Clinical Research Oriented Workshop (CROW) Meeting: July 29, 2016

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 1^st 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, 3^rd 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:

Recorder: Connie van Eeghen