Research and Development workshops

Chairs: Paulus Kirchhof (ESC) and Stefan Schroeder (Bayer Healthcare)

Stethoscope

Objective:

There is an alarming need to address the lack of innonvation in the cardiovascular field.

Idea is to discuss alternative ways to conduct randomised controlled clinical trials and their methodology and to secure ways to encourage innovation.

Format:

Organisation of regular workshops, with participation from academic, industry and regulatory experts.
One of the expected outcomes of these workshops is the production of a written document, summarizing the issues addressed and the recommendations of the group, for publication in the European Heart Journal.

Timeframe:

Long-standing

Topics:

Topics are proposed by CRT members and validated during the CRT plenary meetings.

16/17 October 2012 -HRQoL workshop:

> See attached agenda.

The goals of the workshop are:

1. To compile and summarise the evidence for reduced health-related quality of life (HR-QoL) in different cardiovascular diseases such as coronary heart disease, atrial fibrillation, heart failure, and valvular heart disease from recent clinical trials and from registries, surveys, and market research sources.

2. To collect the information available at present on the effects of cardiovascular therapies on HR-QoL (e.g.the psychological / psychosocial effects of defibrillator therapy)and their relation between “hard outcomes” such as death, stroke, or myocardial infarction.

3. To review the recent FDA guidance for patient-related outcomes and the impact of that document for HRQoL, and the reasons for low inclusion of low HRQoL data capture in CV product development.

4. To propose a homogeneous set of parameters and suitable surrogates that need to be assessed to inform about HR-QoL in controlled trials in cardiovascular medicine.

5. Brainstorm initiatives to foster inclusion of HRQoL improvement in guidelines, practice, and product labels

Previous workshops

5 October 2010 - "Type 2 Diabetes and CVD" - London:

> See attached agenda.

The objective of this workshop was to inform the design of clinical trials concerned with the evaluation of the cardiovascular profile of therapeutic interventions for diabetes mellitus. This was informed by discussion on:

  • what is known about the CV impact of anti-hyperglycaemic therapies and other interventions
  • what CV outcomes effect can be expected from an anti-hyperglycaemic therapy and how this might best be disclosed.

12 & 13 May 2009 - "Secondary Prevention after ACS" + "Acute Heart Failure"

The CRT organised 2 successful think tanks with experts in related sub-specialties, to discuss the concept, methodology and design of clinical trials:“Acute Heart Failure” on 12 May 2009 and “Secondary Prevention after ACS” on 13 May 2009 in Paris.

The objective was to make a critical reappraisal of the way controlled trials are conducted in this area and make recommendations on how future trials might be conducted.

Participants were from the academic and R& D areas as well as members of the CRT and regulatory experts.

Written documents, summarizing the recommendations from the"AHF" and the "Secondary Prevention" workshops were submitted to the EHJ for publication.