Why is Canada such a laggard on clinical trials regulation?

Readers respond to Science-ish blogger Julia Belluz

Adrian Wyld/CP

Science-ish has been trying to get to the bottom of why Canada lags, compared to global standards, when it comes to regulation and oversight of clinical trials. (See this open letter to the Federal Health Minister Leona Aglukkaq, subsequent letters from researchers, and last week’s interview with Health Canada.)

These posts struck a chord with the health community, and letters and tweets have continued to flow in. Here are the latest: Trudo Lemmens, an international expert in pharmaceutical regulation, writes about how Canada is failing in its “human rights obligations to protect the health and well-being of Canadians by allowing the continued hidden production of clinical trials data.” In contrast, Russell Williams, the president of Rx&D, writes about why Canada’s plan for a web-based listing of clinical trials is a “positive occurrence” and how “Canada’s innovative pharmaceutical companies support the Canadian economy and contribute to Canadians’ health and well-being.”

Standby for more in the coming weeks.

Dr. Trudo Lemmens, Scholl Chair in Health Law and Policy, and Visiting Professor, HeLEX Centre, University of Oxford

“The interview with Health Canada on the recent trial registration listing augments rather than diminishes concerns many of us have about this initiative. The ultimate goal of registration is greater transparency and accountability of drug development. Some early US registration initiatives focused decades ago on providing information about ongoing HIV/AIDS trials to patients, but there is now an international consensus that trial registration is needed as a tool to ensure reliability of data.

Promoting registration only as a tool to help patients make ‘informed treatments around investigational drugs’ is problematic in the absence of solid transparency measures. First, it creates a false impression that clinical drug trials are overall good treatment options. Most drugs tested in clinical trials never make it to the market, often because of serious side effects. Patients already tend to overestimate the benefits of new drugs and to underplay the risks.

Second, it downplays the real goal of clinical trials registration. Promoting access to trials without making sure through mandatory measures that independent experts and patients have access to reliable data resulting from these and earlier trials appears highly problematic. Reliable information about new drugs is already often lacking, and even more so if trials can continue to be used as marketing tools.

Trial registration and results reporting have been identified as crucial ethical requirements in the World Medical Association Declaration of Helsinki, which Health Canada recognizes as a leading international ethical standard for clinical trials. Back in 2008, the WHO Global Ministerial Forum called upon the countries to introduce registration and results reporting requirements. These have been made mandatory in several countries around the world and in the Americas, including in countries with fewer regulatory and financial means than Canada.

In the US, pharmaceutical companies who fail to register or report the results of clinical trails can be fined up to $10,000 per violation per day. Yet, Canada has only managed so far to introduce these as research ethics requirements for federally funded research, while it continues to politely ask for voluntary compliance by industry.

The Canadian regulatory response is simply inadequate and counterproductive. It is time to recognize that Canada is failing in its human rights obligations to protect the health and well-being of Canadians by allowing the continued hidden production of clinical trials data. The federal government has to prioritize the creation of firm regulatory tools so that Health Canada can penalize those who fail to comply with urgently needed transparency measures.”

Russell Williams, President, Canada’s Research-Based Pharmaceutical Companies (Rx&D)

“The creation of a web-based list of Health Canada authorized drug clinical trials is a positive occurrence. It is important to note that Rx&D members already report on clinical trials on www.clinicaltrials.gov and on the International Federation of Pharmaceutical Manufacturers and Associations’ Clinical Trials Portal.

Vibrant clinical trial activity contributes to a modern healthcare system and knowledge economy by helping introduce the latest health care innovations to patients and anchoring research activities across Canada. Recognizing the value clinical trials bring to their economies, our global competitors have adopted strategies to improve their offering to researcher and prospective investors with significant success.

Clinical trials activity in Canada declined in the last few years. Canada needs to regain its competitive edge and can do so by overcoming operational barriers and inefficiencies, and addressing the high costs of conducting clinical trials.

In September 2011, Canada’s first-ever National Clinical Trials Summit took place and gathered industry researchers and leading experts from academic healthcare organizations, academia and governments with the goal of making Canada a global leader in attracting clinical trial investments. In order to improve patient recruitment and to better measure, monitor, manage and market clinical trials, key recommendations coming out of the Summit include the development of a database of registries to identify eligible patients and a national recruitment strategy. For more information on the Clinical Trials Summit and to consult the Action Plan.

I’d also like to take this opportunity to bring your attention to some new resources on our website. To better understand the health and economic benefits of our innovative medicines, Rx&D commissioned reports from KPMG, RiskAnalytica, and SECOR. The three reports have been streamlined into one document: Saving Lives–Transforming Care outlines how Canada’s innovative pharmaceutical companies support the Canadian economy and contribute to Canadians’ health and well-being.”

Science-ish is a joint project of Maclean’s, the Medical Post and the McMaster Health Forum. Julia Belluz is the associate editor at the Medical Post. Got a tip? Seen something that’s Science-ish? Message her at julia.belluz@medicalpost.rogers.com or on Twitter @juliaoftoronto