| Monday 21 October |
| Plenary session | |
| Translating trial evidence into practice | Chair: John Simes, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| Welcome | Stephen Blamey, Department of Health and Ageing, Canberra, Australia |
| Clinical trials for evidence; past, present and future | Iain Chalmers, James Lind Library, United Kingdom |
| Concurrent sessions: invited speakers | |
| Challenges in a changing regulatory environment | Chair: Ray Parkin, Eli Lilly, Australia and Gemma Ritchie, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| The impact of privacy guidelines on clinical research | Helen Ormandy, AstraZeneca Pty Ltd, Sydney, Australia |
| Declaration of Helsinki 2000 and update on International Conference on Harmonisation (ICH) guidelines | Johan Karlberg, Clinical Trials Centre, University of Hong Kong |
| Subgroups, surrogates and single trials: the regulatory perspective | Bob Temple, US Food and Drug Administration, Rockville, MD, United States |
| Concurrent sessions: invited speakers | |
| Clinical trials design | Chairs: Elaine Beller, Queensland Clinical Trials Centre, University of Queensland, Australia and Paul Glasziou, School of Population Health, University of Queensland, Australia |
| The
pros and cons of equivalence trials |
Victor DeGruttola, Department of Statistics, Harvard School of Public Health, Boston United States |
| Design of cluster randomised trials | Judy Simpson, Department of Public Health and Community Medicine, University of Sydney, Australia |
| Challenges in the evaluation of diagnostic technologies | Les Irwig, Department of Public Health and Community Medicine, University of Sydney, Australia |
| Free paper session 1 | |
| Outcome measures and analysis methods | Chairs: Ian Marschner, Pfizer, Australia and Val Gebski, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| Effects on size and power of pre- and post-stratification in clinical trials with a survival outcome | Richard J Fisher, Peter MacCallum Cancer Institute, Melbourne, Australia |
| Trading off benefits and harms: advantages of a holistic and comprehensive approach to outcome measurement | Lisa M Askie, University of Sydney, Australia |
| Selective exclusion of treatment arms in multi-arm randomised clinical trials | Matthew G Law, National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia |
| Use
of missing-data methods for validation of surrogate outcomes in clinical
trials with substudies |
Sally Galbraith, University of New South Wales, Sydney, Australia |
| Assessment of risk measures for survivors of acute coronary syndromes | Gillian Heller, Macquarie University, Sydney, Australia |
| Free paper session 2 | |
| Participation in clinical trials | Chair: Anushka Patel, Institute of International Health, University of Sydney, Australia |
| Strategies for recruitment to RCTs: a systematic review of controlled trials and observational studies | Patrina HY Caldwell, the Children's Hospital, Sydney, Australia |
| Competitive recruitment in the ROSEY study | Allison Martin, National Centre for HIV Epidemiology and Clinical Research, Sydney, Australia |
| A randomised trial of the effects of an intensive communication strategy on recruitment to a large-scale trial | Helen M Monaghan, University of Sydney, Australia |
| A logistical challenge: facilitating clinical trials during operational deployment | Tracey L Carthew, Australian Army, Brisbane, Australia |
| Recruitment and retention strategies in large multicentre, international phase III studies with prolonged follow-up: the ESPRIT (Evaluation of subcutaneous proleukin in a randomised international trial) experience | Sarah L Pett, National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia |
| Plenary session |
|
| Ethical issues | Chair: David Celermajer |
| Current ethical dilemmas in clinical research | |
| Tuesday 22 October | |
| Plenary session | |
| New technologies | Chairs: Terry Nolan, School of Population Health, University of Melbourne, Australia and Tony Keech, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| New technologies: integration and impact in drug discovery and clinical development | Peter Shaw, Bristol-Myers Squibb, Pennington, NJ, United States |
| Use of internet based technologies for clinical trials research | Mike Conlon, University of Florida Health Science Centre, United States |
| Challenges
for clinical research design resulting from new technologies for biotechnical
measurement |
Victor DeGruttola, Department of Biostatistics, Harvard School of Public Health, Boston, United States |
| Invited speakers: concurrent sessions | |
| Frontiers in statistical methodology | Chairs: Victor DeGruttola, Department of Biostatistics, Harvard School of Public Health, Boston, United States and Richard Fisher, Peter MacCallam Cancer Institute, Melbourne, Australia |
| Survival plots for reporting results | Val Gebski and John Simes, NHMRC Clinical Trials Centre, University of Sydney Australia |
| Analysis of cluster randomised trials | Tim Dobbins, University of Sydney, Australia |
| Modelling health state transitions | Malcolm Hudson, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| Substudies and surrogate endpoints | Sally Galbraith, University of New South Wales, Sydney, Australia |
| Invited speakers: concurrent sessions | |
| New technologies: genetics | Chair: Terry Nolan, School of Population Health, University of Melbourne, Australia |
| Pharmacogenetic applications in clinical development | Peter Shaw, Bristol-Myers Squibb, Pennington, NJ, United States |
| Evaluating the efficacy and safety of human clinical trials involving gene therapy | Ron Trent, University of Sydney, Australia |
| Bioinformatics: the view from a medical research institute | Terry Speed, Australia |
| Invited speakers: concurrent sessions | |
| New technologies: information technology | Chairs: Mike Conlon, University of Florida Health Science Centre, United States and Pam Hrubey, Eli Lilly and Company, Indianapolis, IN, United States |
| How can hand-held electronic devices assist with trials | Lior Rauchberger, Medseed Pty Ltd, Melbourne, Australia |
| A time and a place for electronic data capture | Jeff Klofft, Phase Forward Corporation, Waltham, MA, United States |
| Protocol hypothesis testing system | Bruce Shadbolt, Centre for Advances in Epidemiology and Information Technology, Canberra Hospital, Canberra, Australia |
| Plans
for a national clinical trials data information network |
Paul Vlagsma, NHMRC Clinical Trials Centre, University of Sydney, Australia |
|
Forums on research strategies and priorities in clinical areas |
|
| Link to forums page | |
| Wednesday 23 October | |
| Invited speakers: concurrent sessions | |
| Combining trial evidence and ensuring quality | Chairs: Iain Chalmers, James Lind Library, United Kingdom and Bernie Towler, Department of Health and Aging, Canberra, Australia |
| Strategies for obtaining best quality evidence from individual trials | David Henry, School of Population Health, University of Newcastle, Australia |
| Prospective registration of all trials; minimising bias in systematic reviews | John Simes, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| Prospective meta-analysis or overviews | Tony Keech, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| The role of the journals and publications in improving quality of trial evidence | Richard Horton, the Lancet, United Kingdom |
| Invited speakers: concurrent sessions | |
| Practical issues in trial conduct | Chairs: Martin Stockler, NHMRC Clinical Trials Centre and Sydney Cancer Centre, Australia and Jackie Brighton, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| How would your trial stand up in court? | Peter Cashman, Maurice Blackburn Cashman, Sydney, Australia |
| Streamlining the ethical review process in multicentre, multinational research | Davina Ghersi, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| Use of an internet based data collection and trial management system: the ADVANCE trial | Bruce Neal, Institute for International Health, University of Sydney, Australia |
| Conducting trials in emerging regions | Johan Karlberg, Clinical Trials Centre, University of Hong Kong |
| Free paper session 3 | |
| Electronic data management | Chairs: Wendy Hague, NHMRC Clinical Trials Centre, University of Sydney, Australia and Bruce Neal, Institute for International Health, University of Sydney, Australia |
| Use of electronic media to coordinate an international clinical study | Rebekah L Puls, National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia |
| Development of a clinical trials database / management program | Fred J de Looze, University of Queensland, Brisbane, Australia |
| Easily updated webpage design via an Access database: the Australasian Leukaemia and Lymphoma Group (ALLG) experience | Janey M Stone, Peter MacCallum Cancer Institute, Melbourne, Australia |
| EDM, an integrated strategy to unleash the power of data | Pam Hrubey, Eli Lilly and company, Indianapolis, Indiana, United States |
| The
use of electronic data transfers to manage the Australian HIV Observational
Database (AHOD) |
Kathy Petoumenos, National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia |
| Free paper session 4 | |
| Trials In practice | Chairs: Johan Karlberg, Clinical Trials Centre, University of Hong Kong and Davina Ghersi, NHMRC Clinical Trials Centre, University of Sydney, Australia |
| Clinical trials in Aboriginal health | Peter M Morris, Menzies School of Health Research, Darwin, Australia |
| Lifestyle intervention trials unmasked: methodological Issues | Carolyn F Elley, University of Auckland, New Zealand |
| Adoptive immunotherapeutic clinical trial for Epstein-Barr virus associated lymphomas nested within a prospective cohort study in solid organ transplant recipients | Suzanne L Elliot, Queensland Institute of Medical Research, Brisbane, Australia |
| Selecting the best cancer trials to support: Cancer Trials NSW (CTN) | Marie A Malica, the Cancer Council NSW, Sydney, Australia |
| Clinical trial monitoring in Australia |
Jonathon E Rankin, Therapeutic Goods Administration, Canberra, Australia |
| Plenary session and debate | |
| Participation in clinical trials | Chair: Tony Keech |
| Role of the consumers | Sue Lockwood, Breast Cancer Action Group, Melbourne, Australia |
| Use of the internet for maximising trial participation | Mike Conlon, University of Florida Health Science Centre, Gainesville, FL, United States |
| Debate: 'that all patients should participate in a clinical trial (barring issues of safety and consent)' | Martin Tattersall, University of Sydney,
Australia Richard Horton, the Lancet, London, United Kingdom Harvey White, University of Auckland, New Zealand David Celermajer, University of Sydney, Australia |
| Plenary session |
|
| Setting the future research agenda | Chair: Norman Swan |
| Panel
discussion |
Stephen Blamey, Department of Health
and Ageing, Canberra, Australia Iain Chalmers, James Lind Library, UK Richard Horton, the Lancet, London, UK Bill Ketelbey, Pfizer, Sydney, Australia George Morstyn, Advisor to Amgen, Melbourne, Australia Sally Redman, Institute for Health Research, University of Sydney, Sydney, Australia John Simes, NHMRC Clinical Trials Centre, University of Sydney, Australia Bob Temple, US Food and Drug Administration, Rockville, MD, United States |
| NHMRC Clinical Trials Centre | 26 Junel 2003 |