Draft Programme - Cardiovascular Round Table (CRT)
Draft Programme - Cardiovascular Round Table (CRT)
Draft Programme - Cardiovascular Round Table (CRT)
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ESC <strong>Cardiovascular</strong> <strong>Round</strong> <strong>Table</strong><br />
16-17 October 2012 – SHERATON Francfort Airport<br />
ESC R & D Workshop<br />
“Health-related QoL as key outcome parameter in CV Medicine ”<br />
<strong>Draft</strong> <strong>Programme</strong><br />
DAY 1 – Chairpersons: ESC – Industry<br />
Stefan Anker (ESC) – Florian Turk (Industry)<br />
13:00 - 13:15 Welcome and Introductory remarks Stefan Anker<br />
Florian Turk<br />
13:15 - 13:45 Clinical Outcomes assessments / Patient reported outcomes<br />
(15min presentation + 15min discussion)<br />
Experts Opinions<br />
13:45 - 14:00 Clinical outcomes assessments to revive feasibililty of clinical trials in<br />
CV (5min presentation + 10 min discussion)<br />
14:00 - 14:20 Health –related quality of life to characterize risk/benefit of therapies<br />
(5min presentation + 15 min discussion)<br />
14:20 - 14:40 Health-related quality of life to inform product registration: FDA<br />
perspective (5min presentation + 15 min discussion)<br />
14:40 - 15:00 Health-related quality of life to inform product registration: EMA<br />
perspective (5min presentation + 15 min discussion)<br />
Ingela Wiklund<br />
Karl Swedberg (tbc)<br />
Martin Cowie<br />
John Powers (tbc)<br />
Mira Pavlovic (tbc)<br />
15:00 - 15:15 Coffee Break<br />
15:15 - 15:35 Health-related quality of life to inform disease management guidelines<br />
in the US<br />
(5min presentation + 15 min discussion)<br />
15:35 - 15:55 Health-related quality of life to inform disease management guidelines<br />
in the EU<br />
(5min presentation + 15 min discussion)<br />
15:55 - 16:15 Health-related quality of life to inform reimbursement/formulary listing<br />
(5min presentation + 15 min discussion)<br />
John Teerlink<br />
Kenneth Dickstein<br />
(tbc)<br />
Jaime Caro<br />
16:15 - 16:35 Statistical issues in interpreting HRQoL data Stuart Pocock (tbc)<br />
16:35 - 17:00 CONSORT initiative: implementation of HRQoL measures in RCTs Melanie Calvert<br />
DAY 1 – BREAKOUT 1<br />
17:00 –17:10 Scope of paper and expectations from the breakouts Stefan Anker<br />
Florian Turk<br />
17:10 –18:15 Group 1 : Role/benefit of HRQoL to characterize and demonstrate<br />
risk/benefit in CV (would include trial feasibility) (S. Anker)<br />
18:15 Meeting closure<br />
Group 2 : Role/benefit of HRQoL to inform registration, listing and<br />
disease management guidelines in CV (F. Turk)<br />
20:00 Dinner
ESC <strong>Cardiovascular</strong> <strong>Round</strong> <strong>Table</strong><br />
16-17 October 2012 – SHERATON Francfort Airport<br />
ESC R & D Workshop<br />
“Health-related QoL as key outcome parameter in CV Medicine ”<br />
<strong>Draft</strong> <strong>Programme</strong><br />
DAY 2 – Chairpersons: ESC – Industry<br />
Stefan Anker (ESC) – Florian Turk (Industry)<br />
Preliminary conclusions from Day 1<br />
08:00 – 08.05 Setting the scene for Day 2 Stefan Anker<br />
Florian Turk<br />
08:05 – 08:30 Report-back of initial recommendations from Group 1 Breakout 1<br />
(10min presentation + 15min discussion)<br />
TBD<br />
08:30 - 08:55 Report-back of initial recommendations from Group 2 Breakout 1<br />
(10min presentation + 15min discussion)<br />
TBD<br />
DAY 2 BREAKOUT 2<br />
After first feedback on the preliminary proposals of day 1 breakout groups, provide the groups with<br />
the opportunity to revise and finalize the proposals<br />
09:00 – 10:30 Group 1 : Role/benefit of HRQoL to characterize and demonstrate<br />
risk/benefit in CV (would include clinical trial feasibility)<br />
Group 2 : Role/benefit of HRQoL to inform registration, listing and disease<br />
management guidelines in CV<br />
10:30 – 10:45 Break<br />
10.45 – 11:15 Report-back of proposed conclusions for ESC paper by Group 1<br />
(10min presentation + 20 min discussion)<br />
TBD<br />
11:15 – 11:45 Report-back of proposed conclusions for ESC paper by Group 2<br />
(10min presentation + 20 min discussion)<br />
TBD<br />
11:45 – 12:00 Summary and next steps<br />
Lunch<br />
Stefan Anker<br />
Florian Turk
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