title: Canadian recommendations for clinical trials of pharmacologic interventions in rheumatoid arthritis: inclusion criteria and study design.
abstract: OBJECTIVE
  Current clinical trial designs for pharmacologic interventions in rheumatoid arthritis (RA) do not reflect the innovations in RA diagnosis, treatment, and care in countries where new drugs are most often used. The objective of this project was to recommend revised entry criteria and other study design features for RA clinical trials.
  
  
  METHODS
  Recommendations were developed using a modified nominal group consensus method. Canadian Rheumatology Research Consortium (CRRC) members were polled to rank the greatest challenges to clinical trial recruitment in their practices. Initial recommendations were developed by an expert panel of rheumatology trialists and other experts. A scoping study methodology was then used to examine the evidence available to support or refute each initial recommendation. The potential influence of CRRC recommendations on primary outcomes in future trials was examined. Recommendations were finalized using a consensus process.
  
  
  RESULTS
  Recommendations for clinical trial inclusion criteria addressed measures of disease activity [Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) > 3.2 PLUS ≥ 3 tender joints using 28-joint count (TJC28) PLUS ≥ 3 swollen joint (SJC28) OR C-reactive protein (CRP) or ESR > upper limit of normal PLUS ≥ 3 TJC28 PLUS ≥ 3 SJC28], functional classification, disease classification and duration, and concomitant RA treatments. Additional recommendations regarding study design addressed rescue strategies and longterm extension.
  
  
  CONCLUSIONS
  There is an urgent need to modify clinical trial inclusion criteria and other study design features to better reflect the current characteristics of people living with RA in the countries where the new drugs will be used.
authors.affiliation: The Ottawa Hospital, Riverside Campus, 1967 Riverside Drive, Ottawa, ON K1H 7W9, Canada. jkarsh@ottawahospital.on.ca
authors.forename: Jacob
authors.initials: J
authors.lastname: Karsh
authors.forename: Edward C
authors.initials: EC
authors.lastname: Keystone
authors.forename: Boulos
authors.initials: B
authors.lastname: Haraoui
authors.forename: J Carter
authors.initials: JC
authors.lastname: Thorne
authors.forename: Janet E
authors.initials: JE
authors.lastname: Pope
authors.forename: Vivian P
authors.initials: VP
authors.lastname: Bykerk
authors.forename: Walter P
authors.initials: WP
authors.lastname: Maksymowych
authors.forename: Michel
authors.initials: M
authors.lastname: Zummer
authors.forename: William G
authors.initials: WG
authors.lastname: Bensen
authors.forename: Majed M
authors.initials: MM
authors.lastname: Kraishi
mesh_terms: D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002170:Canada; D002986:Clinical Trials as Topic; D006801:Humans; D018579:Patient Selection; D012107:Research Design