Clinical trial activity in NSW 2004–08
Since 2004, the Cancer Institute NSW clinical trials program has provided resources and support for cancer trials in New South Wales.
Background
The funding of the Cancer Institute NSW clinical trials program
commenced under the first state-wide Cancer Plan 2004-2006 to
increase trial activity across NSW by providing dedicated resources
within funded clinical trial units. The program was expanded
under the Cancer Plan 2007-2010 to formalise the structure of a
trials network and provide further support at Area Health Service
(AHS) to facilitate a streamlining of trials administration
process, research ethics and governance approval process and
business process.
The clinical trials program is currently
valued at $5.6M per year.
A total of $20.2M has been spent on this program since funding
commenced in 2004.
Under the Cancer Plan 2007-2010 the program has been set the
goal of 10 per cent of new cancer patients on clinical trials by
2010. The NSW Cancer Trials Network currently provides
funding for a total of 55 Full Time Equivalent (FTE) Cancer Trials
Nurses and Data Managers, across 49 individual Clinical Trial Units
in NSW.
Methods
- Since the commencement of the program in 2004, funded clinical
trial units have reported activity for annual review and
analysis.
- Unique trials conducted across the state have been identified
and matched to clinical trial registry information (www.clinicaltrials.gov, www.anzctr.org.au)
- This analysis of activity has included all trials which follow
participants over time, including intervention and observational
trials.
- Surveys and retrospective studies such as audits have been
excluded from this analysis.
- Patient activity for each reported trial has been monitored
over time, with a review of new patients enrolled and total
patients active on trial.
- The number of trials open for recruitment and new patients
enrolled on trials has been mapped against incidence and mortality
for each tumour grouping.
Results
Patient enrolments, 2004-2008
There has been a continued increase in the number of
active trials over the funding period
from 251 in 2004 to 438 in 2008.
 |
Enrolments to trials, 2004-2008
Enrolments to trials have increased significantly since
the commencement of funding,
although there was a slight decrease in 2008.
 |
Patients active on trial, 2004-2008
Total patients on trial (enrolled and in follow up) has
increased significantly since 2004,
with 7,536 patients on trial in 2008.
 |
Active trials by tumour group
the upward trend in the number of trials active has been
demonstrated across most tumour groupings, with the highest numbers
of trials in breast cancer and the combined grouping of
haematological malignancies.
 |
Patient enrolments by tumour group
Enrolments to trials have not followed the same consistent
increases across all tumour groupings, with more cyclic activity
demonstrated within some groups, although the overall upward trend
has been seen.
 |
Proportion of enrolments against incidence by tumour group
Mapping cancer patient enrolments for 2008 against
incidence for each tumour group highlights groupings which are
under-represented by activity - most notably urogenital, upper GI
and unknown primary.
 |
Proportion of enrolments against mortality by tumour group
Mapping of enrolments against deaths further demonstrates
that tumour groups with high mortality are significantly
under-represented in trial participation.
 |
Discussion
- The upward trend in activity demonstrated in previous reporting
periods has continued within the program over the period of
2004-2008.
- A slight decrease was seen in the number of enrolments in 2008,
but further investigation has shown an impact of delays in the
start up of new trials following the implementation of the single
ethical review model in NSW, with a greater number of trials open
for recruitment in the second half of 2008.
- Since the commencement of funding, there has been a doubling of
patients enrolled on clinical trials, with a total of 6.1 per cent
of incident cases enrolled on trials in 2008 compared with 2.7 per
cent in 2004.
- A review of trials demonstrates approx 40 per cent are industry
sponsored, which has remained stable over the funding period.
- There has been some fluctuation in the proportion of
participants enrolled to industry trials, with approx 80 per cent
of enrolled to non-industry trials in 2008.
- Streamlining of clinical trial processes and administration
will be further developed with the awarding of additional grants
for Area Health Service (AHS) networks
- AHS Networks will focus on Area specific strategies to meet the
specific needs of their patient population and individual clinical
trial units.
- Strategies for further increases in activity will focus on
those areas currently under-represented compared with incidence and
mortality.
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