TORONTO, March 20, 2014 — Despite increased transparency in Health Canada’s drug approval policy, doctors are still not getting key clinical trial information that will help when prescribing new drugs to their patients, a new York University study has revealed.
“Characteristics of the patients participating in clinical trials, and the results of those trials, were among the key omissions in information that we found in Summary Basis of Decision (SBD) documents,” says Roojin Habibi, the lead researcher and former York student working with Professor Joel Lexchin in the Department of Health Policy and Management, Faculty of Health.
Health Canada introduced the SBD documents in 2004, with an aim to improve transparency of the drug approval process by providing healthcare professionals and patients more information regarding the clinical trials used by Health Canada to accept a new drug for marketing in Canada.
With the SBD initiative, industry experts and stakeholders hoped that more informed prescribing decisions could be made. But according to the researchers of the current study, there is still not enough detail provided about the patients in the trials for clinicians to know if those patients resemble the ones they see in their offices. In an article titled Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada, published in the peer-reviewed journal PLOS ONE, they also observe that trial results are not shared to convey an understanding of the risks and benefits of the drug.
“There was also inconsistency in information provided from one SBD document to another, with no obvious logic to the order in which information was presented and the type and/or level of detail of the information discussed,” says Lexchin.
Lexchin, who is also a practicing physician, notes that Health Canada’s current approach to transparency is outdated and ineffective compared to that of the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) of the European Union.
The researchers took into account 14 items of clinical trial information from all SBDs published as of April 30, 2012, and gave scores for information present (2 points); unclear information (1 point); and information absent (0 points). The items were grouped into three components — patient characteristics, benefit/risk information, and basic trial characteristics.
“We reviewed 161 documents, spanning 456 trials, and the majority were rated as having some information present. However, while items corresponding to basic trial information were often provided (71 per cent), items in the patient characteristics component scored the poorest with 40.4 per cent. This clearly indicates that clinicians are being denied crucial tools for decision-making,” Habibi says.
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