title: Improving participation in clinical trials of novel therapies: going back to basics.
abstract: Clinical trials in many diseases are experiencing more difficulties in achieving sufficient or timely enrollment of participants; anecdotal reports from trials of novel therapies for systemic lupus erythematosus (SLE) seem to be facing the same challenges. General factors associated with this trend include the growth of the contract research industry, increasing oversight, and high-profile accounts of scientific misconduct and fraud in research. Complicated protocols that increase participant burden, overly restrictive entry criteria, the fear of an SLE flare may also affect enrollment in SLE trials.
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea; Department of Aging, Brigham and Women's Hospital, Boston, MA, USA; Section of Rheumatology, VA Healthcare System, Boston, MA, USA.
authors.forename: Chan-Bum
authors.initials: CB
authors.lastname: Choi
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.affiliation: Section of Rheumatology, VA Healthcare System, Boston, MA, USA.
authors.forename: Samar
authors.initials: S
authors.lastname: Gupta
authors.affiliation: Tufts University, Boston, MA, USA.
authors.forename: Malcolm P
authors.initials: MP
authors.lastname: Rogers
authors.affiliation: Section of Rheumatology, VA Healthcare System, Boston, MA, USA. Electronic address: MHLIANG@PARTNERS.ORG.
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Liang
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000523:psychology / Q000639:trends; D003657:Decision Making; D057220:Health Literacy; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy / Q000523:psychology; D010342:Patient Acceptance of Health Care; D010358:Patient Participation / Q000379:methods / Q000523:psychology; D018579:Patient Selection
keywords: Enrollment; Randomized clinical trials; Retention; Systemic lupus erythematosus