Organiser: Dr. Thomas Hartung (DE), Professor of Pharmacology and Toxicology, University of Konstanz, Germany & Johns Hopkins Bloomberg School of Public Health, Dept. of Environmental Health Sciences & Molecular Microbiology and Immunology. Co-organiser: Aidan Gilligan (IRL), Founder, CEO SciCom – Making Sense of Science & Euroscience.

Wednesday 27th July, 2016: 12h50 – 14h05
ESOF 2016 MANCHESTER

Session Abstract:

Independent clinical trials are fundamental to improving the results, safety and cost-effectiveness of our health care systems. Yet, the exorbitant costs and acceptance hurdles involved often limit their scope to new products i.e. they are profit-driven and industry-led. Money matters. Important clinical interventions, surgery, physiotherapy, rehabilitation, public health measures etc. are of less interest to commercial sponsors seeking the lucrative benefits of primarily drug and device authorisation. While investigator-driven studies now find some support in the US, EU and elsewhere, they just cannot match the resources available for commercial clinical trials.

Public and charitable funding is typically backing healthcare-orientated trials independently of manufacturers, but it is often much smaller in size and scope. Results matter. Where we do manage to get new evidence, it allows us to look back (often in anger) and ask how good was the pre-clinical research to start with? If evidence-based medicine is the health care imperative of the 21st century, why does it remain so difficult to generate the evidence base for pressing public health challenges? Are governments and institutions to blame? This session unites world authorities in clinical and public health advances to explain its key trial stages and examine what could and should change. With expertise on leading animal and human studies to end products, speakers will open a window into how clinical trials are actually conducted. They will make the case for greater international cooperation and standards. Above all, effective communication of the clinical and societal benefits must be better coordinated to citizens, patients, healthcare professionals, researchers, policy-makers and society as a whole.

Categories:

Fostering breakthrough science. Ensuring responsible research and innovation, aligned with the values, needs and expectations of society. Harnessing science and technology to growth, employment, economic success and personal well-being.

Scientific Theme:

Science in our cultures.

Relevance to Theme, Special Relevance to Audiences & Diversity Statement:

Clinical trials matter. More often than not, they are at the heart of breakthrough science. Nothing mimics humans better than humans themselves. Yet, few can question that money matters more. Private, industry-led funders have every right to invest where they see a maximum return. Nevertheless, ensuring responsible research and innovation, aligned with the values, needs and expectations of society calls for a rebalancing of clinical trial efforts where the most societal health impacts can be achieved. This session takes stock of today's clinical trials landscape addressing, in particular, how the effective communication of the clinical and societal benefits must be better coordinated to citizens, patients, healthcare professionals, researchers, policy-makers and society as a whole.


SESSION PRESENTATION DOWNLOADS: CLICK HERE

German Flag
Organiser
: Dr. Thomas Hartung (DE),
Professor of Pharmacology and Toxicology, University of Konstanz, Germany & Johns Hopkins Bloomberg School of Public Health, Dept. of Environmental Health Sciences & Molecular Microbiology and Immunology.

Irish Flag
Co-Organiser:
Aidan Gilligan (IRL),
Founder, CEO SciCom – Making Sense of Science & Euroscience.
South African Flag
Moderator:
Prof. Julian Kinderlerer (SA),
President, European Group on Ethics in Science & New Technologies; Professor of Intellectual Property Law, Cape Town University.

Indian Flag
Discussant:
Ms. Seema Kumar (IND),
Vice President, Innovation, Global Health & Science Policy Communication, Johnson & Johnson.

   

 


Presentation Title: Look Back in Anger? What Clinical Trials Tell Us About Pre-clinical Research

German Flag Speaker 1:
Dr. Thomas Hartung (DE),
Professor of Pharmacology and Toxicology, University of Konstanz, Germany & Johns Hopkins Bloomberg School of Public Health, Dept. of Environmental Health Sciences & Molecular Microbiology and Immunology.

Dr. Hartung is a global thought-leader in evidence-based toxicology, pharmacology, molecular microbiology and immunology. He is passionate about promoting greater understanding of our every-day drugs and chemicals, which have long been suspected of playing a role in the genesis of most disease.

Talk Description:

My presentation will examine toxicology as a prime example where regulatory decisions for products traded at $10 trillion per year are taken only on the basis of such testing. What are the best practices and pitfalls involved? Are we sorting out the wrong candidate substances? If tested today, would aspirin fail the preclinical stage? I will evidence that whenever we give a closer look to the outcome of clinical trials in a field such as stroke or septic shock, we see how limited the value of our preclinical models was. What does this tell us for areas where we have few or no clinical trials to correct?


Presentation Title: The Latest Clinical Trial Research on HIV/Aids

South African Flag Speaker 2:
Professor Thandi Mgwebi (SA),
Director of Research and Director of the South African Systems Analysis Centre (SASAC) at the University of the Western Cape (UWC).

Professor Thandi Mgwebi is Director of Research and Director of the South African Systems Analysis Centre (SASAC) at the University of the Western Cape (UWC), South Africa. Currently she is also co-chair of the World Sustainability Forum 2017, which is co-hosted by the University of Basel, Switzerland, Universities of Cape Town and Western Cape, South Africa. Prior to her appointment at UWC, she was a National Research Foundation Executive Director for Research Chairs and Centres of Excellence, a national flagship programme of the Department of Science and Technology (DST).

Talk Description:

My presentation will outline the latest breakthrough science via clinical trials happening anywhere in the world. The MRC houses the internationally acclaimed HIV Prevention Research Unit which has undertaken numerous clinical trials over the past 15 years. The Unit currently has six established clinical research sites in the greater Durban area which are approved by the National Institutes of Health’s Division of AIDS (DAIDS) and equipped to run large-scale clinical trials. The Unit was the only centre globally to test four out of five microbicide products in five Phase III and 3 Phase II/IIb advanced microbicides clinical trials. The excellent work produced by HPRU gave the National Institutes of Health (NIH) the confidence to award it one of the largest grants outside of the USA to undertake HIV prevention research. The MRC is also hosting the African secretariat of the European Developing Countries Clinical Trials Partnership (EDCTP) and is at the forefront of the global fight against infectious diseases.



Presentation Title:
Non-Commercial, Healthcare-Orientated Clinical Trials

Italian Flag Speaker 3:
Dr. Raffaella Ravinetto (IT),
Clinical Trials Unit, Institute of Tropical Medicine, Antwerp (ITM).

Dr. Ravinetto is in the Head of the Clinical Trials Unit at the Institute of Tropical Medicine (ITM) in Antwerp, Belgium, and the coordinator of a network of non-commercial research institutions from Africa, Asia and Latin America. She has a broad knowledge of the landscape of non-commercial clinical trials and has managed multiple studies, particularly in low- and middle-income countries.

Talk Description:

Non-commercial clinical trials, which depend on external funding and often involve multiple partners in large international consortia, have to overcome major legal, ethical and operational challenges to be able to deliver results, and this is particularly true for research conducted in low- and middle-income countries. I will highlight these challenges and ways forward through the experience of two recently completed clinical trials: an emergency evaluation of convalescent plasma as treatment of Ebola, and an independent evaluation of antimalarials in pregnant women in Africa.


PRESENTATION DOWNLOADS

• Dr. Raffaella Ravinetto: "Clinical Trial & Error - Why Narrowing The Resources Gap Matters"