Conference Report: Clinical Drug Trials

Conference Report | 7 February 2017 | Download PDF

Clinical trials are at the core of fundamental decisions that are taken on a regular basis in the field of public health by regulatory authorities – such as marketing authorisation procedures.

For pharmaceutical companies, clinical trials are thus at the heart of fierce commercial interests as a marketing approval can represent huge money for its producer, said Patrick Durisch, Health Programme Coordinator at Public Eye, in his introductory remarks. As published literature extensively shows, clinical drug trials are subject to manipulation and biases, putting at risk not only the participants but also the population at large if the efficacy of the product is being overplayed or side-effects downsized, said Durisch. Concerns have also been raised about lack of transparency on trial results and unethical behaviour in the conduct of clinical trials.

Despite their importance, clinical trials as such are however rarely debated in public. To discuss these issues in depth and facilitate dialogue on the way forward, Health Action International (HAI) and Public Eye (former Berne Declaration) organised a public conference on 30 September 2016 in Geneva. The all day long event convened up to 100 participants from the NGO, regulatory, academia and industry sector. The session was divided in three keynote speeches and four panel sessions, which included short presentations from experts and an open debate between the panellists and the audience.

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Please find the agenda and presentation slides below.

Welcoming remarks
Welcoming remarks – Patrick Durisch, Health Policy, Public Eye

Keynote address
Keynote address – Tom Jefferson

Panel session 1 – Globalisation of clinical drug trials & ethics
The Environment of Clinical Trials in Egypt: And recommendations given to the Egyptian government – Ayman Sabae
Globalisation of clinical drugs trials: Who is benefitting and at what cost ? – Patrick Durisch
Developing world research ethics – Samia Hurst
Globalisation of clinical drug trials & ethics: the Swissmedic perspective – Françoise Jaquet

Panel session 2 – Transparency & access to clinical trial data
Transparency and access to clinical trial data Tom Jefferson
European Ombudsman – Jan Stadler
Clinical Trial Data Transparency: Making progress, but still a way to go – Ancel.la Santos Quintano
International Clinical Trials Registry Platform – Ghassan Karam

Keynote address
From regulators to co-developers? – Teresa Alves

Panel session 3 – Evidence generation for marketing authorisation & adaptive pathways
Adaptive Pathways: Concept and critical issues – Hans-Georg Eichler
Evidence generation for marketing authorisation & adaptive pathways: A HTA perspective – Beate Wieseler
Adaptive pathways Many questions – and a few answers– Jörg Schaaber
Adaptive Pathways: The consumers’ perspective – Mónica Cavagna
Clinical trials or no clinical trials: what about Adverse effects? – Sophie Le Pallec

Panel session 4 – The way forward for needs-driven public health research
Challenges of RCT – Silvio Garattini
The Way Forward for Needs-driven Public Health Research – Joel Lexchin
The Way Forward for Needs-driven Public Health Research – Katy Athersuch
The Way Forward for Needs-driven Public Health Research – Nathalie Strub-Wourgaft

Keynote address
Ruth Dreifuss

Closing remarks
Tim Reed

 


 

These events received funding under an operating grant from the European Union’s Health Programme (2014–2020).

 

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