Clinical Trials in Cancer Medicine
Michael Findlay Professor of Oncology
Director, Cancer Trials New Zealand
What do patients think about clinical trials?
What our patients say
“Would you consider being involved in a clinical trial?” .
Yes
No
“If you’ve already been in a trial, would you be involved in another one?”
MAYBE YES
NO
“Would you travel to be in a trial?”
Yes Maybe No
YES a nd 10 % wo uld co nside r relo cating !
How many patients have been offered a trial?
• 29% of patients had been offered a trial
• Of those offered a trial – 65% went on to one
In patients with melanoma
• 66% of patients had been offered a trial
• Of those offered a trial – 86% went on to one
“Why would you go into a clinical trial and why wouldn’t you”
• Benefiting others (93%)
• Better treatment (67%)
• More scans and longer follow-up (52%)
• Fear of
randomisation (78%)
• Toxicity of
treatments (72%)
• Unspecified
future use of
tissue (33%)
What is a Clinical Trial?
A clinical trial that is properly planned and executed is a powerful experimental
technique for assessing the effectiveness of an intervention
Intervention = investigational medicinal product (active,
placebo, comparator), surgery, service or a device
• Pre-clinical studies
• Phase I
• Phase II
• Phase III
• Phase IV
What types of trials are there?
Why do we have clinical trials?
• Test new treatments in a carefully controlled way
• Provide new options for patients
• Foster innovation and objective thinking in the local healthcare workforce
• Improve the quality of care:
o finding new treatments
o Improving the general standard of the service
delivery staff and processes in a treatment centre
What do we need to run a clinical trial?
• Patients
• Clinical trials (questions)
• Trained Investigators with dedicated time
• Infrastructure
– Research-capable treatment sites – Site coordination centres
• Money
• What examples internationally can we
benchmark against?
How does New Zealand compare to other countries?
1999
270,000 registered cases of cancer in the UK
<3.5% of incident cases were taking part in clinical trials
2008
Hypothesis: increasing research activity might improve outcomes and reduce variability across England
National Cancer Research Network
Sources: Stead et al 2011; Moorcroft et al 2016
2014
Patients enrolled on a clinical trial from those treated (%) – Ontario, Canada
2 4 6 8 10 12 14
Not sustained
Clinical trial enrolment patterns
Lead
Author Sample
size Trial
unavailable Ineligible Did not
participate Participation rate
Lara 171 47% 8% 22% 23%
Javid 909 46% 14% 24% 16%
Klabunde 2,339 60% 16% 17% 7%
Begg 3,534 33% 33% 16% 16%
Hunter 44,156 69% 18% 14% 8%
Average 49% 18% 19% 14%
Infrastructure
????
Patient
factors Clinical factors
What are the barriers to
participation in clinical trials
Doctor
factors
“Do you think your department could run more trials?”
What our clinicians say
“What limits your centre?”
How do we identify and overcome these barriers?
• National study of all patients starting treatment in cancer centres and their satellites during a 6 month period
• Identify whether:
– There is a trial suitable for them at the site
if not then are there studies at other NZ sites
– Whether they were offered the trial and if not why not
e.g. lack of doctor or researcher time, not eligible, travel, etc
– Whether the patient accepted entry into the trial
If not why not
• Collect recruitment metrics
Infrastructure
????
Patient
factors Clinical factors
What are the barriers to
participation in clinical trials
Doctor
factors
Clinical Trials in Cancer Medicine
• What do patients think about clinical trials?
• What is a trial and what types of trials are there?
• Why do we have clinical trials?
• What do we need to run a clinical trial?
• How does New Zealand compare to other countries?
• What are the barriers to participation in clinical trials?
• How do we overcome these barriers?
Infrastructure
CTNZ
Cancer Trials New Zealand Wellington
CCDHB
Auckland
ADHB
Palmerston North
Hamilton
WDHB
Christchurch
CDHB
Dunedin
SDHB
‘Core’ funders +
donations Project funders
