Outsourcing clinical trials: Further thoughts
A story on the outsourcing of clinical trials appeared recently in the National Post. We’ve written about this topic recently here and the National Post article reiterates a few of the key concerns about outsourcing. This article also addresses the issue of outsourcing from the perspective of some Canadian researchers who have taken their projects elsewhere.
Here’s the story: Outsourced side effects
Here are a couple of things that I found most interesting about this article:
The comments from researchers interviewed for the story seem to demonstrate, to some degree, limited understanding of the usefulness of research ethics review. One researcher from the University of Toronto claims that the kinds of processes required in order to be allowed to conduct research are “bogging down” researchers so they are turning to other locales to conduct research. Canadian review processes are supposedly part of the problem. Outsourcing clinical research doesn’t necessarily solve that problem, however. Research being conducted in other countries still requires ethics review in Canada at the institution at which the researcher is affiliated or in the case of a pharmaceutical company, with an independent or private Canadian ethics review board to ensure that the research processes adhere to our federal guidelines. The kind of processes that “bog” researchers down can actually help to avoid the problems that are reported by researchers elsewhere in the article. A Canadian ethics review process can’t always anticipate the kinds of local problems identified in the article (like falsification of data or research being conducted on persons without consent), but it’s a good start to avoiding them. While the bureaucracy to which this researcher refers is a source of much frustration for researchers, these processes can help to facilitate the rigourous and ethical conduct of research — wherever it’s being conducted.
The model requiring “local ethics review”, mandated by the Tri Council Policy Statement also means that some kind of review needs to happen wherever the research is outsourced to. This is a necessary part of gaining access to other locales and helps researchers to begin to understand local issues, standards and concerns.
Some researchers may claim that the process of an ethics review in a country where research is outsourced to would lack the same kind of rigour or validity of the processes we have here. The article quotes one researcher, commenting on a kind of cultural divide he experienced when problems occurred with the data from his research project, outsourced to Iran:
“It’s a different culture, a culture with a lack, perhaps, of a long-standing research tradition dedicated to high standards and integrity.”
It’s dangerous to make broad negative generalizations about the “lack” of research integrity in other countries while claiming a kind of moral high ground here in the developed world. We’ve certainly had our share of research scandals. We’ve seen (and blogged about) researchers falsifying research to make themselves look better, to make a product or medicine appear more favorable than it really is or to promote a product or person. We’ve read about researchers ignoring conflicts of interest, forging signatures of colleagues and claiming research as their own that in fact is not. The list goes on. What’s really important both here and overseas is good training and mentoring for researchers, and vigilant oversight from ethics boards.