TY - JOUR T1 - Arthritis Clinical Trials at a Crossroad JF - The Journal of Rheumatology JO - J Rheumatol SP - 14 LP - 17 DO - 10.3899/jrheum.140717 VL - 42 IS - 1 AU - JANET E. POPE AU - J. CARTER THORNE AU - BOULOS P. HARAOUI AU - JACOB KARSH AU - EDWARD C. KEYSTONE AU - LINDA BENNETT Y1 - 2015/01/01 UR - http://www.jrheum.org/content/42/1/14.abstract N2 - With more than a century of combined trial experience, we discuss the demise of pharmaceutical company inflammatory arthritis clinical trials, speaking from our experience in Canada while potentially generalizing to the United States, Western Europe, and other regions where patients have reasonable access to medical care and therapeutics.The purpose of this editorial is 2-fold: to raise awareness of the critical state of rheumatology clinical trials in Canada; and to describe the increasingly insurmountable barriers facing trialists because of difficulty recruiting owing to trial designs (some requiring substandard care for participation); recent changes in trial operations and management; and the financial burden placed on trialists. The challenges are not unique to rheumatology1,2. Many industry-funded trials are not feasible. This can shift investigators to conducting non-pharmaceutical trials to answer challenging important questions, but the trials are usually extremely underfunded, creating a barrier to participation.Traditionally, clinical research has been the only means whereby advances in medicine can be translated into excellent patient care. Trial participation facilitates greater acceptance of innovative treatments and the integration of successful treatments into optimal care. There is no replacement for phase II and III clinical trial experience: Clinical trialists are early adopters and comfortable prescribers of new therapies once they are approved because they have acquired invaluable experience of novel products.In contrast, current trials are mostly bureaucratic and time-consuming to initiate and conduct, and they do not reflect the population studied. In fact, clinical research is becoming increasingly onerous with respect to regulatory and administrative requirements and is very expensive (in people and time resources) while, simultaneously, recruitment has dwindled (years ago, sites could enroll 10 subjects in a study vs 0 to 4 per study today). Thus, incurred costs are not recovered. Moreover, recruitment is limited by trial designs that … Address correspondence to Dr. J.E. Pope, 268 Grosvenor St., London, Ontario N6A 4V2, Canada. E-mail: janet.pope{at}sjhc.london.on.ca ER -