Improving participation in clinical trials of novel therapies: going back to basics

Rheum Dis Clin North Am. 2014 Aug;40(3):553-9, ix. doi: 10.1016/j.rdc.2014.05.002.

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.

Keywords: Enrollment; Randomized clinical trials; Retention; Systemic lupus erythematosus.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials as Topic* / methods
  • Clinical Trials as Topic* / psychology
  • Clinical Trials as Topic* / trends
  • Decision Making
  • Health Literacy
  • Humans
  • Lupus Erythematosus, Systemic* / drug therapy
  • Lupus Erythematosus, Systemic* / psychology
  • Patient Acceptance of Health Care
  • Patient Participation / methods
  • Patient Participation / psychology
  • Patient Selection*