Health Canada responds to questions about hidden clinical trial data

Timeline for web-based listing remains unclear

(Jeffrey Coolidge/Getty Images)

In Canada, pharmaceuticals are one of the fastest-growing cost drivers in our health system. And we are gobbling up prescription drugs with increasing enthusiasm. Between 1997 and 2007, Canadians were second only to Americans when it came to increases in per capita drug spending.

Yet the data we collect from clinical trials about the drugs we take remains largely hidden from view: it’s not available for examination by independent researchers, and the information about drugs that is published tends to be positive, an unrepresentative sliver of all that’s known. As the editor of the British Medical Journal and other doctors around the world have pointed out, this means patients, doctors and governments can’t make fully informed decisions about treatments.

This is a problem that affects anyone who uses pharmaceuticals — or their loved ones who do. Because of this situation, jurisdictions around the world have been working to make the clinical trials process, the testing of drugs, more open and transparent.

Yet Canada lags here. As Science-ish noted in an open letter to the Federal Health Minister Leona Aglukkaq, and subsequently, letters from researchers, the recent announcement about the government’s intention to create “a web-based list” of clinical trials for Canadian patients seems to reflect what was known about this issue over a decade ago, and ignores the evidence that’s been gathered since then.

After several phone calls and emails, the federal health minister’s office returned Science-ish’s call. A spokesperson for the minister said he was not in the position to comment on the plan, so he connected Science-ish to Dr. Pat Stewart, Health Canada’s senior executive director in Therapeutic Products Directorate. Here’s what he had to say about the “web-based listing”:

Can you tell me the details of what Health Canada is planning to do with the web-based listing?
We’re planning to seek stakeholder input into our plan to post an administrative list of clinical trials that we review and receive and have no objection letter to. This program was planned to address transparency and to allow Canadians that might be interested in finding out what trials Health Canada is authorizing, and would hopefully provide them with information they might find useful.

So sponsors of trials — researchers, pharmaceutical companies — they wouldn’t have to register their trials anywhere; Health Canada would automatically add them to this listing when they approve a trial in Canada?
This is not an action we are asking sponsors to do; this is something that Health Canada is going to do. The content and the posting of this information would be done by Health Canada. As part of our issuing of a no-objection letter to sponsors (meaning a trial can proceed), we ask them to voluntarily post or register their trial within 21 days of receipt of the letter on a publicly available clinical trials registry, like clinicaltrials.gov in the U.S. or the WHO clinical trial registry portal. The activity we are talking about doing now, this is something Health Canada would be doing.

What information will people see on the listing?
Say you were wondering what trials might be going on for prostate cancer, you can go to this list and see for that medical condition what trials Health Canada has authorized, what’s the drug, what’s the name of the company doing it. That would enable you to contact the sponsor, (to ask about) what trial is going on. . . It’s meant to provide information that would be useful for Canadians in making some informed choices about treatments around investigational drugs.

So, this doesn’t address the problem of the lack of oversight of trials?
Presently, in the regulatory framework, there’s no regulatory mandated requirement that clinical trial sponsors register their trial.

The issue that has been identified by the research community is that we need more stringent enforcement and oversight to make sure that trials and trial protocols are registered, so endpoints of trials aren’t changed mid-way through to make results look more favourable, and to make sure data doesn’t go missing so that the evidence base doctors work with isn’t skewed. As far as I can see, this listing Health Canada is proposing doesn’t address those issues.
It’s meant to address transparency and provide information to Canadians so they can make informed choices.

But does it address those issues?
It addresses providing information to Canadians about trials that are proposed to be started in Canada. The broader information is something that we continue to look at and we have sought out advice and input from a number of stakeholder groups. As we look at modernizing our (regulatory) framework, we are going to look at this issue as well.

Still, the well-identified problem with the clinical trials process is the perversion of the evidence base: we don’t have adequate follow-up and oversight of all the trials being done, there’s publication bias, negative results and trials go missing in action. These are all well-identified problems. But, again, this listing doesn’t seem to address any of those issues.
It was never meant to address the full spectrum of issues that have been brought forward. This was intended to be an initial step.

Why is Canada so far behind other jurisdictions in addressing these issues?
If you look at the international community, there are registries that post the commencement of trials and sites. The disclosure of results, I don’t think it’s something that any regulatory body has completely resolved. We have heard those comments and are looking at that. I’m not sure it’s a component of this issue that any regulator has completely worked through. We stay in tune to the discussion on this, and we are watching what our international partners are doing. Our decisions will be informed by that.

[Note: America’s trials registry, clinicaltrials.gov, created a database for results reporting in 2008. This requires that trial results are put on the database within a year of completion of the trial.]

The conversations around creating a clinical trials registry in Canada have been happening since 2005. It’s 2012, and still no registry.
There has been dialogue, yes, and Health Canada has gone out to seek input from external stakeholders.

Now we have this listing, but still no registry.
It’s not meant to be a fulsome clinical trials registry. . . Health Canada is open to the idea of more information being made available, more transparency, certainly we’re looking at opportunities for people to give input, on how best to do that. Health Canada is embarking on a multi-year project to modernize the regulatory framework for food and drugs in Canada. The registration of clinical trials has been identified as an initiative that will be looked at under that process. There’s an ongoing process on how best to do that.

The clinical trials listing seems like it could be a good opportunity for Health Canada to address some of the other issues regarding transparency and oversight of trials.
This is an interim step. . . We certainly support the initiative of peer-reviewed science journals that require trials be published on a clinical trial registry. These initiatives — it’s a multi-jurisdictional multi-stakeholder approach. . . We support scientific journals doing this sort of thing. It’s a step in the right direction, as well.

For those who want to have their say about this plan for the listing as part of a stakeholder dialogue, when will they be able to?
Timelines are not finalized. We’re hoping that moving forward on this notice to get the stakeholder consultation will be late fall, early winter. We’re hoping early December-ish. And a number of Canadians and stakeholders can provide their comments. If they watch the further notices about this, it will be publicly available, how they will be able to do that.

This interview has been edited and condensed.

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