December 20, 2012 – The Standing Senate Committee on Social Affairs, Science and Technology released a report recommending that clinical drug trials need to be improved to ensure patient safety, especially among certain sub-populations, including seniors, pregnant women, and children. One of their major recommendations was that clinical trials should include members of the sub-populations for whom the drug are intended, to ensure the tested drugs are suitable for all intended patient. CARP has also advocated this, specifically recommending that older adults be included in clinical trials to ensure that drugs are safe for older adults, who are often most likely to be the main users the drug once on the market. Another major recommendation from the report was to standardize the approach to research ethics reviews for the approval of clinical drug trials so that Canada continues to have access to new research and drugs.
Ensure patient safety by including older adults in clinical trials
The study identified Canada’s need to change how clinical trials are designed, particularly with regards to the inclusion of vulnerable sub-populations in clinical trials. Traditionally, most clinical trials tend to use young adult males, excluding other sub-populations such as children, pregnant women, and older adults. These sub-populations have been excluded from clinical trials because they tend to have other complicating variables, such as developmental issues or multiple chronic conditions, which make it difficult to optimally measure the outcomes of a drug.
Sub-populations have been excluded also because they are more vulnerable to untested drugs – a justifiable ethical reason. For example, older adults typically have other health conditions in addition to the condition that a drug is being tested for. They may also be more frail than the general population, increasing their vulnerability to drug testing.
However, for many drugs that come on the market, the majority of the users are not young adult males but rather those belonging to the other sub-populations. There is little information about the potential effects of the drugs on those populations, which also increases their vulnerability and risk. Therefore, to ensure the health and safety of patients, the Senate Committee recommended that sub-populations be included in clinical trials, but with great regard for safety for those involved in the trials. This way, the clinical trials reflect the population that will most likely be using the drug, increasing patient safety.
Ensuring access to drugs
The study also identified the need to align requirements and guidelines with other countries to ensure Canada’s access to drugs. The stakeholder feedback that the committee received highlighted the lack of consistency across the trial sites and their research ethics review board guidelines. Without a standardized approach to research ethics reviews for the approval of clinical drug trials in Canada, companies bear costs to submit multiple research proposals, deterring them from doing more trials in Canada. Ensuring that Canada is a favourable destination for clinical trials is important for two main reasons. First, in the short term, it affects Canada’s ability to attract research dollars so that it can continue to do further research and clinical trials. And second, in the long-term, it will improve Canada’s access to new drugs to meet people’s health needs. As a result, the Senate committee calls on the federal government to better position Canada globally so that it becomes as preferred jurisdiction for clinical trials.
Drug safety should not be compromised
Additionally, the committee recommends that greater collaboration and networks between academic institutions, research networks and patient groups be formed since the networks will help promote the importance of clinical trials and improve patient recruitment, access to investigative drugs, and promotion of the inclusion of vulnerable sub-groups. CARP has also called for clinical trials to include older adults and for better access to drugs to meet the health needs of Canadians. It is important that drugs are tested for older adults, who will not only possibly have different responses to a drug but will also predominantly make up the majority of the population that will use the drug. As the report recommends, CARP calls on the federal government to take leadership to strengthen standardization and collaboration across the country to ensure that Canada does not fall behind in drug research and access and that the safety of Canadians is not compromised.