Researchers call for EMA-style transparency regulations in Pan-America
The report, part of a series of articles published by BMJ, provided a comparative analysis of clinical trial transparency provisions in regulations, policies, and guidelines in three Pan-American Health Organization (PAHO) jurisdictions: Brazil, Argentina, and Canada.
The report argues that PAHO jurisdictions should follow the lead of the European Medicines Agency (EMA), “which now has a policy that such data is not commercial confidential information, and imposes on pharmaceutical companies duty to justify why specific subsets of the data file have to be kept confidential,” Trudo Lemmens, one of the paper’s authors and professor of health law and policy at University of Toronto told us.
“Data is fundamentally a ‘public good’, which runs counter to the notion of commercial confidential information,” said Lemmens. Commercial confidential information refers to the set of guidelines in which a government can determine data to be confidential and unable to be viewed without a specific disclosure agreement.
Lemmens believes that clinical trial registration is often seen as the definitive answer to trial transparency issues. However, without access to research results and full data sets, registration is of limited value.
Lemmens called Canada is "an interesting example" as the country doesn’t explicitly impose clinical trial registration. However, the country is now moving further with a new data access policy, he said, citing a recent court decision in Doshi v. AG Canada, which “may turn it unwittingly in a leader in clinical trials transparency.”
The major court case Lemmens mentioned is Doshi V. AG Canada in which Dr. Doshi sought judicial review of his refusal to sign a confidentially agreement while trying to obtain access to clinical trial data. The ruling stated that Health Canada “could not decide whether or not data can be disclosed.”
Brazil an emerging market, compared to Canada as an established market, has transparency and research ethics regulations that seem to be sophisticated on paper, Lemmens said. Yet, budget restrictions combined with a lack of government resources hinders trial transparency in practice.
According to the report, regulations on both a national and international level aren’t coordinated and may contradict each other.
Lemmens stated, “You have research funding agencies and organizations involved in the promotion of research emphasizing data transparency, but then other agencies and organizations recognizing that data may constitute commercial confidential information and approaching data sharing as an exception rather than a rule.”
The problem is that while research governance system “clearly recognize the public role of research ethics committees, several countries fail to regulate them adequately,” Lemmens said.
“In order for them to really fulfill their public role, they should be fully independent and not submitted to the financial interests at stake in drug development,” he added.
Additionally, data access allows researchers to identify issues that are not yet known, which “becomes more and more important in the era of big data,” Lemmens said. He also stated that developments in trial transparency can reduce waste in clinical trials, and thus reduce costs of drug developments.
“Unfortunately, in many countries, trial registration has been embraced as if it solves the problem of hidden data,” Lemmens said. “It doesn’t, and countries should move further and implement data sharing along the lines of the EMA policy and not just organize trial registration.”