Cancer trial activity in NSW 2004–09

Research updates

Issue 6, December 2010

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.