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The following appeared in the Ottawa Citizen on March 9.
Worth the risks
Clinical trials are sometimes the best hope for patients
We appreciate the importance of articles such as the Citizen's recent series -- "Drugs, Money and Ethics" -- that strive to enlighten the public and expose weaknesses in the health-care system. However, we also recognize that a series such as this has the potential to tarnish an entire research community that is committed to bringing innovative and experimental therapy to those who need it the most.
At The Ottawa Hospital, clinical trials are considered an important part of innovative patient care for diseases where established treatments are not available or not adequate. Often the only alternative is an experimental protocol developed by our own scientific and medical staff or an experimental drug offered by a pharmaceutical company through a sponsored clinical trial.
Currently there are about 25,000 people enrolled in 925 clinical trials at The Ottawa Hospital. These range from a very early (phase 1) clinical trial to test the safety and feasibility of a virus to destroy tumour cells in patients with late-stage cancer to final testing of an approved drug in a late-stage (phase 4) clinical trial. Most of the studies are designed to assess the safety and efficacy of unapproved drugs, otherwise unavailable to our patients.
There is an ethical imperative to do research. Just one example of innovative research saving hundreds of lives is the series of clinical trials led by Ottawa Hospital physician-scientists, and carried out in centres throughout the world, to test multi-drug therapy on patients with HIV infection. These trials have been highly successful, and hundreds of AIDS patients worldwide are alive today as a result of this innovative approach.
While clinical trials are an absolute necessity for the creation of innovative therapies, the use of experimental procedures or unproven drugs is inherently risky, and for some the risks are considerable. A goal of any clinical trial, therefore, must be to manage and minimize the risk and explain this risk to the patient beforehand through the process of informed consent. Critical to this process is the institutional Research Ethics Board (REB) -- in the United States, called an Institutional Review Board. The purpose of an REB is to ensure protection of human research subjects. If this cannot be guaranteed, there is no justification for the research.
The Ottawa Hospital Research Ethics Board is mandated to review all proposed research involving human subjects, and planned research cannot go ahead without its approval. The REB has about 12 members, including scientists, nurses, doctors, other health-care professionals and members of the public. They assess about 20 research protocols a month, an onerous task requiring hours of reading and long meetings. Each review is far-reaching and begins with consideration of whether the study is a good idea. Does it address an important problem? Will the study, as designed, answer the question it poses? Are there enough patients enrolled in the study for it to be meaningful, yet not so many that it exposes an unnecessary number of patients to risk?
The questions continue. Are patients' rights respected? Is participation voluntary, and consent obtained without coercion? Will confidentiality of information be maintained? What are the risks, what are the benefits, and are the risks reasonable in the light of the expected benefits? These considerations get special attention in the context of severe illness or urgent therapies.
The REB must also decide whether the researcher is sufficiently expert to run the study and whether the research staff is trained to execute the study. It also considers what benefit the investigator derives, if any, and must agree that it is reasonable in view of his or her time and effort. As our colleague, Dr. Richard van der Jagt, pointed out his recent letter to the editor ("Doctors do not profit from drug-research patient fee," March 1), many studies pay a fee per patient enrolled in the study, but little of this (usually none) goes to the physician conducting the trial. The fee covers the salary of the clinical research co-ordinators who work on the study and pays for services (such as X-rays, CT scans and laboratory tests) that are required for the trial, but would not otherwise be required by the patient.
In rare cases where a complex study requires a major time commitment from the physician, the REB allows compensation at the same rate that he or she would receive from the province to treat patients with non-experimental therapy.
We know that our system is not perfect, and therefore we strive to improve our educational efforts, our review procedures and our ability to deliver innovative therapy with minimum risk and with scientific integrity. Transparency and accountability are two essential components of our approach. We are working, for example, to eliminate any financial advantage for researchers to perform drug company-initiated studies. If there are funds that remain unspent at the end of a study, we insist that they be re-invested in research and education. These funds are held in accounts with terms of reference and control measures that are external to the investigators.
Three years ago, the Ottawa Health Research Institute was created as the research arm of The Ottawa Hospital, affiliated with the University of Ottawa. It has more than 100 scientists, 150 clinical investigators who participate in clinical trials and 230 graduate students and research fellows -- more than 1,000 people involved in the research enterprise. With an annual research budget of $63 million, we take our research very seriously, and strive for excellence in all aspects of research.
Our research staff are professionals in every sense of the word, and we take great pride in our achievements. With an enterprise of this size, conducting 8,000 hours worth of research every day, mistakes do occur; human errors sometimes creep in, and "fail-safe" systems sometimes let us down. We work to improve these systems and to address any errors.
To us, trust -- the trust of our patients, of granting agencies, of sponsors, and of the Canadian public -- is a vital commodity that we must earn every day. It is through the excellence of our work and the maintenance of high standards in all aspects that we will maintain and enhance the excellent reputation of our Institute. We should not forget this when we think back to the regrettable incidences highlighted by the Citizen series. We should rejoice in our successes and learn from our mistakes, bearing in mind the purpose of the clinical research enterprise: the well-being of our patients, past, present and future.
Ronald Worton is vice president researchat The Ottawa Hospital, CEO and scientific director at the Ottawa Health Research Institute, and a professor in the Department of Medicine at the University of Ottawa.
Raphael Saginur is a physician in the Division of Infectious Diseases at The Ottawa Hospital, an associate professor in the Department of Medicine at the University of Ottawa, and chair of The Ottawa Hospital Research Ethics Board.