Summary
Programme will be coming soon.
Objective of the CRT meeting on:
1. Are PROMS/PREMS ready for use as primary outcome measures in regulatory CVD Clinical Trials (for approving drugs and/or devices) and what are the ethical premises for doing so?
2. How should we set up a system to systematically identify UMN in CVDs from PROMS/PREMS - patients' perspective and how should we involve patients in horizon scanning of new technologies based on this concept?
3. What should be the role of patients in the risk - benefit assessment system in regulatory trials to stimulate innovation/ensure safety and how should we balance between PREMS/PROMS, traditional efficacy and safety measures?
Draft Programme
Academic Chairpersons
- Prof. Lis Neubeck
- Prof. Piotr Szymanski
- Prof. Cecilia Linde (ESC President-Elect and ESC Chair of the CRT)
Industry Chairpersons
- Dr. Maria Ripa/Novo Nordisk
- Dr. Prodromos Anthopoulos/Cytokinetics
- Prof. Alexandra Goncalves /(BMS) (Industry Chair of the CRT)
Day 1: 19 February 2025 13:30–18:30 CEST
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Time |
Session |
Speaker |
|---|---|---|
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12:00-13:30 |
Arrival and Buffet Lunch |
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13:30-13:35 |
Welcome from the CRT Chairpersons |
Alexandra Goncalves (BMS) Cecilia Linde |
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13:35-15:30 |
SESSION 1.1 – METHODOLOGICAL SECTION: PROMS/PREMS- identifying unmet medical needs Moderated by: Piotr Szymanski and Maria Ripa (Novo Nordisk) |
|
|
13:35-13:55 |
Definition of PROMS/PREMS (methodology to dev, geographical specificities, medical devices particularities, links between PROMS/PREMs and UMN …) |
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13:55-14:15 |
Current perspectives of using PROMS/PREMS as primary end points for regulatory approval of drugs |
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|
14:15-14:35 |
Patient perspectives of using PROMS/PREMS as primary versus supportive end-points in the approval of new drugs and devices |
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14:35-15:00 |
PANEL DISCUSSION |
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|
15:00-15:30 |
Coffee Break |
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15:30-18:30 |
SESSION 1.2 – TRIAL SECTION: designing clinical trials Moderated by: Lis Neubeck and Mr. Prodromos Panthopoulos (Cytokinetics) |
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15:30-15:50 |
Patients’ role in the design and monitoring of clinical trials – perspective from a trialist |
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15:50-16:10 |
Patients’ role in drug development - perspective from the industry |
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16:10-16:30 |
Patients’ role in the appraisal of clinical trial results and development of Guidelines documents – perspective from the patient |
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16:30-17:20 |
BREAKOUT SESSIONS: Designing clinical trials |
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Group 1: Are PROMS/PREMS ready to use as primary end points in clinical trials? |
Lead: TBD Rapporteur: TBD |
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Group 2: How to overcome current limitations of PROMS/PREMS? |
Lead: TBD Rapporteur: TBD |
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Group 3: The role of new technologies in the assessment of PROMS/PREMS |
Lead: TBD Rapporteur: TBD |
|
17:20-17:30 |
Coffee Break |
|
|
17:30-17:40 |
Report from breakout session 1 |
Rapporteur: TBD |
|
17:40-17:50 |
Report from breakout session 2 |
Rapporteur: TBD |
|
17:50-18:00 |
Report from breakout session 3 |
Rapporteur: TBD |
|
18:00-18:25 |
PANEL DISCUSSION |
|
|
18:25-18:30 |
Wrap-up and Summary Day 1 – Outlook to Day 2 |
Alexandra Goncalves (BMS) Cecilia Linde |
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END OF DAY 1 |
||
|
19:30 |
APERITIF + DINNER |
|
Day 2: 20 February 2025 08:30–12:30 CEST
|
Time |
Session |
Speaker |
|---|---|---|
|
08:30-08:40 |
Summary of day 1 |
|
|
08:40-09:50 |
SESSION 2.1: Risk Benefit Assessment Moderated by: |
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08:40-09:00 |
Statistical and practical reliability/validity of clinical trial results |
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|
09:00-09:20 |
Who and how should assess risks and benefits of innovative technologies before their approval? |
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09:20-09:40 |
The role of patients in the early feasibility studies |
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09:40-10:20 |
BREAKOUT SESSIONS: Risk Benefit Assessment | |
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Group 4: Should patients take the leading role in the risk-benefit assessment of new technologies before their approval? |
Lead: TBD Rapporteur: |
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Group 5: Who and how should educate patients (which patients) to enable them taking their roles in the design and appraisal of clinical trials? |
Lead: Rapporteur: |
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Group 6: How should patients be involved in the regulatory process? |
Lead: Rapporteur: TBD |
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10:20-10:40 |
Coffee Break |
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10:40-10:50 |
Report from breakout session 4 |
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|
10:50-11:00 |
Report from breakout session 5 |
Rapporteur: |
|
11:00-11:10 |
Report from breakout session 6 |
Rapporteur: TBD |
|
11:10-12:40 |
SESSION 2.2: Future directions and shared vision for addressing the unmet needs. Moderated by: |
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11:10-11:30 |
The use of PROMS/PREMS in health technology assessment / in cost effectiveness assessment. |
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11:30-11:50 |
Reflection in product information (drugs) |
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11:50-12:10 |
Future definitions of Unmet medical needs |
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12:10-12:35 |
PANEL DISCUSSION and NEXT STEPS |
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12:35-12:40 |
Wrap-up, conclusions |
Alexandra Goncalves (BMS) Cecilia Linde |
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END OF DAY 2 |
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12:40 |
Buffet Lunch and Departures |
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Biographies
Coming soon
Our mission: To reduce the burden of cardiovascular disease.