UPDATE (Sept. 28, 2023)! This joint seminar is now being held on Thursday, October 5, 2023 at 8:00 am in Botterell Hall, Room 143
Professor John Simes
Visiting Professor, Canadian Cancer Trials Group
University of Sydney
Medical Oncologist, Chris O’Brien Lifehouse and Royal Prince Alfred Hospital
“SOCRATES – Standard of Care Randomised Evaluation Studies and Improving Quality Health Care"
It is claimed that half of the health care decisions made each day are not based on randomised evidence of the effectiveness of treatments. There is a continuing reliance upon observational data and a call greater use of ‘big data’ to inform health care decisions partly due to the challenges of undertaking randomised trials.
The SOCRATES model is an attempt to make randomisation of Standard of Care options a much more routine part of assessing and providing quality care. The main features are to allow the clinician and patient to make a randomised choice of two or more SOC options when: i) these options are formally recognised as SOC in approved guidelines or protocols; ii) doctor and patient do not have a clear preference for each option and iii) the patient gives informed consent. Ethics approval for the overall platform but NOT each condition and SOC option is obtained.
A pilot study has been set up to test the feasibility of this approach in Sydney, Australia for a limited number of conditions and options initally – currently about 25 listed in an appendix to the study protocol. The aim is to recruit 200 participants either receiving randomised or chosen SOC options and assess patient experience, adherence and outcomes to allocated treatments and practicalites in patient follow-up and assessment.
The purpose of this session will be to outline the rationale for this pragmatic platform trial and steps to set up the pilot study and then have a discussion / debate about the many issues that it raises.
Points for discussion / debate.
- That this is a low risk trial since the risk to the patient is the same as if there treatment was chosen arbitrarily outside a trial.
- That the requiriements for data collection, adverse event reporting and follow-up are the same as for those receiving SOC outside a trial.
- That patient consent should largey mirror that when that is being sought for routine care.
- That while ethics and regulatory approval is appropraite for the overall platform, it should not be required for individual conditions or treatment options – provided the above criteria are met.
- That there are significant challenges in ensuring adequate numbers / evidence are obtained for each randomised question. How can we ensure this will reliably be added to evidence base for future health care?
BIO: Professor Simes, is a Senior Principal Research Fellow, National Health and Medical Research Council (NHMRC) and Senior Associate Director of the NHMRC Clinical Trials Centre, University of Sydney. He is a practicing medical oncologist at the Chris O’Brien Lifehouse and Royal Prince Alfred Hospital specialising in neuro-oncology. Prof Simes was Founding Director of the NHMRC Clinical Trials Centre (1988-2020) and is an international researcher in clinical trials, in cancer, cardiovascular disease, diabetes and neonatal medicine. He has played a lead role in many clinical trial initiatives internationally; is a clinical epidemiologist and medical oncologist with expertise in medical oncology, biostatistics and clinical trials research.
Professor Simes holds an NHMRC Program Grant entitled, ‘Better outcomes through innovations in clinical trials: from personalised medicine to population health’ and a new NHMRC Investigator Grant from 2022 to further this work. He has published over 400 peer-reviewed publications with >75,000 citations with major contributions to over 50 trials and multiple systematic reviews that have changed practice and shaped future clinical research.
Professor Simes’ work has been recognised through a number of awards including the NSW Premier’s Award for Outstanding Cancer Research (2016), the Harvard Alum Award (Biostatistics) from Harvard University (2009), the MOGA Cancer Achievement Award (2010) and the University of Sydney Vice-Chancellor’s Award for Outstanding Research (2017). Prof Simes was made an Officer of the Order of Australia in 2020.
Host: Christopher Booth, MD on behalf of Chris O'Callaghan, DVM, MSc, PhD