The TMF is the official record of the clinical study for Regulatory Authorities, be it…
I read, with great interest, the article published this Tuesday (09/16/14) in the Toronto Star on Drug-testing rules broken by Canadian researchers, which was also picked up by The Wall Street Journal’s Pharmalot Blog.
Make no mistake about it – drug testing is a serious business. Compounds under development, that are yet to be marketed must undergo years of rigorous testing before being approved. I believe that the public should know that there are extremely strict industry guidelines dictating this process as well as serious sanctions for health care professionals who are willfully negligent.
The conduct of trials is very closely scrutinized by regulatory agencies such as Health Canada and the US Food and Drug Administration (FDA) as well as drug companies themselves. Canadian clinical research is in fact not the wild west, as people might be led to believe by this article. Nor is it inferior to that of the U.S. On the contrary, the high quality of Canadian clinical research is recognized internationally, notably by the FDA. I’m in no way implying that the mistakes highlighted in this article should not be taken very seriously, nor that mistakes are never made, but they need to be viewed in the proper context and people should be made aware of what percentage this represents out of the entire clinical research spectrum across the country.
Consider this argument from Dr. Janet Dancy, the Program Director for High Impact Clinical Trials at the Ontario Institute for Cancer Research (OICR)
“There are literally millions of data points, hundreds of thousands of patients, hundreds of clinical trial investigators and staff and procedures and processes in a clinical trial. Errors are made but because of internal and external quality control and quality assurance measures, they are detected and fixed. A trial database is never perfect, but a great deal of effort goes into making sure that it is as true as humanly possible, given both human and other resource constraints.”
To support the claim that the quality of Canadian clinical trials are among the best in the world, we looked at the FDA’s website and filtered through all the “Data Audit” inspection notifications available. These are sorted by country and then by finding. The following results confirm the low incidence objectionable conditions found by FDA inspectors at Canadian research sites:
On another note, it’s also very important for the public to know that drug testing as it is referred to in the Star’s article, but more accurately defined as clinical research, is instrumental in shaping new and better treatments and that these trials often result in closer patient follow ups. For these reasons, among others, we all have a vested interest in promoting clinical research in Canada. If we choose to be influenced by fear mongering, and allow ourselves to become an anti-clinical research society, we are accepting that the quality of our healthcare will stagnate at a time when we are in desperate need of advancement.
Our aging population is at greater risk of developing diseases such as cancer or Alzheimer’s. Advances in these areas are badly needed. Unfortunately, the article failed to look at the positive aspects of clinical research in this country and casts an unwarranted and damaging shadow over clinical research in Canada, which can only have a negative impact on the future of health care in this country.
What the public needs is more unbiased reporting, and greater awareness of trustworthy online sources for information such as that provided by The Center for Information & Study on Clinical Research Participation & N2 (Canada’s Alliance for Excellence in Clinical Research) so we can formulate more educated opinions on this subject. For added security, drug developers would also benefit from forming business partnerships with local clinical research experts.
If you have an opinion on this article or on the state of clinical research in Canada in general please share your comments below. By ensuring the lines of communication remain open, we can ensure more ethical and transparent behaviour on behalf of all stakeholders.
Denise Deakin (firstname.lastname@example.org)
Ms. Denise Deakin began her career as a registered nurse and gained pertinent experience through her work on clinical trials in the hospital setting, a career in pharma and finally in her active role as President & Co-Founder of Scimega Research Inc . Ms Deakin is instrumental in developing strategies to attract oncology clinical trials to Canada. Ms. Deakin is a representative of collaborative industry groups at both the provincial and national level whose mission is to raise the profile of both Quebec and Canada on the global clinical development landscape. She is also a frequent speaker at industry conferences, seminars and symposiums. She has 25 years of industry experience.
Dr. Janet Dancey is the leader of the High Impact Clinical Trials program at OICR and the Director of Clinical Translational Research at the NCIC Clinical Trials Group. The High Impact Clinical Trials program will facilitate the translation of discoveries from laboratory to clinic by providing infrastructure and resources to support trials evaluating markers for early diagnosis, prognosis, and predication of benefit to help develop better treatments for cancer patients.