Reinventing Inflammatory Bowel Disease (IBD) Clinical Trial Recruitment Using Novel Digital Medicine Tools (Preprint)

BACKGROUND Issues with patient recruitment and enrollment are the primary barriers for missed clinical trial timelines; 8 out of 10 clinical trials are delayed or unable to be completed because of lack of timely patient recruitment. Current patient recruitment efforts are inefficient and time-consuming, since they are typically dependent on manually screening patients during face-to-face visits to the clinic or hospital. With the rapid development of digital communication platforms within health care and the broad consumer adoption of smartphones, there are increasing opportunities to overcome some of these barriers. These platforms have particularly great potential for research and clinical care of chronic conditions, such as inflammatory bowel disease (IBD), an often debilitating disease which currently affects over three million adults in the United States. OBJECTIVE To integrate and utilize a digital medicine platform to improve patient recruitment and enrollment processes in clinical trials. METHODS Patients enrolled in the Mount Sinai Crohn’s and Colitis Registry (MSCCR) were remotely approached about enrolling in a mindfulness study for IBD patients. A text-based clinical rules engine was used to inform registry patients about the trial and to allow patients to indicate interest in participating via text message. Eligible IBD patients were bulk “prescribed” a notification through RxHealth’s digital medicine platform, RxUniverse. Characteristics of the enrolled population, characteristics of patients who responded, and timeliness of responses were analyzed. RESULTS Of the 1364 patients in the MSCCR with available phone numbers, 270 patients affirmatively replied they wanted to participate in to the study. Patients who opted into receiving more information about the study were more likely to have inadequate control of their IBD (25.64% vs 18.97%; P<.05) and more likely to have a recent history of depression based on a validated patient health questionnaire (15.38% vs 8.4%; P<.05) than those who opted out. Furthermore, patients who opted in tended to be younger, were more likely to be female, and less likely to have ulcerative colitis, though these trends did not reach statistical significance. Patient race did not significantly differ between those who opted in and opted out. In terms of timeliness of response among those enrolled, the majority of patients responded within 2 hours of notification. CONCLUSIONS Digital medicine software platforms can facilitate large-scale, lower-effort recruitment of eligible patients for clinical trials. Future research should be done to explore their expanded use for recruitment, patient education, and study data collection. Additional technologies such as patient-powered networks, social media, e-recruiting bots, and other remote engagement platforms can aid clinical trials by saving time and reducing costs of patient recruitment.

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REINVENTING INFLAMMATORY BOWEL DISEASE (IBD) CLINICAL TRIAL RECRUITMENT USING NOVEL DIGITAL MEDICINE TOOLS

Inflammatory Bowel Diseases ◽

10.1093/ibd/izaa347.017 ◽

2021 ◽

Vol 27 (Supplement_1) ◽

pp. S7-S7

Author(s):

Farah Fasihuddin ◽

Nicole Wedel ◽

Ashish Atreja ◽

Divya Madisetty ◽

Charu Madhwani Jain ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Bowel Disease ◽

Rapid Development ◽

The United States ◽

Population Characteristics ◽

Patient Recruitment ◽

Digital Medicine ◽

Inflammatory Bowel

Abstract Background Issues with patient recruitment and enrolment are the primary barriers for missed clinical trial timelines; 8 out of 10 clinical trials are delayed or unable to be completed because of the lack of timely patient recruitment. Current patient recruitment efforts are inefficient as they are typically dependent on the manual screening of patients during face-to-face visits. With the rapid development of digital communication platforms within healthcare and the broad consumer adoption of smartphones, there are increasing opportunities to overcome some of these barriers. Digital platforms have great potential for research and clinical care of chronic conditions, such as inflammatory bowel disease (IBD), an often debilitating disease that currently affects over three million adults in the United States. In this paper, we utilized a digital medicine platform (Trialengage, Rx.Health, New York, NY) to improve patient recruitment for an ongoing mindfulness trial which had limited success in face-face enrolment (16 patients over 6 months). Methods Patients enrolled in the Mount Sinai Crohn’s and Colitis Registry (MSCCR) were remotely outreached about enrolling in a mindfulness study for IBD patients. A text-based clinical rules engine was used to inform registry patients about the trial and to allow patients to indicate interest in participating via text message. Eligible IBD patients were bulk “prescribed” a notification through RxHealth’s digital medicine platform, RxUniverse. Characteristics of the enrolled population, characteristics of patients who responded, and timeliness of responses were analyzed. Results Of the 1364 patients in the MSCCR with available phone numbers, 270 patients affirmatively replied they wanted to participate in the study. Patients who opted-in to receiving more information about the study were more likely to have inadequate control of their IBD (25.64% vs 18.97%; P<.05) and more likely to have a recent history of depression based on a validated patient health questionnaire (15.38% vs 8.4%; P<.05) than those who opted-out. There were no significant differences in terms of race, gender, and age between the two groups. In terms of timeliness of response among those enrolled, the majority of patients responded within 2 hours of notification. Conclusion Digital medicine software platforms can facilitate large-scale, lower-effort recruitment of eligible patients for clinical trials. Future research should be done to explore their expanded use for recruitment, patient education, and study data collection. Additional technologies such as patient-powered networks, social media, e-recruiting bots, and other remote engagement platforms can aid clinical trials by saving time and reducing costs of patient recruitment.

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REINVENTING INFLAMMATORY BOWEL DISEASE (IBD) CLINICAL TRIAL RECRUITMENT USING NOVEL DIGITAL MEDICINE TOOLS

Gastroenterology ◽

10.1053/j.gastro.2021.01.054 ◽

2021 ◽

Vol 160 (3) ◽

pp. S10

Author(s):

Farah Fasihuddin ◽

Nicole Wedel ◽

Ashish Atreja ◽

Divya Madisetty ◽

Charu Madhwani Jain ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Trial Recruitment ◽

Digital Medicine ◽

Inflammatory Bowel ◽

Clinical Trial Recruitment

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P051 Use of digital technology to boost patient recruitment in inflammatory bowel disease clinical trials

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx002.177 ◽

2017 ◽

Vol 11 (suppl_1) ◽

pp. S103-S104

Author(s):

Y. Bouhnik ◽

A. Amiot ◽

A. Nuzzo ◽

A. Attar ◽

P.K. Kondamudi ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Bowel Disease ◽

Digital Technology ◽

Patient Recruitment ◽

Inflammatory Bowel

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Preferences of Adult Patients With Inflammatory Bowel Disease for Attributes of Clinical Trials: Evidence From a Choice-Based Conjoint Analysis

Crohn's & Colitis 360 ◽

10.1093/crocol/otz048 ◽

2019 ◽

Vol 2 (1) ◽

Cited By ~ 1

Author(s):

Dallas Wood ◽

Katherine Kosa ◽

Derek Brown ◽

Orna G Ehrlich ◽

Peter D R Higgins ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Bowel Disease ◽

Latent Class ◽

Open Label ◽

Monetary Compensation ◽

Open Label Extension ◽

Inflammatory Bowel ◽

New Treatments

Abstract Background Clinical trial recruitment is the rate-limiting step in developing new treatments. To understand inflammatory bowel disease (IBD) patient recruitment, we investigated two questions: Do changes in clinical trial attributes, like monetary compensation, influence recruitment rates, and does this influence differ across subgroups? Methods We answered these questions through a conjoint survey of 949 adult IBD patients. Results Recruitment rates are influenced by trial attributes: small but significant increases are predicted with lower placebo rates, reduced number of endoscopies, less time commitment, open label extension, and increased involvement of participant’s primary GI physician. A much stronger effect was found with increased monetary compensation. Latent class analysis indicated three patient subgroups: some patients quite willing to participate in IBD trials, some quite reluctant, and others who can be persuaded. The persuadable group is quite sensitive to monetary compensation, and payments up to US$2,000 for a 1-year study could significantly increase recruitment rates for IBD clinical trials. Conclusions This innovative study provides researchers with a framework for predicting recruitment rates for different IBD clinical trials.

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Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments

Gut ◽

10.1136/gutjnl-2020-320690 ◽

2020 ◽

pp. gutjnl-2020-320690

Author(s):

Klaus Gottlieb ◽

Marco Daperno ◽

Keith Usiskin ◽

Bruce E Sands ◽

Harris Ahmad ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Bowel Disease ◽

Statistical Power ◽

Scoring Systems ◽

Academic Community ◽

Theory And Practice ◽

Outcome Instrument ◽

Inflammatory Bowel

Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.

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P039 REINVENTING INFLAMMATORY BOWEL DISEASE (IBD) CLINICAL TRIAL RECRUITMENT USING NOVEL DIGITAL MEDICINE TOOLS

Inflammatory Bowel Diseases ◽

10.1093/ibd/izy393.044 ◽

2019 ◽

Vol 25 (Supplement_1) ◽

pp. S19-S20 ◽

Cited By ~ 1

Author(s):

Emamuzo Otobo ◽

Chris Park ◽

Jason Rogers ◽

Farah Fasihuddin ◽

Shashank Garg ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Trial Recruitment ◽

Digital Medicine ◽

Inflammatory Bowel ◽

Clinical Trial Recruitment

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P039 REINVENTING INFLAMMATORY BOWEL DISEASE (IBD) CLINICAL TRIAL RECRUITMENT USING NOVEL DIGITAL MEDICINE TOOLS

Gastroenterology ◽

10.1053/j.gastro.2019.01.091 ◽

2019 ◽

Vol 156 (3) ◽

pp. S28 ◽

Cited By ~ 1

Author(s):

Emamuzo Otobo ◽

Chris Park ◽

Jason Rogers ◽

Farah Fasihuddin ◽

Shashank Garg ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Trial Recruitment ◽

Digital Medicine ◽

Inflammatory Bowel ◽

Clinical Trial Recruitment

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Reversing the Tide: Improving the Recruitment of Patients With Inflammatory Bowel Disease in Clinical Trials in the United States

Crohn's & Colitis 360 ◽

10.1093/crocol/otaa021 ◽

2020 ◽

Vol 2 (2) ◽

Author(s):

Parakkal Deepak

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Bowel Disease ◽

The United States ◽

Community Settings ◽

Monitoring Methods ◽

Innovative Methods ◽

Inflammatory Bowel ◽

Social Media Tools ◽

Use Of Social Media

Abstract While the number of inflammatory bowel disease (IBD) clinical trials has been increasing, there is decreasing participation in these trials with under-representation of younger patients and those with milder disease and in community settings. Innovative methods to increase recruitment and participation through the use of social media tools, apps, electronic medical record-based patient finding algorithms, and remote monitoring methods are suggested.

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Trends and Characteristics of Clinical Trials Participation for Inflammatory Bowel Disease in the United States: A Report From IBD Partners

Crohn's & Colitis 360 ◽

10.1093/crocol/otaa023 ◽

2020 ◽

Vol 2 (2) ◽

Cited By ~ 1

Author(s):

Cole Johnson ◽

Edward L Barnes ◽

Xian Zhang ◽

Millie D Long

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Bowel Disease ◽

Severe Disease ◽

Drug Approval ◽

The United States ◽

Cross Sectional Study ◽

Cross Sectional ◽

Study Results ◽

Inflammatory Bowel

Abstract Background and Aims There are currently several recruitment challenges in randomized controlled trials (RCTs) for inflammatory bowel disease (IBD), which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors that could influence future recruitment strategies. Methods We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an RCT of medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated in an RCT during each calendar year from 2011 to 2018 and accessed Clinicaltrials.gov to determine the number of active RCTs for IBD therapies per year during that same period. Results A total of 14,747 patients with IBD were included in the analysis and 1116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation included following at an academic institution [odds ratio (OR) = 1.8; 95% confidence interval (CI) 1.51–2.04) and age 36–75 (OR = 1.7; 95% CI 1.46–1.92). Patients with Crohn’s disease were more likely to participate than those with ulcerative colitis (OR = 1.5; 95% CI 1.35–1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR = 2.6; 95% CI 2.19–2.99), IBD-related surgery (OR = 2.5; 95% CI 2.24–2.87), biologic exposure (OR = 3.2; 95% CI 2.76–3.65), and “Poor” or worse quality of life (OR = 1.7; 95% CI 1.45–1.93). Steroid-free remission was associated with a lower likelihood of RCT participation (OR = 0.6; 95% CI 0.53–0.70). Although the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort. Conclusions RCT participation declined within this cohort. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean disease activity scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-tumor necrosis factor (TNF) exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

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