Cancer trial activity in NSW 2004–09
The Cancer Institute NSW clinical trials program was established in 2004 to provide funding for resources, infrastructure and staff to conduct cancer trials across NSW.
Baseline data shows there were 190 trials open for recruitment,
with 1,054 participants recruited to these trials in 2004. This
represented approximately 3.1 per cent of incident cases for that
year. The NSW investment in the clinical trials program was
provided with the aim of increasing annual recruitment rates to
trials against incidence rates.
In 2009 funding was additionally provided to seven Area Health
Services to established central Network Support Offices to
formalise the structure of the NSW Cancer Trials Network. The
program now funds the salaries of 53 FTE cancer trials nurses and
data managers in 44 trial units across the Network.
Strategies are being developed to better
select trials and identify opportunities to increase recruitment
rates across tumour groups, disciplines and under-represented
populations.
Funding for the program is provided by both Cancer Institute NSW
and the Cancer Council NSW, and is currently valued at $5.6M per
year. A total of $25.8M has been invested in the program since
2004.
Methods
- Since funding was first awarded in 2004, funded clinical trial
units have reported trial activity annually.
- The analysis of trial activity for NSW includes prospective
trials which follow participants over time, both interventional and
observational.
- Surveys and retrospective studies such as audits have been
excluded from this analysis.
- Unique trials reported by units have been identified and
matched to clinical trial registry information (www.clinicaltrials.gov,
www.anzctr.org.au).
- For each trial reported, the total number of new enrolments and
patients active on trial has been reported for each calendar
year.
- Average annual activity has been analysed by tumour group for
the period covering each NSW Cancer Plan; 2004-06 and 2007-09.
- Recruiting trials and new patients enrolled on trials have been
mapped against incidence and mortality by tumour grouping.
Results
Active trials per year
 |
There has been an increase in the number of active trials each
year from 251 in 2004 to 444 in 2009
Patients actively on trial by year
 |
The total number of patients active on trial has also increased
each year, with 8,194 patients active in 2009.
Patient enrolments by year
 |
Annual enrolment to trials has increased each year, from 1,054
in 2004 to 2,207 in 2009.
Patient enrolments by year
 |
Increases have been seen in the average annual recruitment to
trials in 2007-09 compared with 2004-06 in breast cancer and
colorectal cancers.
There has been a decrease in the average annual recruitment from
the 2004-06 reporting period in respiratory, upper GI and the
combined group of all types which are open to multiple cancer
types.
Comparison of cancer incidence to available
trials
Recruiting trials and new cases by tumour type
 |
Patient enrollment and new cases by tumour type
 |
Urogenital cancers, which as a group have the highest incidence
rate, were shown to have proportionally fewer trials available for
recruitment and subsequently a low proportion of patients
recruited. Recruitment to trials was also proportionally low for
respiratory, upper GI and gynaecological cancers, which have high
mortality rates.
Cancers with relatively good survival rates were well
represented with high numbers of patients enrolled on breast and
skin cancer trials over the reporting period.
Average Annual Enrolments 2004-06 % of Incidence
 |
Average Annual Enrolments 2007-09 % of Incidence
 |
The overall average annual recruitment for all cancers as a
proportion of new cancer cases has increased from 4.6 per cent in
2004-06 to 5.5 per cent in 2007-09.
In 2009 the total number of patients recruited to clinical
trials (2,207) represented 6.1 per cent of new incident cases.
Discussion
While an increasing trend has been demonstrated in the number of
trials available across all tumour groups for the reporting period
of 2004-09, the current review has highlighted a number of tumour
groups under-represented in activity when compared with their
burden of disease in terms of high incidence and/or high mortality
rates.
Haematological malignancies and breast cancer have had the
greatest number of recruiting trials over the reporting period,
while breast and skin cancers have had the greatest number of
enrolments. These groups (breast, haematology and skin) continue to
have relatively good five year survival rates along with strong,
well established co-operative groups with high recruitment
predominantly to industry-independent trials.
The greatest increase in recruitment to trials since 2004 has
been seen in colorectal cancer, from 126 patients in 2004 to 468 in
2009 with the majority of patients recruited to co-operative group
trials.
Respiratory and upper GI cancers have the highest mortality
rates, but continue to demonstrate proportionally low numbers of
recruiting trials and patient recruitment.
Further strategies are being developed to better select trials
and identify opportunities to increase recruitment rates across
tumour groups, disciplines and under-represented populations. The
commencement of the new NSW Cancer Plan
2011-15 in 2011 will implement a more strategic approach
to the recruitment of patients, with the development of a portfolio
of industry-independent clinical research studies on which grant
funded personnel will be required to work, exclusively.
Changes to the NSW Health system as a result of federal health
reform present some challenges, but also an opportunity to further
increase patient access to clinical trials by continuing to support
the Network structure and providing staff to manage and conduct
cancer trials across the state.
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