WATCH: Doctors say Ottawa is creating a crisis by cutting funding for major drug trials – and eliminating important safeguards. Vassy Kapelos has our exclusive report.
OTTAWA — Doctors and scientists say Ottawa has quietly decided to cut funding for some major drug trials, eliminating a critical safeguard for Canadians’ health.
The cuts will hit large randomized controlled trials, or RCTs, which, for decades, have been considered the best way to determine whether drugs on the market are safe.
“Many crucial questions relating to the treatment of their medical conditions won’t be addressed,” said Dr. PJ Devereaux.
Devereaux is one of 140 doctors and scientists across the country who have written a letter, printed in full below, to the Canadian Institutes of Health Research (CIHR). The letter states the changes to the funding of major RCTs “…would decimate the field and have substantial negative consequences to scientific progress and the health of Canadians.”
Those changes, said Devereaux, include a de facto funding cap for trials.
According to Devereaux, major RCTs can cost between $3 million and $10 million — a cap, he says, will make those major RCTs “unviable.”
Though RCTs sound technical, the results of many are familiar to Canadians.
Menopause, for example, was long thought treatable with hormone-replacement therapy. A large RCT, however, where half the recipients were given a placebo, determined the therapy wasn’t working.
Devereaux said that’s an example of the kind of issues publicly-funded trials should be looking at — ones industry doesn’t have an interest in.
“Industry does a good job in terms of funding drug trials — but obviously they’re only going to fund things that relate to their products,” he said.
Dean Fergusson, a senior scientist with the Ottawa Hospital Research Institute, has worked on dozens of RCTs. He is currently looking at whether an RCT can be used to determine if age matters in a blood transfusion — another question, he said, industry doesn’t have a stake in answering.
“These trials have been practice-changing. They dictate what drugs and devices and interventions physicians use every day,” he said.
In a statement, a CIHR spokesperson wrote: “CIHR appreciates the valuable input of these researchers … CIHR agrees that funding for large RCTs has been competitive in recent years. However, the proportion of CIHR funding directed towards RCTs actually increased to 6.7 per cent of our overall budget in 2013-14.”
Read the full statement below.
The Minister of Health deferred questions to CIHR, but NDP health critic Libby Davies says she will push the issue when Parliament resumes in September.
“We’ve now seen so many letters from scientists and researchers — it’s part of a bigger picture … that we have a Conservative government that is just hell bent on cutting back on everything.”
Statement from CIHR:
CIHR appreciates the valuable input of these researchers, many of whom participated in the Strategy for Patient-Oriented Research (SPOR) Clinical Studies External Advisory Committee.
CIHR agrees that funding for large RCTs has been extremely competitive in recent years. However, the proportion of CIHR funding directed towards RCTs actually increased to 6.7% of our overall budget in 2013/14.
The issues raised in this letter (surrounding the funding of large RCTs) are topics of many discussions worldwide amongst funding agencies, pharma, and academic institutions. CIHR remains committed to supporting clinical research and strengthening the environment for clinical trials in Canada.
Improving the environment for clinical trials
Improving the clinical trials environment in Canada is one of the five elements of SPOR – a national coalition of federal, provincial, and territorial partners dedicated to the integration of research into care. A major initiative under this element is the Canadian Clinical Trials Coordinating Centre (CCTCC), whose mandate is to implement the nine recommendations summarized in the report To Your Health and Prosperity – An Action Plan to Help Attract More Clinical Trials to Canada. We believe that the establishment of the CCTCC and implementation of the action plan will enhance our trials environment and improve Canada’s ability to attract more clinical trials. Belinda Vandersluis has recently been named as the Director of Implementation and can be reached for further updates at firstname.lastname@example.org.
Funding large clinical trials
In a complementary activity, in December 2013, CIHR formed an internal group to discuss the challenges of funding large grants and clinical trials in the current funding climate. Participating in these discussions are Dr. Jane Aubin, several of our Scientific Directors with extensive clinical trials experience, and CIHR staff from both open and strategic programs.
No caps or limits on funding
With regard to the Project and Foundation schemes under our reforms to the open program, the letter states that these programs have maximum funding limits that will make it impossible for large RCTs to receive funding. It is important to note that these are merely the estimated ranges within which CIHR expects the majority of funding requests to fall, based on the historic distribution of funding. The relevant text can be found within the 2014 Foundation Scheme Pilot Funding Opportunity at this link:
Based on modeling of the historical data, it is expected that most Foundation grant budget requests will fall within a range of $50K to $1.5M per annum. Foundation grant levels will be commensurate with need, which is expected to vary by research field, research approach, and scope of program activities. While the funding opportunity for the project scheme is currently under development, the language will be consistent with what is noted above. That said, CIHR is currently exploring a mechanism to make funding decisions around large grants, including RCTs, that is consistent with the recommendation put forward by the 2011 international review panel: www.cihr-irsc.gc.ca/e/44567.html
Strategic funding, partner funding
CIHR’s Governing Council has also suggested that CIHR may need to consider an approach where large clinical trials will be entertained only in a strategic funding envelope, e.g., the trial is one of national priority, and also leverage a significant portion of the funds required from other partners. There are a number of discussions going on both nationally and internationally and many agencies are considering a similar approach.
Finally, the letter asks whether researchers will be able to compete for large RCT grants while holding a Foundation Scheme Grant. As the Foundation Scheme is designed to contribute to a sustainable foundation of new and established health research leaders, by providing long-term support for the pursuit of innovative and high-impact research programs, any individual who receives a Foundation Scheme grant as a program leader will not be able to apply for other open program grants (i.e., Project Scheme). They are eligible to apply to strategic funding opportunities.