Events

Workshop 2: Risk, Probability and Harm

16 April 2010, 10.30–17.30

Registration is not yet open.

There are at least two ways that risks demand our attention: by the probability of their materialising, and by how bad would be the harm if they did. But probability and harm are different kinds of concepts, and each is a focus of controversy, which working epidemiologists need to negotiate. Is probability a property of individuals (or can it be)? This view may be appealing in interpretations of quantum mechanics, where it is debatable whether 'hidden variables' can explain apparently probabilistic phenomena. But even if irreducible chances are the right interpretation of quantum mechanics, it is not obvious that the rationale will apply carry over to higher level sciences such as epidemiology, where the existence of hidden variables is beyond doubt. Maybe, then, the appropriate understanding of probability for epidemiology is purely statistical, reducing to average frequency in a specified population. But then it is not clear what basis we have for moving from the observed average frequencies on which our probability estimates are based, to the unobserved frequencies which (in practical applications) they estimate. The concept of harm bears more subtly but no less directly on epidemiology. For one thing, the kind of harm that epidemiology studies requires some thought, and is not necessarily dictated by clinical medicine. To take the obvious example, suicide is a public health concern, but never a clinical one (even if prevention of suicide may be). Moreover, the range of health conditions studied by epidemiology is increasing. The relation between harm and autonomy is also complex, and poorly articulated in the public health context. Whereas an individual smoker might be able to refuse clinical treatment for lung cancer, the population of smokers generally cannot avoid public health initiatives on smoking. And it is not clear how, if at all, their (various) desires can or should be taken into account when counting the cost of smoking to public health. Finally, there is a question as to whether risk is itself a kind of harm, so that exposing someone to an increased risk of lung cancer by passive smoking is harming them even if they do not in fact develop lung cancer. This relates in turn to legal questions about how causation is proved in toxic tort cases, where the correct presentation and interpretation of epidemiological evidence is of paramount importance.

http://www.hps.cam.ac.uk/epidemiology/workshop2.html

Venue: Royal College of Physicians, London

The event, called ‘Health for all, care for you’, is going to be the best place in Europe this spring to meet the leaders in the pharmaceutical industry, academic research labs and government regulators who are pioneering this field. The conference is organised around thought-provoking and interactive break-out meetings, peer-to-peer networking sessions, and exclusive plenary insights given by our speakers and discussion leaders. It will also include public release of a major, multi-country study of personalised medicine, conducted by researchers at Stockholm’s Karolinska Institutet.

Location: Montreal, Canada
REGISTRATION and HOTEL RESERVATION DEADLINE MARCH 22, 2010
 
Addressing the process, benefits and future of harmonization, the meeting will include a report on the first P3G harmonization process drawn on 50 studies from 18 countries. Challenges and opportunities in achieving the concrete harmonization of data and samples will be addressed and will lead to an action plan for finding practical solutions. Accordingly, the general focus of the meeting will illustrate the potential of pooling data and how this process can benefit biobankers around the world. By identifying and analyzing scientific questions and drawing on the harmonization platform, participants will be able to contribute to the next stage of progress in the harmonization process.

Venue: Crowne Plaza, Antwerp, Belgium

Medical research and drug development are focused typically on an adult population of patients frequently excluding, at one end of the age spectrum, children and, at the other, the elderly and frail. Reasons for these exclusions are multiple and are not the same for both populations, but typical hurdles are shared as e.g. ethical concerns about informed consent, the need for specific formulations, specific adaptations of protocol procedures etc.

Therefore these vulnerable populations are today unrepresented in research and drug development. Once a drug is on the market and used, clinicians, patients and caregivers have to base their treatment decisions on empiric data and dose assumptions and not on scientific valid data.

This lack of data was already identified in the past, but specifically only for children. Thus drug development regulatory bodies, academia, researchers and patients’ advocacy groups have recently agreed on improved and clear guidelines for research involving children. Much to be welcomed is the recently implemented, and in force in Europe since 2008, Paediatric Investigational Plan (PIP) for all new drugs in development.

At the other end of life, for the older and frail people, a lot of effort has still to be done as existing international recommendations and regulations are under review and the next steps to define what they will yield and how they will improve the situation are under discussion.

The European Forum for Good Clinical Practice (EFGCP) and The European CRO Federation (EUCROF) have thus brought together experts from both fields, experts in clinical research, ethics, social, patient organisations and pharmaceutical regulatory bodies to explore the shared ethical issues and to learn lessons from each other.

The objective of this workshop is to share concerns, to detect possible synergies and to learn from each other in order to improve and to facilitate and promulgate high quality ethical clinical research and drug development for these important populations across the whole of the European Union.

Max Perutz Lecture Theatre, MRC Centre, Hills Road, CAMBRIDGE

Please find below details of an event to officially launch the MRC Biostatistics Hub in Trials Methodology Research. The event will provide an introduction to the work that the MRC BSU HTMR is doing, detail how to initiate collaborations with us and provide an opportunity to meet with the MRC BSU-HTMR staff on an informal basis.

MRC BSU Hub in Trials Methodology Research Launch Event *Keynote speaker:* Professor David Spiegelhalter MRC BSU and Winton Professor of the Public Understanding of Risk

3:00-3:30: REGISTRATION AND COFFEE

3:30-3:45: Dr Adrian Mander, MRC BSU HTMR

"Introduction to the MRC Biostatistics Hub in Trials Methodology Research and the HTMR Network"

3:45-4:05: Professor Tim Eisen, Cambridge Cancer Trials Centre

"A groundswell of support for novel clinical trials - TIDAL1"

4:05-4:25: Professor Duncan Jodrell, CRUK Cambridge Research Institute

"Improving Early Phase Trial Design for Cancer Therapeutics"

4:25-4:45: Dr James Wason, MRC BSU HTMR

"Reducing the average number of patients needed in a phase II trial through novel designs"

4:45-5:15: TEA

5:15-5:45: Professor David Spiegelhalter, MRC BSU and Winton

Professor of the Public Understanding of Risk "Bayesian methods in clinical trials: has there been any progress?"

5:45-7:00: DRINKS RECEPTION