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ARE INFLAMMATORY BOWEL DISEASE (IBD) PATIENTS' EXPECTATIONS MET WHEN PARTICIPATING IN THERAPEUTIC DRUG TRIALS? A RETROSPECTIVE CLINICAL STUDY
A Stewart1, D Leddin1, I Epstein2, J Stewart1
1Queen Elizabeth II Health Sciences Centre; 2Dalhousie University, Halifax, Nova Scotia
Aims: The purpose of this study was to determine if patient expectations were met during their participation in an IBD clinical trial and to determine why patients chose to participate.
Methods: Individuals who completed an IBD clinical trial at the QEII Health Sciences Centre from August 2004 to October 2008 were eligible to participate and asked to complete a brief questionnaire during their final study visit.
Results: Data was collected from 93 participants (45 men, 48 women) from 11 clinical trials. The duration of IBD varied among participants from 2 to 39 years (avg 15.6 yrs). The majority of participants were Caucasian between 26-60 years old. 74% of participants had access to a drug plan.
The most common reasons individuals chose to participate were to feel better, physician recommendation, and to receive better care. Receiving better care was significantly more important to 26-40 year olds. Individuals living in a city or rural area placed higher value on doctor recommendations than those living in a town. Side effects and receiving free medication were the least common reasons to participate.
92.5% of respondents were strongly satisfied with the time and care they received from the study coordinator. However many individuals, specifically those with a family income over $40,000, were unsatisfied with the time and care they received from the physician. 87.1% of participants reported that they would likely enroll in a future trial. 76.1% of participants reported that their expectations related to study participation were completely fulfilled.
Conclusions: Potential patients may decide against participating in a clinical trial because of concerns about experimentation, side effects, or the fear of being treated as a 'guinea pig'. This study allows us to reassure patients that satisfaction rates with the level of care received and follow-up in clinical trials is in excess of 80%. Patients who volunteer to take part in clinical trials tend to be well informed and highly motivated. Patients are generally more satisfied with the care received from the study coordinators opposed to the physician - a finding for clinicians to be mindful of when enrolling their patients in clinical trials.