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Keywords:

  • inflammatory bowel disease;
  • trial design;
  • barriers to enrollment

Abstract

Background:

Despite a sizeable inflammatory bowel disease (IBD) population in the United States, large trials in IBD have difficulty recruiting patients. Reasons for low enrollment are uncertain. Our objective was to investigate specific barriers to enrollment in clinical trials by determining aspects of study design, disease state, demographics, and previous experiences with research that influence a patient's willingness to participate.

Methods:

Patients with Crohn's disease (CD) and ulcerative colitis (UC) at the Massachusetts General Hospital Crohn's and Colitis Center were surveyed.

Results:

Most participants (61%) had participated in some clinical research previously, although 50% of those were not interested in participating in a future study. Frequent doctor visits (69%), requirement of colonoscopy (55%), or sigmoidoscopy (49%), and blinding (46%) were the biggest deterrent study requirements. With each addition of one of these components, potential enrollment fell from 43.2% (86) to 14.6% (29) interested patients. Respondents were likely to participate in studies that were open label (60%), initially randomized then open label (57.6%), or saw the same doctor (52.5%). Among those disinclined to participate, strategies to boost enrollment included monetary compensation, an open-label component, or providing the same doctor at each visit. Men and patients who were currently flaring were more likely to participate.

Conclusions:

Elements of study design negatively and positively influence willingness to participate. Invasive procedures, randomization, and frequent visits negatively influenced willingness to participate and as each of these components are added, a significant additive percent of potential subjects are lost. Strategies to further identify barriers to enrollment within IBD study populations should be pursued. (Inflamm Bowel Dis 2012;)