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Abstract
Background Since publication of the top 10 research priorities in inflammatory bowel disease (IBD) based on the James Lind Alliance Priority Setting Partnership, the question remains whether this has influenced the IBD-research landscape. This study aimed to create an overview of the current distribution of research interests of trials in the UK.
Methods The ClinicalTrials.gov database and European Union Clinical Trials Register were screened for clinical trials set up from 9 August 2016 to 16 November 2019 in the UK involving adult patients with IBD.
Results Of 20 non-industry-sponsored studies, a quarter investigated treatment strategies considering efficacy, safety and cost-effectiveness (priority 1). Four evaluated the role of diet (priorities 3 and 7). Development/assessment of biomarkers for patient stratification (priority 2) and fatigue (priority 8) were subject of three studies. IBD-related pain and control of diarrhoea/incontinence were each subject of 2 studies (priorities 4 and 6). The effect of gut microbiota (priority 10) and optimal strategy for perianal Crohn’s disease (priority 5) was the focus of 2 studies each. One study evaluated surgery for terminal ileal Crohn’s disease (priority 9). Of 63 industry-sponsored studies, 59 focused on priority 1.
Conclusions This study presents an impression of the breadth of the IBD-research landscape in the UK, in light of the top 10 research priorities published in 2016. Optimal treatment strategy has been the most studied research priority by academic and industry-sponsored trials. Fewer studies focused on patient-reported outcomes. It remains debatable to what extent the current research landscape adequately represents all stakeholders’ viewpoints on needs for expanded knowledge in IBD, particularly the patients’ perspective.
- IBD
- CROHN'S DISEASE
- ULCERATIVE COLITIS
- CLINICAL TRIALS
Data availability statement
Data are available in a public, open access repository. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Data were extracted from ClinicalTrials.gov and European Union Clinical Trials Register. Please see the 'Methods' from the main manuscript.
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Data availability statement
Data are available in a public, open access repository. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Data were extracted from ClinicalTrials.gov and European Union Clinical Trials Register. Please see the 'Methods' from the main manuscript.
Supplementary materials
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Footnotes
Contributors JG: conducted data collection, wrote and reviewed manuscript, submitted manuscript, J-FL: conducted data collection, wrote and reviewed manuscript. J-FL: conducted data collection, wrote and reviewed manuscript. JS: wrote and reviewed manuscript. CWL: developed study, reviewed manuscript, responsible for the overall content. AH: developed study, reviewed manuscript, responsible for the overall content. Both authors contributed equally as first authors. Both authors contributed equally as last authors
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JG, J-FL, LL: no competing interests. JS: was actively involved in the trial 'STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis. 'CWL: is actively involved in the following trial: 'The PRognostic Effect of Environmental Factors in Crohn’s and Colitis (PREdiCCt)'AL Hart: is actively involved in the following trials:· 'STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis'· 'A supported online self-management tool for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial'.
Provenance and peer review Not commissioned; externally peer reviewed.
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