Present: Marianne Burke, Justine Dee, Nancy Gell, Kairn Kelley, Mike
Lamantia, Connie van Eeghen
Start Up:
1.
Nancy
explains it all: Clinical Trial Registration (with plenty of contributions from
everyone)
a. How it all
started: realizing that sometimes registration must be completed before a study
is started
b. Is it
necessary:
i.
Do you want to publish a clinical trial, generally not a
“pre/post” but usually a randomized study
ii.
Certainly if an interventional study
iii.
May be a condition of IRB approval
iv.
Reduces ethical bias and gives context to reviewers; also could
help inform patients but is not used
v.
Includes studies with and without external funding
c. How to:
i.
Website is helpful but find the right page: get a 4-page pdf to
help out (ask Nancy for link)
ii.
UVM does not have a central administrator for a PRS account; it
takes a few days to set up an individual account
iii.
Timing: per website, no later than 21 days after enrollment of 1st
patient
1. However, Annals
of Medicine requires registration before enrollment
2. Keep in mind
that the date of submission is not the same as the day of review/approval
3. Registration
may precede IRB approval
iv.
Note that some journals not only have strict registration
requirements but may require data sources, statistical analysis code, and even
grant or IRB original submission – concern for ethical research and reporting
is high
d. Strategies
i.
Check the journals’ requirements first (when planning the study)
ii.
First time through: 2 hours (plus updates and emails)
iii.
Although the website keeps track of date of last change, it
doesn’t track what was changed. Keep
track of all changes, by date.
e. Followed the
process of one of Mike’s earlier studies: RCT with 3 arms on an ED adult
patient follow up phone call study.
PubMed ID# 24673675. It can take several
months for approval but it is possible to ask for expedited review.
i.
Qualitative studies appear to take longer to approve than
quantitative
2.
Plan for Next Semester: TBD
3.
Next Workshop Meeting(s): Fridays, 1:00 p.m.
– 2:00 p.m., at Given
Courtyard South Level 4 until end of Aug.
a.
Aug 5: (no
Kairn, Justine) – CANCELLED; go to noon meeting to listen to Dr. Timothy Plante,
3rd floor GY
b.
Aug 12: Marianne’s
data cleaning process
c.
Aug 19: Mike
Lamantia’s draft editorial on functional decline in older adults after ED visit
d.
Aug 26: