Ontario's Clinical Trials professionals reflect on progress and plan for future at annual meeting

In March, the Ontario Institute for Cancer Research (OICR) Clinical Trials Program invited clinical trials professionals to discuss progress on major changes that are helping bring new treatments to patients sooner.

Each year, OICR invites clinical trials professionals to a day-long Clinical Trials Programs Annual meeting to discuss the Institute’s clinical trials strategies and seek feedback on its Clinical Trials Programs. The professionals who attend consist of physicians, nurses, managers and key decision makers in the health care system that specializes in cancer clinical trials. This year’s meeting included 72 participants representing 25 cancer centres and community hospitals in Ontario.

Clinical trials bring the benefits of research to patients, allowing new treatments to be used in the health care system. The studies are often led by Ontario-based principal investigators and reviewed by research ethics boards. In 2002, research by OICR’s predecessor, the Ontario Cancer Research Network (OCRN), identified significant barriers to getting clinical trials for new cancer therapies up and running. The barriers included personnel shortages, budgeting issues, lack of affordable education opportunities for clinical trials personnel and administrative delays in the contract negotiation as well as in the research ethics review process.

OCRN launched a number of programs that continue under OICR, which have provided $25-million to improve the environment for cancer clinical trials in Ontario. These improvements include infrastructure funding to hire clinical trials professionals, a series of high-quality training workshops, a website to help patients find clinical trials and the Ontario Cancer Research Ethics Board (OCREB), a centralized model for research ethics review.

This year’s meeting began with updates from Kay Friel, Director of Clinical Trials Program at OICR, and Dr. Bob Phillips, Deputy Director of OICR. Friel focused on new developments and plans for the future, while Phillips reflected on the progress of the clinical trials program and explained how they fit into OICR’s broader strategy of making Ontario a world-leader in cancer research.

“Our goal at OICR is to do translational research that has an impact on cancer, an impact on patients and an impact on the economy. The benefits of research don’t happen unless discoveries are tested in patients,” Phillips said. “It’s been an amazing experience to work with the clinical research community. The success of our Clinical Trials programs has exceeded all expectations.”

Friel noted that since the launch of OCRN’s Clinical Trials Program five years ago, the percentage of Ontario patients who enrol in Clinical Trials has risen from five per cent to 13 per cent. “This is only possible because of your hard work,” she said.

In 2007, OICR announced a five-year Strategic Plan to guide the development of wide range of research initiatives, including a High Content Clinical Trials (HICT) Program. Led by Dr. Janet Dancey, a medical oncologist, the HICT program will focus on testing biomarkers and other new therapies in clinical trials.

At the meeting, Dancey explained that she and her colleagues will bring together investigators who need to test discoveries in clinical trials, maximizing the scientific content of clinical research in Ontario. OICR’s Clinical Trials Programs will work closely with the HICT Program to get its studies up and running in Ontario hospitals and cancer centres.

Broader context

To put clinical trials professionals’ day-to-day activities in a broader context, the group heard from Dr. David Dilts, a management expert who has completed in-depth analysis of the administrative complexities of cancer clinical trials. Dilts is Director of Clinical Research for the Knight Cancer Institute and a Professor of Health Care Management at the Oregon Health and Science University. He is also co-director of the Center for Management Research in Healthcare, an institute partly funded by the National Cancer Institute in the U.S. that applies management principles to reduce the time and number of steps required to open oncology clinical trials.

While it is very important for clinical trials to be properly documented to ensure research value and patient protection, Dilts’ research shows that clinical trials professionals are often burdened with paperwork that has no clear purpose. In one study involving cancer centres in the United States, he found that staff were spending a great deal of time filling out forms that managers assumed were required by regulators; but when he called the regulators, he discovered that many of the forms had never been a requirement.

Dilts used an anecdote from the Second World War to describe how people can create paperwork out of habit. When the British rapidly organized people to protect the homeland, the recruits had very little military experience and turned to manuals to learn how to march and arrange themselves on the parade square. When they stood at attention, the manual specified that men should stand several feet apart. Nobody knew why, but they obeyed the manual religiously, forming up in a strange pattern every time they came to attention. One day, someone who had served in the First World War came by, and was asked if he knew why the manual said there needed to be space between men on the parade square. “Oh, it’s so they can hold the horses!”

At the end of the story, Dilts said to Ontario’s clinical trials professionals: “I want you to consider: how many horses are you holding?”

After Dilts’ presentation, the meeting turned to OICR’s efforts to untangle and streamline processes for opening clinical trials in Ontario. Most of the discussion focused on the business plan for a central office to co-ordinate the start-up of clinical trials.

Currently, sponsors that want to open a clinical trial for enrolment at multiple sites in Ontario must deal separately with each site. OCREB can provide one-stop research ethics review for the majority of Ontario’s clinical trials sites, but other aspects of setting up and administering a clinical trial involve contacting administrators at each institution individually, multiplying the workload.

A central office will extend the centralized approach to the entire trial. In this model, an industry representative can contact the central office and specialized personnel will use streamlined processes to co-ordinate with clinical trials sites. Institutions will continue to maintain ultimate responsibility for running clinical trials, but opening a central office as an intermediary could drastically reduce the administrative burden of getting a study open in Ontario.

At the meeting, Phillips, Friel and Karen Arts, Director of Industry Partnerships at OICR, updated the group on the central office concept and invited their feedback. The central office has been tested in a pilot project, which has shown that the model can reduce paperwork and get studies opened for enrolment in shorter timeframes. OICR is now ready to work with centres to create a permanent central office based on the successful pilot project.

The group was enthusiastic about the central office and encouraged OICR to move forward with its plans. Over the coming months, Friel will continue working with clinical trials professionals and Arts will continue working with industry to refine the proposal for a province-wide central office model and get the initiative off the ground.

“The central office will reduce workload at cancer centres and help establish Ontario as the location of choice for researchers that need to conduct large-scale clinical trials, ultimately bringing the benefits of cutting-edge research to more patients in Ontario,” Friel said.