Adelaide-based health research ethics organisation Bellberry will host a major international congress on the Challenges of Early Crossover in Clinical Trial Design for Oncology on Wednesday 22 October.
The congress will discuss some of the ethical dilemmas seen in cancer trials, including access to new treatments for both research participants and later to the wider community.
Bellberry CEO Kylie Sproston said that an international panel of experts overseen by a scientific advisory committee would launch guidelines at a workshop chaired by Emeritus Professor Lloyd Sansom AO.
“We are extremely proud to be able to bring together 45 world-leading experts representing all the stakeholders,” Ms Sproston said. “Oncologists and heath consumer groups at the frontline of treatment and trials will sit alongside regulatory bodies and the health technology agencies, which are often the people who allow access to and fund new treatments.”
The ethical dilemma at the heart of the conference is that clinical trials often include a placebo group and a group that is taking the proposed new drug.
The participants have typically exhausted all other forms of treatment.
“Randomised clinical trials commonly are designed to test an hypothesis that one treatment is superior to another,” Professor Sansom said. “In oncology trials it is becoming more common for patients to be able to switch from the control arm to the test arm, if the test appears to have some benefit over the control.
“It becomes difficult to define whether the test therapy actually results in a survival benefit because the trial has now become unbalanced and a selection bias may be significant.
“Some studies specifically prohibit switching in order to determine the unbiased survival gain. As a consequence of these potentially conflicting ethical issues, in regard to individual patients and to the broader society, there are considerable challenges for patients, clinicians and regulatory and payer agencies.”
Several methodologies have been proposed to address the issue of data interpretation.
The congress will address the ethical and scientific issue of patient switching with the aim to develop an international statement on the issues and options for all the stakeholders. The meeting will be attended by international and national experts representing patients, ethicists, clinicians, regulators, payers, scientists and the pharmaceutical industry
Ms Sproston said that Bellberry was in a unique position as an independent health ethics funder to be able to host the conference:
“We are keen to share the vibrancy of the Australian research environment with the delegates.”
The Expert Panel:
The international expert panel includes representatives from the following organisations:
- Australian Government Department of Health
- CADTH - Canadian Agency for Drugs and Technologies in Health
- EMA - European Medicines Agency
- EUNetHTA - European Network of Health Technology Assessment
- Health Canada
- IQWiG- Institute for Quality and Efficiency in Health Care - Germany
- NHMRC - National Health and Medical Research Council
- NICE - National Institute for Health and Care Excellence
- PBAC - Pharmaceutical Benefits Advisory Committee
- PBS - Pharmaceutical Benefits Scheme
- TGA - Therapeutic Goods Administration
The workshop will result in the development of an agreed statement of good practice, guidelines on approaches and clear agreement on any required next steps, all of which will be presented and debated at the conference.
Bellberry Limited is a national, private not-for-profit organisation providing streamlined scientific and ethical review of human research projects across Australia. Bellberry was formed in 2004 to provide the first service of its type in Australia. Bellberry’s Human Research Ethics Committees review and, where appropriate, approve and monitor research projects being conducted within the private sector. The Committees are registered with the National Health and Medical Research Council (NHMRC) and comply with NHMRC guidelines to ensure that “all kinds of research involving or impacting on humans conform to the highest standards of ethical practice and academic integrity”. www.bellberry.com.au
Emeritus Professor Lloyd Sansom AO, Division of Health Sciences, University of South Australia - M: 0402893148 - E: [email protected]