SOCRATES (Standard of Care Randomized Trials) and the need for big randomized data.
April 22, 2021
IDDI Webinar on the SOCRATES (Standard of Care Randomized Trials) MODEL
LEARN ON THE CHALLENGES AND OPPORTUNITIES OF THE MODEL IN TERMS OF ETHICS, REGULATORY AND STATISTICAL ISSUES
Thursday April 22, 2021:
09:00am-10:00am CET – 05:00pm – 06:00pm AEST –
Randomized controlled trials are an essential part in the advancement of health care. Yet many interventions we use in everyday practice are not based on reliable evidence of effectiveness, while other treatments which have good evidence of effectiveness are not routinely used, in part because the evidence may be considered not applicable to the real world. More comparative effectiveness studies have partly addressed this gap, but the number of randomized trials of standard of care is limited due to many barriers, and often observational studies have been used in the real world with significant shortcomings.
A major paradigm shift in the conduct of pragmatic randomized standard of care trials to address this challenge is proposed: the SOCRATES model. This platform trial contains 3 essential features. For any particular condition, where a randomized treatment can be considered, provided:
- There are at least 2 standard of care options available (recognized in evidence-based guidelines or protocols)
- Both doctor and patient have no clear preference for each SOC option
- The patient gives informed consent to receive either option and to have their de-identified follow-up information collected.
Ethics approval is obtained for the master protocol with the responsibility of identifying appropriate treatment options resting with the responsible clinician in consultation with their patient. Randomized evidence of standard of care options would be accumulated in ‘living evidence’ guidelines as well as becoming part of enhanced big data sets in the electronic medical record. The model poses both significant challenges and opportunities in terms of ethics, regulatory and statistical issues, which will be discussed. The ultimate goal is to envisage a future world where simple randomization could be much more routinely embedded into standard of care decisions.
During this webinar, the participant will:
- Be exposed to some of the challenges in getting reliable evidence for health care options from randomized trials and the greater reliance on observational data for many individualized decisions
- Hear about some practical approaches to more routinely embed randomization into standard of care options including the SOCRATES model.
- Participate in discussions about whether we can make some of these approaches more of a reality.
PROF JOHN SIMES AO
Founding Director of the NHMRC Clinical Trials Centre, University of Sydney: email@example.com
He is Founding Director of the NHMRC Clinical Trials Centre involved in over 120 clinical trials and 80,000 patients in cancer, caridiovascular disease and neonatal medicine. He is also Founding Director of Sydney Catalyst (which helps facilitate translational cancer research with 30 member institutions in Sydney and regional NSW); a practicing medical oncologist in neuro-oncology at Royal Prince Alfred Hospital and Chris O’Brien Lifehouse; and Professor of Clinical Epidemiology at the Faculty of Medicine, University of Sydney. He is also a senior principal research fellow of NHMRC.
He has served on many national and international clinical trials’ research committees including cancer, cardiovascular studies and neonatal trials. He has a major interest in growing clinical trial evidence relevant to clinical practice in all its aspects, from better trial design through to more effective translation
Everardo Saad, MD: Medical Director at the International Drug Development Institute (IDDI).
- He has nearly 20 years of experience in Medical Oncology and clinical-trial design.
- He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston.
- After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the estimation of endpoints, and the development of novel therapies for cancer patients.
Clinical trialists, statisticians, medical oncologists, immunologists, physicians, regulators, and other professionals involved in the design, conduct and analysis of clinical trials and in the application of trial results into practice.