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Reviews on Recent Clinical Trials

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ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

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Research Article

Barriers and Facilitators in Conducting Clinical Trials in Inflammatory Bowel Disease: A Monocentric Italian Survey

Author(s): Tiziana Larussa*, Evelina Suraci, Raffaella Marasco, Maria Imeneo, Dan L. Dumitrascu, Ludovico Abenavoli and Francesco Luzza

Volume 15, Issue 2, 2020

Page: [137 - 144] Pages: 8

DOI: 10.2174/1574887115666200224113520

Price: $65

Abstract

Background: Clinical therapeutic trials are a fundamental tool for identifying and testing new categories of drugs useful for ensuring clinical benefit in patients with Inflammatory Bowel Diseases (IBD). A number of difficulties may affect the recruitment process in large clinical trials.

Objectives: In order to increase the involvement of patients within clinical trials in IBD therapy, it is necessary to identify which factors could facilitate or discourage participation. The aim of this study was to evaluate the factors influencing the participation in clinical trials in a consecutive series of patients with IBD from a single referral center from Southern Italy.

Methods: Consecutive patients with Crohn´s Disease (CD) and Ulcerative Colitis (UC) were recruited to complete a questionnaire dealing with their knowledge about clinical trials and attitudes towards participation. Patients also completed the Short Inflammatory Bowel Disease Questionnaire (S-IBDQ) to investigate their Quality of Life (QoL). Demographic and clinical data were recorded.

Results: Of the 145 consecutive patients invited to the survey, 132 completed the survey (91% response rate). Of them, 67% claimed their willingness to take part in a clinical therapeutic trial for IBD. Multivariate analysis showed a significant positive association between interest in clinical trials and previous experience (p = 0.014), high education (p < 0.001), poor QoL (p = 0.016), money retributions (p = 0.03) and informative materials (p = 0.02). On the other hand, a long-standing disease (p = 0.017), the possibility of receiving a placebo (p = 0.04) and the frequent colonoscopies required by the study protocol (p = 0.04) were significantly associated with the lack of interest in clinical trials.

Conclusion: In a native local resident series of IBD patients, the majority of the patients were willing to participate in a clinical therapeutic trial. A long-standing disease, placebo and invasive procedures represented a barrier to enrollment while previous experience, high education, monetary compensation and adequate information could be facilitative. Knowing barriers and facilitators affecting participation in IBD clinical trials is of fundamental importance in order to increase the involvement of patients in research and explore new treatment opportunities.

Keywords: Clinical trials, Crohn's Disease, health behaviors, inflammatory bowel diseases, patient-centered care, public health, quality of life, ulcerative colitis.

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[1]
Yu YR, Rodriguez JR. Clinical presentation of Crohn’s, ulcerative colitis, and indeterminate colitis: Symptoms, extraintestinal manifestations, and disease phenotypes. Semin Pediatr Surg 2017; 26(6): 349-55.
[http://dx.doi.org/10.1053/j.sempedsurg.2017.10.003] [PMID: 29126502]
[2]
Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol 2015; 12(4): 205-17.
[http://dx.doi.org/10.1038/nrgastro.2015.34] [PMID: 25732745]
[3]
Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology 2004; 126(6): 1504-17.
[http://dx.doi.org/10.1053/j.gastro.2004.01.063] [PMID: 15168363]
[4]
Burisch J, Munkholm P. The epidemiology of inflammatory bowel disease. Scand J Gastroenterol 2015; 50(8): 942-51.
[http://dx.doi.org/10.3109/00365521.2015.1014407] [PMID: 25687629]
[5]
Tursi A, Mocci G, Faggiani R, et al. Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers. Ann Gastroenterol 2019; 32(4): 392-9.
[http://dx.doi.org/10.20524/aog.2019.0377] [PMID: 31263362]
[6]
Tursi A, Mocci G, Faggiani R, et al. Vedolizumab is effective and safe in real-life treatment of inflammatory bowel diseases outpatients: A multicenter, observational study in primary inflammatory bowel disease centers. Eur J Intern Med 2019; 66: 85-91.
[http://dx.doi.org/10.1016/j.ejim.2019.06.006] [PMID: 31208827]
[7]
Quezada SM, McLean LP, Cross RK. Adverse events in IBD therapy: the 2018 update. Expert Rev Gastroenterol Hepatol 2018; 12(12): 1183-91.
[http://dx.doi.org/10.1080/17474124.2018.1545574] [PMID: 30791788]
[8]
Pillai N, Dusheiko M, Burnand B, Pittet V. A systematic review of cost-effectiveness studies comparing conventional, biological and surgical interventions for inflammatory bowel disease. PLoS One 2017 Oct; 3; 12(10) e0185500
[http://dx.doi.org/10.1371/journal.pone.0185500]
[9]
M’Koma AE. Inflammatory bowel disease: An expanding global health problem. Clin Med Insights Gastroenterol 2013; 6: 33-47.
[http://dx.doi.org/10.4137/CGast.S12731] [PMID: 24833941]
[10]
Ma C, Battat R, Dulai PS, et al. Innovations in oral therapies for inflammatory bowel disease. Drugs 2019; 79(12): 1321-35.
[http://dx.doi.org/10.1007/s40265-019-01169-y] [PMID: 31317509]
[11]
Larussa T, Imeneo M, Luzza F. Potential role of nutraceutical compounds in inflammatory bowel disease. World J Gastroenterol 2017; 23(14): 2483-92.
[http://dx.doi.org/10.3748/wjg.v23.i14.2483] [PMID: 28465632]
[12]
Ravikoff JE, Cole EB, Korzenik JR. Barriers to enrollment in inflammatory bowel disease randomized controlled trials: an investigation of patient perspectives. Inflamm Bowel Dis 2012; 18(11): 2092-8.
[http://dx.doi.org/10.1002/ibd.22872] [PMID: 22241674]
[13]
Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: Barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book 2016; 35: 185-98.
[http://dx.doi.org/10.14694/EDBK_156686] [PMID: 27249699]
[14]
Lara PN Jr, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol 2001; 19(6): 1728-33.
[http://dx.doi.org/10.1200/JCO.2001.19.6.1728] [PMID: 11251003]
[15]
Goldman V, Dushkin A, Wexler DJ, et al. Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study. Contemp Clin Trials Commun 2019; 15 100374
[http://dx.doi.org/10.1016/j.conctc.2019.100374] [PMID: 31193095]
[16]
Burisch J, Weimers P, Pedersen N, et al. EpiCom-group. Health-related quality of life improves during one year of medical and surgical treatment in a European population-based inception cohort of patients with inflammatory bowel disease--an ECCO-EpiCom study. J Crohn’s Colitis 2014; 8(9): 1030-42.
[http://dx.doi.org/10.1016/j.crohns.2014.01.028] [PMID: 24560877]
[17]
Hlavaty T, Persoons P, Vermeire S, et al. Evaluation of short-term responsiveness and cutoff values of inflammatory bowel disease questionnaire in Crohn’s disease. Inflamm Bowel Dis 2006; 12(3): 199-204.
[http://dx.doi.org/10.1097/01.MIB.0000217768.75519.32] [PMID: 16534421]
[18]
Jowett SL, Seal CJ, Barton JR, Welfare MR. The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am J Gastroenterol 2001; 96(10): 2921-8.
[http://dx.doi.org/10.1111/j.1572-0241.2001.04682.x] [PMID: 11693327]
[19]
Lönnfors S, Vermeire S, Greco M, Hommes D, Bell C, Avedano L. IBD and health-related quality of life -- discovering the true impact. J Crohn’s Colitis 2014; 8(10): 1281-6.
[http://dx.doi.org/10.1016/j.crohns.2014.03.005] [PMID: 24662394]
[20]
Calvet X, Argüelles-Arias F, López-Sanromán A, et al. Patients’ perceptions of the impact of ulcerative colitis on social and professional life: Results from the UC-LIFE survey of outpatient clinics in Spain. Patient Prefer Adherence 2018; 12: 1815-23.
[http://dx.doi.org/10.2147/PPA.S175026] [PMID: 30271125]
[21]
Na SY, Moon W. Perspectives on current and novel treatments for inflammatory bowel disease. Gut Liver 2019; 13(6): 604-16.
[http://dx.doi.org/10.5009/gnl19019] [PMID: 31195433]
[22]
Randell RL, Long MD, Martin CF, et al. Patient perception of chronic illness care in a large inflammatory bowel disease cohort. Inflamm Bowel Dis 2013; 19(7): 1428-33.
[http://dx.doi.org/10.1097/MIB.0b013e3182813434] [PMID: 23574758]
[23]
Orozco-Beltrán D, de Toro J, Galindo MJ, et al. Healthcare experience and their relationship with demographic, disease and healthcare-related variables: A cross-sectional survey of patients with chronic diseases using the IEXPAC scale. Patient 2019; 12(3): 307-17.
[http://dx.doi.org/10.1007/s40271-018-0345-1] [PMID: 30430456]
[24]
Danese S, Allez M, van Bodegraven AA, et al. Unmet medical needs in ulcerative colitis: An expert group consensus. Dig Dis 2019; 37(4): 266-83.
[http://dx.doi.org/10.1159/000496739] [PMID: 30726845]
[25]
Barnes EL, Long MD, Kappelman MD, Martin CF, Sandler RS. High patient activation is associated with remission in patients with inflammatory bowel disease. Inflamm Bowel Dis 2019; 25(7): 1248-54.
[http://dx.doi.org/10.1093/ibd/izy378] [PMID: 30590700]
[26]
Daperno M, Bortoli A, Kohn A, et al. Italian Group for the study of Inflammatory Bowel Disease IG-IBD. Patient and physician views on the quality of care for inflammatory bowel disease after one-year follow-up: Results from SOLUTION-2, a prospective IG-IBD study. Dig Liver Dis 2017; 49(9): 997-1002.
[http://dx.doi.org/10.1016/j.dld.2017.05.008] [PMID: 28595949]
[27]
Bezzio C, Imperatore N, Armuzzi A, et al. Italian Group for Inflammatory Bowel Disease (IG-IBD). Unmet needs of Italian physicians managing patients with inflammatory bowel disease. Dig Liver Dis 2019; 51(2): 212-7.
[http://dx.doi.org/10.1016/j.dld.2018.07.041] [PMID: 30228075]
[28]
Marín-Jiménez I, Casellas F, Cortés X, et al. The experience of inflammatory bowel disease patients with healthcare: A survey with the IEXPAC instrument. Medicine (Baltimore) 2019; 98(14) e15044
[http://dx.doi.org/10.1097/MD.0000000000015044] [PMID: 30946348]
[29]
Gehrmann U, Berger U, Teich N, Bruns T, Stallmach A, Weber M. Motivation of patients with inflammatory bowel disease to participate in a clinical trial. Z Gastroenterol 2016; 54(10): 1123-9.
[http://dx.doi.org/10.1055/s-0042-105749] [PMID: 27723903]
[30]
Cottone M, Criscuoli V, Modesto I, Orlando A. Methodological problems in RCTs on IBD. Rev Recent Clin Trials 2012; 7(4): 284-9.
[PMID: 23092230]
[31]
Lee E, Shafer LA, Walker JR, et al. Information experiences, needs, and preferences of colonoscopy patients: A pre-colonoscopy survey. Medicine (Baltimore) 2019; 98(20) e15738
[http://dx.doi.org/10.1097/MD.0000000000015738] [PMID: 31096537]
[32]
Shah R, Hou JK. Approaches to improve quality of care in inflammatory bowel diseases. World J Gastroenterol 2014; 20(28): 9281-5.
[PMID: 25071321]
[33]
Noiseux I, Veilleux S, Bitton A, et al. Inflammatory bowel disease patient perceptions of diagnostic and monitoring tests and procedures. BMC Gastroenterol 2019; 19(1): 30.
[http://dx.doi.org/10.1186/s12876-019-0946-8] [PMID: 30760205]
[34]
Kuenzig ME, Lee L, El-Matary W, et al. The impact of inflammatory bowel disease in Canada 2018: Indirect costs of IBD Care. J Can Assoc Gastroenterol 2019; 2(Suppl. 1): S34-41.
[http://dx.doi.org/10.1093/jcag/gwy050] [PMID: 31294383]
[35]
Guedj M, Ballester S, Kamar N, et al. Patients’ motives for consenting or refusing to participate in a clinical trial in organ transplantation. Clin Transplant 2013; 27(5): 724-31.
[http://dx.doi.org/10.1111/ctr.12214] [PMID: 24033357]
[36]
Udrea G, Dumitrescu B, Purcarea M, Balan I, Rezus E, Deculescu D. Patients’ perspectives and motivators to participate in clinical trials with novel therapies for rheumatoid arthritis. J Med Life 2009; 2(2): 227-31.
[PMID: 20108545]
[37]
Trauth JM, Musa D, Siminoff L, Jewell IK, Ricci E. Public attitudes regarding willingness to participate in medical research studies. J Health Soc Policy 2000; 12(2): 23-43.
[http://dx.doi.org/10.1300/J045v12n02_02] [PMID: 11184441]
[38]
Hussain-Gambles M. South Asian patients’ views and experiences of clinical trial participation. Fam Pract 2004; 21(6): 636-42.
[http://dx.doi.org/10.1093/fampra/cmh611] [PMID: 15528290]
[39]
Al-Dakhil LO, Alanazy R, AlHamed RE, Al-Mandeel H, Alobaid A. Attitudes of Patients in Developing Countries Toward Participating in Clinical Trials: A Survey of Saudi Patients Attending Primary Health Care Services. Oman Med J 2016; 31(4): 284-9.
[http://dx.doi.org/10.5001/omj.2016.55] [PMID: 27403241]
[40]
Almutairi AF, Almutairi BM, Alturki AS, et al. Public motives and willingness to participate in first-in-human clinical trials in Saudi Arabia: A new era in the making. J Infect Public Health 2019; 12(5): 673-80.
[http://dx.doi.org/10.1016/j.jiph.2019.03.013] [PMID: 31006634]
[41]
Schilling I, Behrens H, Hugenschmidt C, Liedtke J, Schmiemann G, Gerhardus A. Patient involvement in clinical trials: motivation and expectations differ between patients and researchers involved in a trial on urinary tract infections. Res Involv Engagem 2019; 5: 15.
[http://dx.doi.org/10.1186/s40900-019-0145-3] [PMID: 30984414]

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