CTMC 2018 Residential Course

Transcription

1 NOTE: All times are in Eastern Monday 4:00pm 5:00 6:00pm 6:00 8:00pm Faculty Meeting (Faculty ONLY) Regency Ballroom Networking (Partner Representatives/Faculty/Trainees) Regency Ballroom Opening Dinner and Keynote (Robert Silbergleit) Regency Ballroom Tuesday 9:15 10:00am Introduction / Opening / Description of signing up for appointments / Encouragement to fill out evaluations as we go (Meurer) Terrace Ballroom Overview of Clinical Trials (Foster) Terrace Ballroom NINDS Clinical Trial Networks NeuroNEXT, SIREN, and StrokeNet Terrace Ballroom Design consideration for early phase trials of non pharmacological interventions (Patterson) Terrace Ballroom 10:00 10:15am 10:15 11:15am 11:15am 12:00pm 12:00 1:00pm 1:00 1:45pm Small group breakout sessions Each group meets to set project goals for residential course, discuss plan to meet with other faculty, go to specific office hours, etc. (see p. 4 for small group room assignments) Recruitment and Equity in Research (Grill) Terrace Ballroom Lunch Terrace Ballroom A Foundation Perspective on Clinical Trials (Kuldip Dave, PhD MJFF) Concurrent Biostats Session: What should your clinician know before talking to you about sample size? (Yeatts/Meurer/Panel) Regency Ballroom 1:45 2:15pm Being an effective consumer of preclinical research (Haubenberger/Galpern) Concurrent biostats session: Early Learn Phase Designs (Martin) Regency Ballroom 2:15 2:30pm 2:30 3:00pm IND IDE for Sponsor Investigators (Khatri/Silbergleit) Terrace Ballroom Concurrent Biostats session: Later Learn Phase Designs (Quintana) Regency Ballroom

2 Tuesday (contin.) 3:00 5:00pm Study Hall and Specific Office Hours (see p. 5 for office hours appointments) Biostats faculty should hold office hours with their small group biostats trainee (clinicians should sign up to talk to both biostats faculty and trainee). Biostats office hours can focus on sample size pm Biostats faculty and trainees ONLY will meet in a larger group to discuss goals for the course. Regency Ballroom 6:00pm Small group bonding dinners (A list of locations will be provided at the course.) Wednesday 9:15 9:45am Introduction/Opening (Meurer) Terrace Ballroom Combined Session Biomarkers and Outcome Measures (Shefner) Terrace Ballroom Rare Diseases (Quintana, with brief clinical intro from Gutmann) Terrace Ballroom Multiplicity (Detry) Terrace Ballroom Concurrent Biostats Session: Developing a statistical analysis plan for a clinical trial (Cheung/Durkalski) Regency Ballroom 9:45 10:00am 10:00 10:45am 10:45 11:15am 11:15am 12:00pm Case studies from NeuroNEXT (Foster/Coffey) Terrace Ballroom CDE/Patient Reported Outcome Measures (PROM) (Conwit/Gutmann) Terrace Ballroom Career Development Mechanisms at NINDS (Korn) Terrace Ballroom Concurrent Biostats Session: Introduction to Adaptive Designs (Viele) Regency Ballroom 12:00 1:00pm 1:00 2:00pm 1:00 430pm 2:00 3:00pm Lunch Terrace Ballroom Small Group out Sessions (see p. 4 for room assignments) Office hours with Steve Korn (The first three trainees can step away from their small group meeting.) (see p. 5 for office hours appointments) Biostats Things I Wish I Had Known When I Was Starting Out as a Clinical Trials Statistician (Coffey/Yeatts/Patterson) Terrace Ballroom

3 Wednesday (contin.) 2:00 4:00pm Overall office hours faculty and others will have time to meet with students. Consider also using some time blocks for work on your protocol. (see p. 5 for office hours appointments) Biostats faculty can have sample size sessions. Biostats faculty should hold office hours with their small group biostats trainee. 6:00pm AAN dinner Professional Autobiographies (Durkalski, Hartman and Woo) (Meet Joy in lobby at 5:45p to walk to Gandy Dancer) Karaoke to follow dinner Thursday 9:15 9:45am Introduction/Opening (Meurer) Terrace Ballroom IRB in neuroscience research (Lewis) Terrace Ballroom Statistical Plans/Objectives for Safety (Martin) Terrace Ballroom Basic Data Management and CRFs (Ecklund, Kearney Chase) Terrace Ballroom Concurrent Biostats: Statistical Monitoring of Clinical Trials (Foster) Regency Ballroom 9:45 10:15am 10:15 10:45am 10:45 11:15am Genetics in Clinical Trials (Woo) Terrace Ballroom Guidance and protocol papers Enhancing Transparency and Reproducibility (Meurer) Terrace Ballroom Data sharing and transparency (Yeatts) Terrace Ballroom 11:30am 12:30pm Small group internal meetings (determine who will report on small group progress) (see p. 4 for room assignments) 12:30 1:00pm Box lunch/study hall/organic additional meetings 1:00 2:30pm Group reports (to whole cohort) and next steps 9 min per group (timing strictly enforced) have the 5 groups with biostats trainees go first, and then have breakout with biostats faculty and trainees in last half. Terrace Ballroom 2:30 3:30pm Evaluations and beginning of transport to airport

4 Small Group out Room Assignments: 1 Terrace Ballroom (3 rd floor) 2 Dahlmann Boardroom (3 rd floor) 3 Dahlmann Boardroom (3 rd floor) 4 Andy Boardroom (3 rd floor) 5 Dennis Boardroom (3 rd floor) 6 Ben Boardroom (3 rd floor) 7 Regency Ballroom (2 nd floor) 8 Regency Ballroom (2 nd floor) 9 Huron Boardroom (2 nd floor) 10 Huron Boardroom (2 nd floor) CTMC 2018 Residential Course

5 2018 CTMC Residential Course: Office Hours Sign-Up Sheet TUESDAY Times Faculty Areas Clinicians Conwit NM / Safety / DSMB Hehir Washington Granit Trummer Ram Skolarus Behavioral Interventions Tolchin Gaston Choe Meurer Stroke / Emergency / Design Ram Patel Al Kasab Grill Recruitment / Dementia Freitas Shinozaki Cho Lewis Emergency / Design Mistry Gutmann NM / Biomarkers Chew Hehir Patel Piquet Fisher Shefner NM / Outcome Measures Granit Chew Shinozaki Chahin Hartman Epilepsy / Peds Fisher Tolchin Silbergleit Ethics / Epilepsy / Emergency Al Kasab Haubenberger Movement Ali Hiller Galpern Drug Development / Mov d/o Trummer Stephen Khatri Stroke / Networks Chahin Barsan Emergency / Networks Layne Woo Genetics / Stroke Washington Silverstein Peds / Brain Injury Choe Research Professionals Kearney-Chase Logistics / recruitment Chahin Hiller Mistry Shinozaki Hehir Gaston Ecklund Logistics / recruitment Trummer Piquet Chew Navi Stephen Chahin Stevenson Logistics / budget Navi Ram Hehir Layne Alexander Shinozaki Harney Human subjects / emergency Patel Layne Navi Mistry Freitas Dome Logistics / behavioral int. Gaston Tolchin Alexander Stephen Washington Statisticians Yeatts Design / TBI / Stroke Choe Mistry Layne Barnes Navi Ram Martin Design / Stroke Al Kasab Patel Quintana Design / Rare diseases Stephen Piquet Ali Granit Barnes Detry Design / dose finding Barnes Cho Viele Design / historical controls Shinozaki Cho Coffey Design / networks Hiller Freitas Tolchin Hehir Piquet Granit Foster Design / networks Piquet Ali Freitas Fisher Cheung Design / CRM Alexander Ram Chew Patterson Design / Non-pharmacologic Alexander Choe Gaston Tolchin Cho Fisher Durkalski Design / Stroke Patel WEDNESDAY Faculty Areas Times Clinicians Korn Career Development Award Mistry Ram Alexander Stephen Piquet Tolchin Faculty Areas Times Clinicians Conwit NM / Safety / DSMB Choe Piquet Chew Meurer Stroke / Emergency / Design Mistry Navi Hehir Grill Recruitment / Dementia Washington Shinozaki Stephen Tolchin Ram Ali Lewis Emergency / Design Shinozak Gutmann NM / Biomarkers Granit Chahin Freitas Shefner NM / Outcome Measures Piquet Hartman Epilepsy / Peds Chew Silbergleit Ethics / Epilepsy / Emergency Patel Alexander Tolchin Haubenberger Movement Freitas Galpern Drug Development / Mov d/o Ali Freitas Tolchin Hiller XXXXXXXXXXXXXXXXXXXXXX Khatri Stroke / Networks Barsan Emergency / Networks Woo Genetics / Stroke Trummer Shinozaki Research Professionals Kearney-Chase Logistics / recruitment Alexander Choe Hiller Freitas Layne Patel Ecklund Logistics / recruitment Tolchin Alexander Granit Stevenson Logistics / budget Chew Mistry Piquet Harney Human subjects / emergency Stephen Tolchin Gaston Hiller Ali Fisher Dome Logistics / mobile health Fisher Shinozaki Granit Tolchin Spencer Statisticians Yeatts Design / TBI, Stroke Chahin Trummer Al Kasab Martin Design / Stroke Layne Mistry Stephen Quintana Design / Rare diseases Navi Gaston Chahin Detry Design / dose finding Mistry Granit Viele Design / historical controls Stats Faculty Will Be in Panel Discussion With Washington Coffey Design / networks Stats Trainees Foster Design / networks Cheung Design / CRM Cho Patterson Design / Non-pharmacologic Durkalski Design / Stroke Cho Washington