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.
- 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
|
|
- Approve last month's minutes
- COVID-19 RWE Textbook/Resource (CTR/Josh)
- ISPE taking a larger editorial role in the entire RWE Resource
- Review draft outline of Chapter 2
- 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
- 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.
- Need to independently lead in drafting a sub-section
- Deadlines to register interest:
- 8 Aug: Email CTR to register interest
- 11 Aug: Josh, CTR, Donna, Almut to contact potential authors
- Deadlines for chapter
- Week of 9 Aug: Meetings with chapter authors and Editorial Committees (optional)
- TBD: Q3 Check-in call
- 24 Sep: First draft of chapters due from authors
- 27 Oct: Feedback on chapters back to authors
- 19 Nov: Final draft of chapters due from authors
- 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)
- Audience: Targeted to a new audience such as
- Pharma scientists
- Epidemiologists transitioning to pharmacoepi
- PharmD/MD working on pharmacoepi research
- External groups
- Webinar topic: compare and contrast real-world studies used for pharmacoepi research to traditional trials
- Introduction of various pharmacoepi methods such as propensity score, IPTW, etc
- Define RWE/RWD studies and their data type
- RWE(based on healthcare data):
- Health claims
- Health records and EMR
- Registry
- RWD (based on more clinical evidence):
- PCT
- Case-control
- Case studies/reports
- How RWE/RWD research differs from traditional trials
- Methods
- Matching methods
- Randomization vs. propensity score
- Adjudications
- Data collection and database type:
- Healthcare database and administrative claims data
- Limitation
- The trade-off between internal and external validity
- Example of RWE/RWD study vs. traditional trials
- Flag any information from RWD Textbook that could be used in the Webinar
- Hu: Does ISPE have any existing material we could leverage when developing these webinars?
- 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
- RWE Expert Review Database (Yasser/Aziza/CTR/Membership Comm)
- Amy put to James Vrac
- What information would journals like to see?
- 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
- 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.
- If we have a list of journals who agree, then we can include selection of journals
- ACTION PENDING JOURNAL KEENNESS: Amy to create survey to develop list of data elements for database
- Future: checkbox on ISPE profiles? During conference sign up?
- Amy can maintain database and/or we can pass to Membership Committee
- RECORD-PE translation update (Tatiane)
- Currently being translated before sent to back translators at Equator UK
- Intended deadline: 31 Dec 2021
- Systematic review of COVID-19 RWE update (Tatiane/Mai/Jose/C19 subgroup)
- Ongoing
- AOB
Actions
- See above for more actions
- Share the RWE deliverables sheet with group (ISPE Exchange and via email)
------------------------------
Christopher Rentsch MPH, PhD
christopher.rentsch@lshtm.ac.uk------------------------------