OICR updates industry on plans for making Ontario a world leader in clinical trials
OICR’s clinical trials experts sat down with industry representatives in mid-January to explain and seek feedback on the Institute’s plans for making Ontario a leading jurisdiction for clinical trials.
The fifth annual OICR Industry Advisory Board (IAB) meeting took place on January 15 in Toronto. The IAB consists of representatives from Ontario’s pharmaceutical and biotechnology sectors, including the world’s largest pharmaceutical companies and smaller Ontario-based firms.
The meeting began with an introduction by Dr. Bob Phillips, OICR’s Deputy Director. Phillips gave an overview of OICR’s development, placing clinical research within the context of OICR’s broader mandate to establish Ontario as a centre of excellence in a range of cancer research activities.
When OICR was founded in 2005, it absorbed the Ontario Cancer Research Network (OCRN). OCRN was founded in 2001 with a mandate to enhance Ontario’s clinical research environment by supporting clinical trials infrastructure and boosting patient recruitment. Many oncology clinical trials are sponsored by industry, and almost all new cancer therapeutic agents are developed by industry. OICR is continuing OCRN’s mission to attract more industry-sponsored clinical trials to Ontario. The IAB was originally established to provide OCRN with an industry perspective and continues to advise OICR through the annual meeting and one-on-one consultations with Karen Arts, OICR’s Director of Business Development.
Phillips explained that OCRN and OICR have been quite successful at making Ontario a better place to conduct clinical trials. Hospitals and cancer centres received infrastructure funding; clinical research professionals have access to a high-quality educational workshop program developed by OICR; investigators have access to centralized research ethics review; and patients can now browse cancer clinical trials for which they might be eligible on a user-friendly website, OntarioCancerTrials.ca. Between 2004 and 2007, the percentage of cancer patients enrolling in clinical trials increased from below five per cent to 12 per cent.
Building on successes in infrastructure and enrolment, Phillips said OICR is now poised to tackle a more fundamental problem in the world of clinical research. “Currently, 70 to 80 per cent of Phase III oncology clinical trials fail,” he said. “Clearly, we're making a lot of bad decisions in the early stages. We want to improve the research process to do a better job of matching good science with clinical research.”
To this end, OICR has established a High Impact Clinical Trials Program. Dr. Janet Dancey, a medical oncologist with extensive experience in the co-development of experimental drug therapies and biomarkers, was recruited to lead the program last year. It will focus on launching clinical trials that obtain maximum research value by bringing together researchers involved in testing new clinical products with novel imaging and bio-specimen based tests, often from across different disciplines. The trials will seek to maximize information obtained by not only determining the risks and benefits of a new therapy, but also by determining markers to identify which patients might be at risk for adverse effects or more likely to benefit from the treatment.
In a presentation to the IAB, Dancey noted that industry is an important stakeholder for her program. In addition to sponsoring the majority of cancer clinical trials of new drugs, industry collaboration with academic researchers is essential for effectively moving scientific discoveries into new treatments for cancer. Dancey explained that advances in biomedical research have led to a mismatch in capacity between the laboratory, where discoveries are made, and the clinic, where results are validated.
“Business as usual is no longer tenable, because there are too many discoveries to test,” she said. “The focus of our High Impact Clinical Trials program will therefore be early translation – on the critical stage of the research project where a discovery must be taken from the lab and transformed into a modality that can be successfully tested in humans.”
The program will be highly collaborative, bringing researchers together across disciplines to tackle the toughest challenges in clinical research and working with other funders and industry to launch studies. The HICT program will work closely with existing OICR research programs, which are likely to lead to new targets, biomarkers and imaging modalities that will need to be tested. It will benefit from OICR’s Clinical Trials Programs, which have made it easier to open studies in Ontario and recruit patients.
The IAB also heard updates from OICR’s Clinical Trials Programs and the Ontario Cancer Research Ethics Board (OCREB). The discussion focused on OICR’s efforts to establish a central office for clinical trials, which will offer clinical trials sponsors a one-stop approach to getting a trial up and running in Ontario.
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 other aspects of opening and running clinical trials. In this model, an industry representative can contact one person at the central office to express interest in opening a trial for enrolment in Ontario. Specialized personnel at the central office will then use streamlined processes to co-ordinate with clinical trials sites, working behind the scenes on paperwork and other administrative issues. Institutions will continue to maintain ultimate responsibility for running clinical trials.
Adding a central office as an intermediary between the institutions that run clinical trials and the companies that sponsor them could drastically reduce the administrative burden of getting a study open in Ontario. This could in turn help establish Ontario as the location of choice for pharmaceutical companies that need to conduct large-scale clinical trials.
Janet Manzo, Executive Director of OCREB, noted that a central office could also improve the research ethics review process. It is up to the principal investigator (PI) rather than the study sponsor to apply for research ethics review before enrolling patients in a study (the PI is an academic researcher who collaborates with the company sponsoring the trial). In addition to helping sponsors find PIs, the central office could also help PIs with the considerable amount of paperwork involved in preparing a submission to a research ethics board.
Representatives of Amgen and Pfizer each presented briefly on their experience with a pilot project for the central office. Steve Dmytrasz of Amgen told the IAB that OICR was able to help his company find the best sites in Ontario to open a clinical trial for head and neck cancer. Sophia Camels of Pfizer compared two recent studies; one was co-ordinated through the OICR pilot project and the other through her company’s usual process. The study that went through the OICR pilot experienced fewer delays and opened sooner.
Members of the IAB were receptive to the plans outlined at the meeting. They encouraged the Institute to continue developing the central office and move forward with other projects to reduce delays. Taken together, the process changes that OICR is implementing could have a major impact on clinical research – and on drug development.
“It actually takes twice as long in 1990s to get a drug developed as it did in the 1960s,” Kay Friel, OICR’s Director of Clinical Trials Programs, told the group. “In today's regulatory environment it is more difficult to get clinical trials up and running at multiple institutions. If we can streamline the start up process and make it more efficient, we could ultimately get new treatments to patients sooner."
