Patient-derived determinants for participation in placebo-controlled clinical trials for fibromyalgia.
Perspectives of patients with fibromyalgia influence their likelihood of participating in randomized placebo-controlled trials and potentially clash with current, well-established methodology of randomized controlled trial design. Mandates to use only acetaminophen for breakthrough pain and that require discontinuation of concomitant medications, especially in studies lacking an active comparator arm, could bias a trial cohort to thereby reduce the generalizability of study findings and conclusions. This study evaluates factors affecting willingness to participate in such clinical trials, including the impact of altruism, payment, study duration, forced discontinuation of specific medications, and subject demographics for patients seen by rheumatologists proficient and avidly interested in treating fibromyalgia.
Holman
Andrew J
AJ
Pacific Rheumatology Research, 4300 Talbot Road South, Renton, WA 98055, USA. AJHSeattle@aol.com
Neradilek
Moni Blazej
MB
Dryland
David D
DD
Neiman
Richard A
RA
Brown
Paul B
PB
Ettlinger
Robert E
RE
D000700:Analgesics / Q000627:therapeutic use; D003625:Data Collection; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D010358:Patient Participation / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D000700:Analgesics