While the Canadian regulatory authority, Health Canada, has made efforts to improve the transparency of its drug-approval procedures, clinical-trial information provided in Summary Basis of Decision (SBD) documents is still insufficient to give doctors a reliable basis for prescribing decisions, a new study claims.
According to Roojin Habibi, the lead researcher and a former York University student who collaborated on the study with Professor Joel Lexchin from the university’s Faculty of Health, key omissions from SBD documents included characteristics of the patients who took part in related clinical trials, as well as the results of those trials.
Health Canada introduced SBD documents in 2004, with the aim of bring more transparency to drug approvals by providing healthcare professionals and patients with better information about the clinical trials used to secure marketing clearance in Canada.
Habibi and Lexchin looked at 14 items of clinical-trial information in all SBDs published by Health Canada as of April 30, 2012.
They assigned each of these items scores for information present (two points), unclear information (one point) and information absent (zero points).
In addition, three overall ‘component’ scores were tallied for each SBD, depending on the extent to which the document answered three questions that clinicians might pose before prescribing a new drug:
- Do the characteristics of patients enrolled in the trials match those of patients in the clinician’s practice?
- What details are provided on the drug’s risks and benefits?
- What are the basic characteristics of the trials?
In total, 161 documents spanning 456 clinical trials were analysed. Results of the review were published online in the open-access journal PLOS ONE.
The majority of the SBDs – 121 out of 161 – were rated as having information sometimes present (score of >33% to 66%). There were no SBDs either without information on any item, or with 100% of the information.
Items in the patient-characteristics component scored worst in the analysis (mean component score of 40.4%), while the most frequently provided items were those corresponding to basic clinical-trial information (mean component score of 71%).
“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,” Lexchin noted.
He said Health Canada’s current transparency policy was outdated and ineffective compared with approaches taken by the US Food and Drug Administration and the European Medicines Agency.