Patient perceptions and barriers to clinical research and trials
Research type
Research Study
Full title
A Questionnaire study exploring patients’ perceptions of clinical research in inflammatory bowel disease and barriers to participating in clinical trials
IRAS ID
311138
Contact name
Jimmy K Limdi
Contact email
Sponsor organisation
Northern Care Alliance NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Inflammatory bowel diseases (IBD), comprising Crohn’s disease and ulcerative colitis are chronic, relapsing and remitting, progressive, immune-mediated conditions affecting the digestive tract.
IBD can be well controlled with current medical and surgical options but is not curable at the present time. The number of people affected by IBD is increasing worldwide but so are the treatment options. Research plays an important role in improving treatment with the aim of controlling inflammation, promoting gut healing and improving overall quality of life. Our most effective treatments achieve clinical remission in approximately 30% of our patients with moderate to severe IBD, indicating an unmet need for more effective therapies.
Numerous clinical trials (on -going and in development) for novel medications aim to address this issue. Research also aims to address important issues such as quality of life among several others. Despite this, the number of people living with IBD participating in clinical research remains low.
This questionnaire study aims to improve our understanding of perceptions around participation in research and clinical trials among people living with IBD in the UK and identify potential barriers to participation in research.
Lay summary of study results: Aims:
1. To explore’ perceptions of research and barriers to participation
2. To assess patient knowledge and awareness of types of research .
3. To explore the concerns around participation in research among.
4. To explore factors that might motivate people to participate in research and references to information.Background:
The rising incidence and prevalence of inflammatory bowel disease (IBD), its uncertain aetiology and multidimensional and negative effects on people’s lives have underscored the importance and need for research across disciplines. Despite this, participation in research in IBD remains relatively low with virtually no data exploring patients’ perceptions and barriers to participation in research among people living with IBD in the UK and little worldwide.Methods:
A focus group of people living with IBD consulted in questionnaire design. Patients with IBD attending clinic visits, endoscopy and transfusion unit, at our centres were invited to complete a questionnaire in person, post back, or electronically. Demographics, disease duration and activity were recorded and perceptions and barriers to participating in research were explored. Logistic regression analysis was conducted using ‘participation’ as a binary outcome. Three separate models using an indication of (a) future participation (b) past participation and (c)participation in a future drug trial as a measure of participation were performed.Key findings:
1165 people living with IBD were approached to complete the questionnaire. 1007 participants were included (143 declined to participate and 15 questionnaires were excluded due to being incomplete).There were similar numbers of men and women (484/1007 48.1%, 514/1007 51.0%, 2 non-binary and 1 prefer not to say. 6 did not answer). The majority of participants identified as ‘White British’ (849/1007 84.3%) with the next largest group being Pakistani (45/1007 4.5%). IBD subgroups had similar numbers of ulcerative colitis and Crohn’s disease (459/1007 45.6%, 485/1007 48.2, 20/1007 2.0% IBD unclassified, 40 patients were unsure of their diagnosis and 3 did not answer). Median age was 35-44 years. The majority of participants (640/1007 63.6%, 20 were not sure and 29 did not answer) were taking or had previously taken an advanced therapy (azathioprine, mercaptopurine, biologic or small molecule inhibitor). 571/1007 (56.7%) participants had been involved in previous research (6 did not answer).
899 participants would participate in future research (2 did not answer) and the majority would participate in a drug trial (564/899 62.7%, 4 did not answer and 1 was not sure). 84.6% (761/899) of people who would participate in future research and 88.5% (499/564) of people who would participate in drug trials identified as White British. 81.1% (86/106) who would not participate in future research and 79.2% (271/342) who would not participate in drug trials identified as White British. People in a White British ethnicity tended to be more likely to participate in drug trials (OR 2.31 (1.56 to 3.20) but there was no evidence of a relationship between ethnicity and participation in research in general. There is some evidence that those who have used advanced therapies either previously or currently would be more likely to participate in future research (OR 1.75 95% CI 1.15 to 2.66)
The most important reasons to participate were ‘to advance medical knowledge’ (564/899 62.3%, 71 did not answer) and ‘the possibility of receiving effective treatment’ (221/899 24.6%). Although not required 276/899 patients answered what dissuades them from research. The most important reasons were ‘concern for their own health’ (97/276 35.1%) and ‘unable to commit the time/travel’ (67/276 24.3%).
Of the 106 patients who wouldn’t participate in further research the most important reasons were ‘unable to commit the time/travel’ (46/106 43.4%, 10 did not answer) and ‘concern for their own health’ (13/106 12.3%).
Whilst only a small percentage of participants rated ‘concern more tests’ and placebo as the most important dissuasion from research participation (17/382 4.5% and 14/382 3.7%) more people not wanting to participate in future research felt ‘more tests’ would deter them than those willing to participate (22/106 20.8%, 31/276 11.2%). Whereas for those willing to participate more people rated the possibility of having a placebo as a deterrent compared to those not interested in research (45/276 16.3%, 5/106 4.7%).
In both groups ‘direct conversation with their doctor’ was the most likely reason to motivate people living with IBD to participate in research (622/1007 61.8%).
Patients demonstrate a high level of interest in IBD research, with two-thirds interested in drug trials. Improved communication is vital to dispel common fears regarding risk and reducing time commitments especially in hospital is an important factor to patients.
REC name
London - Queen Square Research Ethics Committee
REC reference
22/PR/0274
Date of REC Opinion
5 Apr 2022
REC opinion
Further Information Favourable Opinion