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Standardize clinical trials to gain global attraction, says Senate committee

By Laura Ryckewaert      

But some experts say standardization won’t address the main problem.

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The Senate Committee on Social Affairs, Science and Technology is calling on the federal government to standardize ethics reviews and establish a national framework for clinical trials in Canada in order boost its international appeal, but while the committee’s recommendations to increase clinical trial activity in Canada have been well-received by some academics, Urszula Kosecka, coordinator of Humber College’s clinical research program, says coordination and standardization won’t address the industry’s “bottom-line” concern over costs.

“The reason why we are losing clinical trials is very simple, it’s the budget. …[A national framework for coordinating clinical trials] is kind of an independent topic from why the studies are leaving Canada. It doesn’t matter if we have standardized or not standardized, centralized versus local ethics review, it still will not influence where the studies will be conducted, I’m pretty convinced about that,” said Dr. Kosecka in an interview with The Hill Times

“The ethics board review or other kinds of administrative issues, they do not have that much influence on the bottom line, as I said the bottom line is dollars…even though the process of setting up in other countries [like India] will require a little bit more time and money just because maybe the training is not there in place. So it needs to be implemented before the study will start, but then the cost of executing every task is much, much more cost efficient.”

Dr. Kosecka said salaries are simply higher in Canada than in countries like India or China, which are both increasingly popular locations for clinical trials, and she said salaries make up a significant portion of trial costs. 

Dr. Kosecka said while she does “agree” that standardization is an issue, she said “this is kind of a different topic and this has no influence on clinical trials in Canada regarding the number of clinical trials.” 

Last November, the Senate Committee on Social Affairs, Science and Technology tabled its report titled, “Canada’s Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines,” the first of a planned series of four reports looking at prescription pharmaceuticals in Canada, overall.

The report was adopted by the Senate on Dec. 4, along with the request for a response from the Health minister, and listed a total of 12 recommendations to improve clinical trials, including recommending the government establish a national framework and coordinating office for clinical trials, make the registration and publication of trials a requirement in Canada, and establish a national standard and accreditation system for research ethic review boards. All of these recommendations were seen as measures to reduce time and costs associated with clinical trials in Canada.

The committee found that over the last decade, the proportion of “global clinical trials” being conducted in Canada has declined. In 2007, a total of 776 clinical trial applications were submitted to Health Canada’s Therapeutic Products Directorate—which regulates pharmaceutical drugs for human use in Canada—but in 2011, only 537 clinical trial applications were submitted—an approximately 30 per cent reduction.

“While the quality of clinical trials has always been high in Canada, the drug industry suggested that this is no longer sufficient to give Canada a competitive advantage. Other developed countries have caught up to Canada. …The aspects of cost and speed were described as aspects where Canada falls short and are reasons for the declining clinical trials activity in this country. The high cost and slow implementation of clinical trials was attributed to the lack of clinical trial infrastructure in Canada,” reads the Senate report. “Canada can no longer rely on an international reputation for conducting good-quality research to attract clinical trials to this country.”

The committee found that countries like India, China, and Russia were increasingly popular hosts for clinical trials because they have both a vast population base from which participants can be pulled—one of Canada’s selling points—and “reduced operating costs associated with running clinical trials.”

Aside from quality, the committee found that companies looking to hold clinical trials are most concerned with cost, and time is an “important element of cost,” reads the report. 

The “absence” of standardization in research ethics reviews in Canada “significantly impacts the time required to start up clinical trials,” and the report called on the government to improve “clinical trial infrastructure so that efficiencies can be realized.”

“Witnesses spoke of the duplication of efforts when submitting protocols for ethics review at multiple sites, and the frustration of receiving different responses for seemingly identical submissions,” said the report. 

“Considerably more time and effort is needed to get clinical trials designed, approved and started in this country. As a result, the cost of testing drugs in clinical trials is high in Canada, making it less desirable to the industry as a destination for clinical trials.…The committee is calling on the federal government to take initiatives that will position Canada more favourably on the global stage as a preferred jurisdiction for clinical trials.”

The Senate Social Affairs and Science Committee is made up of chair Nova Scotia Conservative Senator Kelvin Ogilvie, deputy chair Ontario Liberal Senator Art Eggleton, P.E.I. Liberal Senator Catherine Callbeck, Nova Scotia Liberal Senator Jane Cordy, Quebec Conservative Senator Jacques Demers, Saskatchewan Liberal Senator Lillian Eva Dyck, P.E.I. Liberal Senator Elizabeth Hubley, B.C. Conservative Senator Yonah Martin, Quebec Conservative Senator Judith Seidman, Ontario Conservative Senator Asha Seth, Quebec Conservative Senator Josée Verner, and Quebec Conservative Senator John Wallace. 

“Clinical trials are really important for Canadians. If clinical trials are not done in Canada, a new drug may not be offered for sale in Canada [because Health Canada wouldn’t have information from Canadian studies or clinicians]. Secondly, clinical trials use highly-skilled research teams and it’s an expensive process so clinical trials support the development of highly-trained research teams in Canada, and then these teams are available to advise Canadians once a new drug is approved for sale in Canada. And finally the clinical trial process is, as I said, very expensive and it’s therefore a very important economic benefit to Canada to have clinical trials occur here,” Sen. Ogilvie told The Hill Times.

According to the report, in 2010 the pharmaceutical industry invested $110-billion in “research and development, globally,” and out of this, Canada attracted only $1.3-billion in investments—an estimated $1-billion of which was invested in clinical trials.

But while the Senate report found that a national framework for conducting trials and a national standard for ethics reviews would streamline the process so as to reduce both time and costs, Dr. Kosecka said while there “a lot of pros” to standardizing and centralizing research ethics boards, she said there are downsides.

“The patient should be protected and many aspects are not physical aspects. This is social integrity, it’s cultural integrity, it’s psychological integrity, and we need to take into consideration how are we going to protect the patient. The decision-making process is different in different communities, so that again needs to be taken into consideration when enrolling patients from different communities. The centralized board cannot supply that,” said Dr. Kosecka. “There’s worry that centralized boards will be completely silent about all those aspects which I mentioned, it will be more like almost a manufacturing process, making sure that maybe some of the elements…are in, but not really referring to sensitivity of the specific community.”

But Glenn Brimacombe, president and CEO of the Association of Canadians Healthcare Organizations, said the Senate report “largely confirms” an action plan developed by the association last spring to improve clinical trials in Canada. 

The plan included designing a “national coordinating office,” and Mr. Brimacombe said the government, the academic community, research institutes, and the pharmaceutical industry need to work in partnership to address problems facing clinical trials in Canada.

“We need to look at all three of those dimensions [cost, speed and quality] and put together an action plan that makes sense,” said Mr. Brimacombe, who said Canada is doing a good job when it comes to clinical trials, “but we need to do a better job.”

Sen. Eggleton told The Hill Times that Canada has a “piecemeal process” for ethics reviews, which adds costs and time and “detracts for our competitiveness.” 

“So if you’re going to have different ethics review entities in the country, you at least have them on a common basis for examining the drug,” said Sen. Eggleton.

Sen. Ogilvie said the committee wants to see one established or one, national “best possible” standard for research ethics board approvals, but he said the committee isn’t recommending any sort of “weakening” of requirements and stressed the importance of ensuring the safety of Canadians.

“Let’s suppose that there’s an applications for a clinical trial in Canada, and let’s suppose that there are 300 different clinical research teams and centres that want to be involved in that clinical trial. Right now, each of those 300 is likely to have a different ethics board review processes. The criteria varies. So if you were applying to do a clinical trial you would have to submit a completely new document to each separate clinical trial site, and you can imagine that a clinical trial document is a very substantial document that a pharmaceutical company would have to submit for approval by a research ethics board. And even if you have to change it in just a small number of ways in a few sections of a report, that’s a lot of different effort, and if you have to do that several hundred times, that’s a lot of expense,” said Sen. Ogilvie.

Cailin Rodgers, press secretary to Health Minister Leona Aglukkaq (Nunavut), said the minister has received the report, “and at this point we’re still reviewing it.”

“We thank the Senate for their work… and we’ll have some comments once it’s reviewed,” said Ms. Rodgers.

Transparency of clinical trials was another problem area highlighted by the Senate committee’s report. The committee noted that since 2004 there have existed international requirements to register clinical trials and make them publicly accessible, and in 2005 the World Health Organization developed standards for trial registration. But the committee found that Canada’s Food and Drugs Act has no registration requirements for clinical trials and that while Health Canada encourages transparency, the department has “no authority to compel” it. 

The report recommended the government “immediately require clinical trial registration,” and make information on the nature and findings of clinical trials in Canada publicly accessible.

On Oct. 18, Ms. Aglukkaq announced the government’s “intention to create a web-based list of Health Canada-authorized drug clinical trials,” according to a news release which also stated that, “Health Canada is committed to providing updates on progress related to clinical trial registration and disclosure, and feedback will be taken into consideration as the project moves forward.”

As well, the report noted that when it comes to rugs for rare diseases, also called orphan drugs, Canada is “the only developed country without an orphan drug policy and that is having an impact on clinical trial activity in this country.”

“It is also having an effect on the proportion of orphan drugs that seek approval in Canada, compared to other jurisdictions such as the U.S. and EU,” reads the Senate report. “Members were told that an orphan drug policy could provide incentives to companies to develop and test orphan drugs in this country.”

lryckewaert@hilltimes.com

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