Clinical Research Oriented Workshop (CROW) Meeting: Nov 7, 2019

Present:   Levi Bonnell, Justine Dee, Jen Oshita, Ben Littenberg, Liliane Savard, Adam Sprouse-Blum, Connie van Eeghen

1.                   Warm Up: Comps are a hypothetical study, not an actual study that will be moved forward now

2.                   How to do a comp:

a.       Identify the purpose of the study: feasibility or explanatory study or... prospective, randomized, parallel design

                                                   i.      A pilot is not a defined study; be careful about a vague description

                                                 ii.      Testing whether the intervention works as planned is a good use of a pilot study

                                               iii.      Decide what the research question is and build the case (proposal) around that; justify the choice of design

b.       Describe the intervention in simple terms, e.g. a manual, and whether it has been previously trialed

                                                   i.      Determine ahead that the manual is ready for effectiveness trial or needs more testing/refining

c.       Plan ahead for the feasibility of the proposal to the reviewer, e.g. assert that a pilot has already taken place with an effect size of x, or that a proof of concept trial took place, or that a previous trial produced a null outcome

                                                   i.      Be consistent: either a study has good enough numbers to move the field forward (use the numbers to support the grant) or not (don’t)

                                                 ii.      Be open about limitations on the population or characteristics of the study

d.       Example

                                                   i.      Determine the study: RCT

                                                 ii.      Support it with previous studies, trials, and their outcomes

                                               iii.      Use the required tools appropriately, e.g. power calculations

                                               iv.      Tell a clear story

e.       Suggestions:

                                                   i.      Clarify the intervention

                                                 ii.      Identify the hypothesis

                                               iii.      Assume that you know the effect size

                                               iv.      Simplify the story

3.                   Future sessions:  

a.       11/14: Adam

Recorded by: CvE