SIG: Real-World Evidence (RWE) Collaborative

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  • 1.  Draft August 2021 minutes

    Posted 08-04-2021 10:56

    RWE Task Force: Methods Training

    Core Member Meeting

    August 2021 Minutes

    Quarterly at 9:00-10:00 EST / 14:00-15:00 UK / 23:00-24:00 JST


    Mission statement: Promote training in RWE methods to ISPE and non-ISPE members and key external stakeholders, in collaboration with the Education Committee.


    1. Roll call 

    Christopher 

    Rentsch

    x

    Joshua

    Gagne

    x

    Aziza

    Jamal-Allial

    x

    Caitlin

    Knox

    x

    Cathy

    Lerro

    x

    Hu

    Li

    x

    Ibrahim          

    Abdeldayem

    Jose

    Hernandez

    x

    Julie

    Lauffenburger

    Mai

    Vu

    Apol

    Marie

    Bradley

    x

    Masao

    Iwagami

    x

    Mina

    Tadrous

    x

    Ryan

    Seals

     

    Tatiane

    Ribeiro

    x

    Vicki

    Osborne

    Yasser

    Albogami

    Apol

    Amy

    Winter

      1. Approve last month's minutes
      2. COVID-19 RWE Textbook/Resource (CTR/Josh) 
        1. ISPE taking a larger editorial role in the entire RWE Resource
        2. Review draft outline of Chapter 2
        3. Please email CTR if you are interested in serving as sub-section author, and indicate your top 1 or 2 sub-sections you would be willing to lead
          1. What we want to be cautious of is recruiting too many individuals from a single company/institution. We decided that authors should be representative of sector, geography, gender, race/ethnicity, and that no more than 3 people from the same company/institution should be involved in the chapter overall.
          2. Need to independently lead in drafting a sub-section
          3. Deadlines to register interest: 
            1. 8 Aug: Email CTR to register interest
            2. 11 Aug: Josh, CTR, Donna, Almut to contact potential authors
        4. Deadlines for chapter
          1. Week of 9 Aug: Meetings with chapter authors and Editorial Committees (optional)
          2. TBD: Q3 Check-in call
          3. 24 Sep: First draft of chapters due from authors
          4. 27 Oct: Feedback on chapters back to authors
          5. 19 Nov: Final draft of chapters due from authors
        5. ACTION: Yasser suggested Ch 1 have discussion about checking/validating quality of RWD. CTR/Josh to propose this to Ch 1 authors.
    • ACTION: CTR share one pager and chapter 2 draft with the minutes (include Jeremy and Nicole separately)
    • Webinars (Josh/Aziza/Marie/Tatiane/Hu/Yasser/Education Comm)
        1. Audience: Targeted to a new audience such as 
          1. Pharma scientists
          2. Epidemiologists transitioning to pharmacoepi  
          3. PharmD/MD working on pharmacoepi research 
          4. External groups
        2. Webinar topic: compare and contrast real-world studies used for pharmacoepi research to traditional trials
          1. Introduction of various pharmacoepi methods such as propensity score, IPTW, etc 
          2. Define RWE/RWD studies and their data type
            1. RWE(based on healthcare data):
              1. Health claims
              2. Health records and EMR
              3. Registry
            2. RWD (based on more clinical evidence):
              1. PCT
              2. Case-control
              3. Case studies/reports
          3. How RWE/RWD research differs from traditional trials
            1. Methods
              1. Matching methods
              2. Randomization vs. propensity score
            2. Adjudications
            3. Data collection and database type:
              1. Healthcare database and administrative claims data 
            4. Limitation
              1. The trade-off between internal and external validity 
          4. Example of RWE/RWD study vs. traditional trials
        3. Flag any information from RWD Textbook that could be used in the Webinar
        4. Hu: Does ISPE have any existing material we could leverage when developing these webinars?
          1. Potential to reach out to course faculty who cover some of the topics to share/recycle materials
    • ACTION: Aziza to email subgroup and carry things forward
        1. RWE Expert Review Database (Yasser/Aziza/CTR/Membership Comm)
          1. Amy put to James Vrac
      • What information would journals like to see?
            1. Names, emails, affiliation(s), personal classifications
      • ACTION: CTR to have convo with Vin (PDS) and Hank (ACER) about what we want and how we can achieve that
      • PENDING ABOVE ACTION: Josh to review draft of email asking journals if they are interested and what information they would like in such a database
      • PENDING ABOVE ACTION: Reach out to one journal to figure out how to optimise and whether there is any interest
      • First stops: BMJ, Lancet HIV 
      • Ultimate goal: Lancet, NEJM
      • If journals seem keen…. Then Amy can survey ISPE membership to build database
          1. Include tick box acknowledgement that you can contact Amy to be removed from ISPE list, but you would need to contact journal directly to be removed from their rosters.
          2. If we have a list of journals who agree, then we can include selection of journals 
          3. ACTION PENDING JOURNAL KEENNESS: Amy to create survey to develop list of data elements for database 
        1. Future: checkbox on ISPE profiles? During conference sign up?
        2. Amy can maintain database and/or we can pass to Membership Committee
      1. RECORD-PE translation update (Tatiane)
        1. Currently being translated before sent to back translators at Equator UK
        2. Intended deadline: 31 Dec 2021
      2. Systematic review of COVID-19 RWE update (Tatiane/Mai/Jose/C19 subgroup)
        1. Ongoing
      3. AOB

      Actions

      • See above for more actions
      • Share the RWE deliverables sheet with group (ISPE Exchange and via email)


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      Christopher Rentsch MPH, PhD
      christopher.rentsch@lshtm.ac.uk
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