Ontario Institute for Cancer Research wins bid to operate clinical trials network

Seeking consortium of funders

The Ontario Institute for Cancer Research (OICR) has been selected to lead a new cancer clinical trials network in a concerted bid to improve patient care by increasing the quality and integration of research. OICR won an internationally adjudicated competition held by the federally funded Canadian Partnership Against Cancer (CPAC) to establish a Canadian Cancer Clinical Trials Network (CCCTN). It is now tasked with developing a business plan to be implemented in Spring 2014.

The OICR will establish a coordinating centre for the network and put together a consortium of funders for its operation, estimated at $7 million to $10 million annually. In collaboration with its partners — the Network of Networks (N2) and the NCIC Clinical Trials Group —it will utilize its previously developed clinical trials framework and extensive national and international collaborative partners.

"We've already done a lot to improve clinical trials and put a lot of research infrastructure in place, including information systems," says Dr Janet Dancey, the scientific director and head of the coordinating centre and director of OICR's High Impact Clinical Trials Program. "We will be able to create a deeper and broader level of activity for clinical research and clinical trials."

In addition to linking and building upon existing clinical trials groups across Canada, the CCCTN will support clinical trials in the areas of ethics, regulatory, biospeciman collection and analysis and knowledge transfer.

The Canadian Cancer Research Alliance (CCRA) estimates that its 33 members (which include all major funding organizations), spent $536.1 million on cancer research in 2010, down slightly from $248 million in 2009 but well above the $400 million spent in 2005. The actual total is likely much higher as it includes most of the peer-review research from government and voluntary sources but excludes spending by industry and institution-specific funding from hospital foundations and research supported by private foundations.

In an October/11 report, the CCRA found that "the ability to conduct cancer clinical trials in Canada was under growing threat" due to a number of factors from a leveling off of patient enrolment and increasing trial complexity to an increasingly onerous regulatory environment and decreased institutional funding for personnel to conduct trials. Its number one recommendation was a call for the creation of a "pan-Canadian infrastructure program that supports cancer clinical trials".

"We hope (the network) will attract new money to this area of research and provide the human resource infrastructure to undertake these trials in Canada," says Robin Harkness, CCRA's executive director and a CPAC research specialist. "We've been successful with clinical trials in the past and academic-based trials are what the network is about … This is a great opportunity for Canada. With Janet (Dancey) in the lead, it's in good hands."

common tools and resources

In addition to developing enhanced treatment options and moving new approaches into the clinic more quickly, the network and coordinating centre will also aim to develop and implement common tools and resources to enhance both clinical trial quality and execution and provide support for personnel in treatment centres and hospitals to allow for a greater number of clinical trials.

When the CCRA conducted its study into cancer clinical trials, it looked to the UK's National Cancer Research Network as an example of best practices. Harkness says the CCCTN has many similar elements to the UK model, particularly its system for effective patient accrual.

"Clinical trials execution has become increasingly complex with more regulation and ethical considerations as well as an emphasis on data quality," says Dancey. "If we prove the system with academic clinical trials, that will improve the Canadian system and infrastructure and skill sets that are needed. We hope to attract industry if we can prove the system."

For OICR chair Dr Cal Stiller, the network and coordinating centre is just the latest example of the institute's influence in cancer research, with its origins stretching back to 2000 when the Ontario government invested $50 million to establish OICR's predecessor, the Ontario Cancer Research Network (R$, December 20/00). At that time, just 2% of cancer patients were enrolled in clinical trials — a relatively low rate of patient accrual.

"People were asking for new therapies and they were asking to get into clinical trials. OCRN was established to triple that and we achieved this. In fact we exceeded it," says Stiller, who credits then OCRN president and CEO, Dr Bob Phillips a driving force behind its early success.

"That laid the groundwork for Dancey to succeed in getting the national centre. If you look for verification for what has been done that has national impact and credibility, this is a confirmation of that," says Stiller, adding that the new initiative can only help to increase the funding for cancer research. "OICR has been a spectacular success … If a program is established that has demonstrable impact and measureable outcomes, those programs will result in net increases in investment. This network provides for efficiencies and more solid scientific outcomes."

Stiller credits Dr Elizabeth Eisenhauer for leading the charge to establish the new national centre and network. As the chair of the Research Advisory Group for CPAC and the director of the clinical trials group of the National Cancer Institute of Canada, Eisenhauer was instrumental in convincing the cancer research community to support their establishment.

"She's the brainchild. She deserves national acclaim for her work equal to the international recognition she already has," says Stiller.

Eisenhauer is a cancer researcher at Queen's Univ and has been associated with the Kingston ON-based NCIC Clinical Trials Group since 1982.

The single largest funder of cancer research in Canada is the Canadian Institute of Health Research, which boosted its investments in the field from $95.5 million in 2005 to $136.9 million in 2010. It is followed by OICR which ramped up its investments from $20 million to $50 million in the same time period. The Canada Foundation for Innovation is also a major player in cancer research, with 2010 spending of nearly $50 million, due largely to awards made under its Research Hospital Fund — Large Scale Institutional Endeavours.

OICR teams with Janssen

In related news, OICR has is teaming with Janssen Inc (a subsidiary of Johnson & Johnson) to find and test new biomarkers for identifying patients with hormone-resistant prostate cancer at high risk for disease progression. The project will be led by OICR's High Impact Clinical trials Program in collaboration with researchers in four Ontario municipalities. The biomarkers could lead to more personalized treatments and fewer side effects for prostate cancer patients and potentially spare many men from serious side effects associated with prostate cancer treatment. The project will employ next generation sequencing and evaluate new imaging probes.

R$