Clinical trials hindered by red tape: MDs
Red tape is hampering clinical trials in Canada and other countries, the Canadian Medical Association Journal says.
Clinical trials are used to test new drugs and surgical treatments against old ones, and to see whether an existing drug or treatment can have other uses.
"There is no question that research participants need protection," Dr. Paul Hébert, editor in chief, and his co-authors wrote in an editorial in Monday's issue of the CMAJ.
"But regulations have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard. Consequently, clinical research has been substantially decreased among industrialized countries."
For example, the Canadian Cancer Research Alliance reported a decrease of 20 per cent in 2008 in the number of patients with cancer recruited into clinical trials.
"We're at risk of losing something that Canada's been very good at," said Joseph Pater, vice-president of clinical and translational research at Cancer Care Ontario.
Since Europe brought in new regulations in 2004, the largest cancer research network saw a drop to seven new trials in 2005, from 38 in 2001, with an estimated 85 per cent increase in the cost of running individual trials, the Journal's editorial noted.
Research trials increasingly cross national borders, it said, so simpler rules are needed to:
- Ensure patient safety.
- Collect information accurately and reliably.
- Provide fair and balanced information to research participants before they consent.
One of the current monitoring approaches, known as Good Clinical Practice Guidelines, runs to several hundred pages of quality assurance checks and balances that are based on limited evidence, the editorial argues.
"Instead of developing and adopting proper, study-specific standards, we have institutionalized ineffective monitoring for all clinical research, including lower-risk academic studies. International bodies, regulatory authorities, the academic community and major granting agencies can work together to fix the system," the authors wrote.
Opportunity for patients
The increasingly bureaucratic rules get in the way of making medical progress that improves the health of patients, agreed Dr. Salim Yusuf, a professor of medicine at McMaster University in Hamilton who conducts clinical trials in cardiology.
The United Kingdom has a single ethics board that reviews trials on behalf of all hospitals, instead of each hospital and company having their own review board as in Canada.
Pharmaceutical companies, federal and provincial governments and the Canadian Institutes for Health Research (CIHR) are working together to see if a similar streamlining process would work in Canada while protecting patients.
Each hospital participating in a trial in Canada also negotiates its own contract with pharmaceutical companies, but a common approach might speed up the process, said McMahon, who also chairs the Rx&D medical/clinical subcommittee at AstraZeneca Canada.
The CIHR is also looking at how clinical guidelines are actually applied to different types of patients, such as those living in rural areas.
"Ten or 15 years back, you have [a] one- or two-page consent," said Yusuf. "Now it's a 14-, 15-page consent. And imagine a patient coming in with a heart attack and you're trying to test a potentially useful new drug. To give them a 14-page consent is just, it's meaningless."
The danger of the bureaucratic guidelines is few good quality studies will be done, patients' health will suffer and fewer investigators will go into this important field of science, he added.
"Doing trials in a country like Canada does offer patients the opportunity to participate and get access to medicines that are not available for them through the health system, so reduction in trials unfortunately does have that consequence," said Dr. Catriona McMahon, vice-president of medical affairs at AstraZeneca Canada Inc. in Mississauga.
Since Canada has fewer patients per location compared to China, Brazil and India, both McMahon and Yusuf pointed to cost and efficiency issues here.
There is a move in Europe to simplify the process for academic studies, Yusuf said. It would help if Canada and the U.S. did the same, he said.
Currently, ethical reviews are done at an institutional level, but they do not have the authority and expertise to protect patients enrolled at other sites, the editorial writers said.