A Canadian rheumatology research consortium shuts down, leaving behind a long list of reasons to change the way new-drug trials are conducted and managed.
Pope JE, Thorne JC, Haraoui BP et al. Arthritis Clinical Trials at a Crossroad. The Journal of Rheumatology 2014;42:14-17. doi: 10.3899/jrheum.140717
Galloway JB and Scott DL. Delivering Future Clinical Trials in Rheumatology. The Journal of Rheumatology 2014;42:18-10. doi: 10.3899/jrheum.141270
The Canadian Rheumatology Research Consortium (CRRC), a 21-year-old nonprofit network of rheumatologists conducting clinical trials of new drug treatments for arthritis, has thrown in the towel.
Its lengthy "farewell note", and a separate reflection from two English rheumatologists, lay out plainly the factors that have led to chronic uncertainty about the best treatments for rheumatic disorders.
Warning in an editorial of the "demise of pharmaceutical company inflammatory arthritis clinical trials,", notable CRRC members including rheumatologists Edward Keystone MD of the University of Toronto and Janet Pope MD of Western University in London, Ontario, say that pharmaceutical-funded research as currently conducted is "not feasible" for many sites.
One problem: Many young rheumatologists aren't willing to take on the financial and bureaucratic burdens involved.
Obstacles to effective rheumatology drug-treatment research are not limited to Canada or to rheumatology, the CRRC authors assert. These include the facts that:
• Study cohorts usually don't represent the patient populations in most rheumatology practices;
• Protocols don't reflect current typical practice standards;
• Joining a trial is often a money-losing proposition for rheumatologists, in part because of increased insurance costs;
• Many trials are outsourced to global clinical research organizations (CROs) that lack sufficient knowledge about rheumatology;
Large drug trials have "revolutionized" rheumatology, observe two rheumatologists from the UK in a companion editorial, ushering in biologic treatments and combinations of disease-modifying drugs, along with a focus on early treatment. But they say the CRRC is not just "crying wolf:" The situation in their country is similar.
Conducting many trials in nations with fewer regulatory demands, they add, has created a dilemma: "[N]ew treatments being mainly investigated in one group of patients but predominantly prescribed in another" so that their relevance in North America or the UK is dubious.
This situation should become a "springboard for new initiatives," the UK rheumatologists say, suggesting that:
1. Pharmaceutical firms should be obligated to ensure that their research generates some evidence for efficacy in the populations likely to be treated with their new drugs.
2. Healthcare funders (e.g. governments and insurers) should fund more research into clinical effectiveness.
3. Governance and oversight of trials needs to be "realistic and affordable."
(They don't offer any further suggestions for achieving this.)