of this
          subteam is to look at what Bayesian statistics can be useful in CER. Focus of are Bayesian statistical techniques,
          use of joint modeling of benefit risk assessment.
         There is a DIA CER group that runs in parallel with the DIA Bayesian group, this group is new and may also be of
          interest to the CER KFC Methods WG. The objective of the DIA CER group is to run training and conference
         Bayesian evidence synthesis techniques is a main focus of the DIA Bayesian group, with particular focus on
          medical product development and how it may be used in CER and also a niche focus on Bayesian evidence
          synthesis techniques in practice and engage with other people who will influence policy and decision makers.
         Second topic that the DIA Bayesian group is focusing on is use of joint modeling for benefit risk assessment; the
          objective is to look at how joint modeling for benefit risk assessment should be used in practice.
         Safety-meta-analyses links with both the DIA Bayesian and DIA CER sub-teams, the emphasis is on Bayesian
          techniques in safety-meta analysis will be used with evidence synthesis techniques. The FDA is writing the
          guidance in this area.
         External activities in the DIA Bayesian group, two conference upcoming one with the FDA industry workshop
          and the other at the Joint Statistical meeting, on the FDA/ Johns Hopkins applied partnership in comparative
          effectiveness ( PACES) initiative.
         The interaction with CER KFC Methods WG and the DIA Bayesian group is the first interaction documented
          between the DIA group and the CTSA.
         Chang Yu offered that within the CTSA there is a need for the ability to determine who is using similar CER
          strategies, particularly for the clinicians to compare treatment strategies beyond the traditional randomized clinical
         Chang Yu noted that work needed to be done to synthesize the work in CER for the CTSAs clinical
          colleagues/health care decision makers in order to answer some of the questions.
                        Once the questions have been posted by the decision-makers , tools using data analysis to answer
                           the questions need to be employed , the DIA Bayesian group is developing some of the tools to
                           answer the clinical questions.
         Chang Yu recommended that the CER KFC Methods BERD KFC groups and the DIA Bayesian group continue to
          interact together within the CTSA.
         Sean Tunis inquired about Bayesian approaches to evidence synthesis, what is in the DIA Bayesian domain,
          analyzing prospective clinical studies? Is it prospective data analysis or using pre-specified RCT data for
          secondary analysis? Analyses could be analysis of existing data but pre-specifying it in a new trial for secondary

Update on CB-PCTi: Presented by Sean Tunis, CMTP

      Develop concrete steps regarding this objective and continue to learn what other groups have going on in specific
       therapeutic areas and research networks.
      Need to sort out useful domains of people that want to contribute to CB-PCTi project and create a core group
       beyond the Co-leads to invest time and energy in the area of CB-PCTi.
      The three objectives of the CB-PCTi core group would be to
              Establish a robust, efficient national infrastructure for the conduct of community-based pragmatic clinical
                  trials building on the CTSA consortium platform and sustain this through a new public private
              Identify, prioritize and coordinate implementation of a portfolio of activities within and outside the
                  consortium that will establish and maintain the CB-PCTi.
              Develop a public-private partnership to sustain long-term efforts.
      This project which is now an aspirational/mega concept that needs to be carved into actionable subcomponents to
       improve clinical trials infrastructure nationally. There has been discussion on using ready to use capacity to do
       community/practice/primary care based real world trials.
      The RFA on Pragmatics Clinical Trials from NHLBI in CVD and pulmonary disease is just one example of how
       real world CB-PCTi will be used as a CER tool.
      The Helfand et al(2011) paper was referred to as a source to highlight the 3 critical needs/priorities of conducting
       a CB-PCTi
                        A CB-PCTi will allow the CER KFC Methods WG to improve methods for answering questions
                            about CER research using systematic reviews, public involvement and value of information to
                            determine research agendas.
                        CB-PCTi will form a sustainable platform for improving the design, conduct and analysis of
                            clinical research studies with a diversity of patients.
                        The CB-PCTi will create a bi-directional flow of information, rapid dissemination and sharing of
                            best practices to improve decision-making and linking the practice to the CER agenda.
      Chang Yu referred to the NEJM commentary article by Jim Weir on pragmatic trials that was conducted in
       England on Asthma and the need for more CB-PCTi trials. There is evidence that the level of interest in CB-PCTi
       is rising, however, there are a lot of barriers to getting the CB-PCTi done in the US, particularly combating
       statistical analysis issues. The challenges do not just stop with conducting CB-PCTis but also in statistical analysis
      Several workgroups in the IOM Forum on Drug Discovery and the FDA commissioner’s office are interested in
       community based PCAST.
                                  A report from PCAST (the President’s council on Science and Technology) which is
                                      doing a report on drug development. One of the findings on this report is the need for
                                      better access to infrastructure for phase 3, 4, and 4b clinical trials.
      Several groups have projects underway, DARTNet, MUSCLE ( Ken Saag at UAB), HMORN, CONCERT ( Jerry
       Krishnan, COPD project under CONCERT)
      In all four of these projects, people need to have in-kind resources to get projects funded in order to develop the
       infrastructure. This is a major challenge for core support to sustain the infrastructure.
      Sean posed a question to the group, Does a locus of strategic partnerships need to be made to better sustain the
       infrastructure over time?
      Tom Concannon suggested incubating infrastructures between investigators and ICs using the questions SGC4 is
       working with to link up with I/Cs and become a priority with SGC4.
      The incubation above would be illustrated by noting how investigator actions lead to the development proposal or
       collaborative relationship.
      Sean Tunis, discussed the bottom up approach where investigators projects and activities at the CER KFC
       Methods WG level can be the forum exchanging on lessons learned, best practices to move the CB-PCTi imitative
       forward .
        Sean noted the market demand for the ready to go CB-PCTi infrastructure and that is plausible based on the UK
         turning their entire national health services into a clinical research network. There is a report on how to do this
         and centralize efforts. On a national level the UK has gone a long way to have an infrastructure to do high level
         clinical trials at a lower cost.
        Sean inquired if the CER KFC Methods WG is the right forum for this initiative.
        Elaine Collier suggested that members look at two FOAs on Health Care Systems, Research Collaboratory : 1)
         Coordinating Center FOA RFA-RM-11-021 and the 2) FOA for Pragmatic Clinical Trials Demonstration Projects
         RFA-RM-12-002. The foci of this infrastructure are to bring together the methods, policies related to IRBs, data
         collections, defining patient phenotypes from EMRs and to develop a resource for information. The NIH is trying
         to address how to get the research done in real health care settings that needs to be done.
        Sean Tunis suggested doing things in a complimentary fashion leveraging relationships that exist in the CTSA
         towards this objective and go toward the national infrastructure more efficiently than funding individual
         investigators for smaller scale proof-of-concept projects.
        Frank Harrell noted there is not a lot of CTSA research going on related to CB-PCTi, there are not many pragmatic
         trials going on or RCTs in community settings. This is not to say that the CTSA platform cannot be moved in the
         direction of supporting CB-PCTis.
        Sean Tunis requested that members review the Next Steps slide and contact him at sean.tunis@cmtpnet.org if they
         are interested in the following next steps objectives 1) Establishing a planning committee ( less than 20 people) to
         draft a CB-PCTi startup plan and plan a F2F methods WG sponsored workshop for summer 2012, 2) Establish a
         steering committee to finalize workplan, time and task assignments for the summer 2012 F2F and 3) Be engaged
         in the Workshop in some capacity.

Action Items:
# Action Item                                                                    Responsible Party              Due Date
    Investigate piloting a public shared space where 18 or so Methods WG                                          Before
                                                                                    Alecia Fair, Rosemarie
1 members can enter their strengths/skills/experience in Methods for use by                                      March 22,
    the Methods WG                                                                                                 2012
    Outreach to collaborators and Inventory of PBRN colleagues in the
    consortium to add to the Methods WG existing list: Phil
                                                                                  Sean Tunis, Jeanne-Marie
2 Greenland,(SGC4); Wilson Pace (Co-Lead, CE PBRN), Paul Meissner,                                              Ongoing
    (Co-Lead CER DIR) Kurt Stangey (DartNet), Ken Saag (UAB), Dan Ford
    (Johns Hopkins)
    Continue to follow-up with David Ohlssen, DIA Bayesian Analysis group
3                                                                                            ALL                Ongoing
    at Novartis on reminder of scope of work for this WG
    CER KFC Methods WG members are encouraged to contact Sean Tunis
    sean.tunis@cmtpnet.org for their a) affirmative indication and interest
4 to continue the CB-PCTi discussion, b)interest to be on the CB-PCTi                        ALL                Ongoing
    planning committee c)interest in participating in the F2F workshop in
    summer of 2012 and in what specific issues to discuss
                                                                                     CER KFC Methods            Before
    Have a follow-up in a one-off discussion of the SGC4 priorities for the
5                                                                                  Leadership, Rosemarie        March 22nd,
                                                                                 Filart and Tom Concannon       2012
    Enlist support of the PBRN group at UNC-Chapel Hill for future Methods
6                                                                                         Tim Carey              February
    WG project on Pragmatic Clinical Trials
                                                                                                                 23, 2012

   Next Meeting Date & Time: Thursday February 23, 2012, from 12:00 PM -- 1:00 PM ET
   Recurring Meeting Date & Time: 4th Thursday of every month from 12:00 PM -- 1:00 PM ET


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