This article is more than 5 years old. Information may no longer be current.
Pilot study to assess decentralized data collection for patients with ulcerative colitis
Click Here to Manage Email Alerts
Researchers from Brigham and Women’s Hospital have begun a new ulcerative colitis clinical trial to evaluate the feasibility of replacing clinical site visits with decentralized patient data collection methods, according to a press release.
“Site visits for patient data collection are the most costly and burdensome clinical trial activity,” according to the press release. “The growing availability of remote monitoring technologies reduces the need for site visits,” potentially saving time and money, and increasing patient safety and the quality of clinical data.
The decentralized data collection methods to be compared with conventional methods include digital measurements, telemonitoring, remote video visits with clinical trial staff members and blood collection by visiting nurses. Assessments of key clinical endpoints will be made by participants’ own community gastroenterologists rather than trial investigators using the Mayo Score, a first for a clinical trial, the release said.
“Increasingly, empowered patients and the wide availability of digital monitoring technologies give us the opportunity to reimagine how we conduct clinical trials, with the goal of making them more informative, effective, safe, affordable and inclusive,” Joshua R. Korzenik, MD, director of the Crohn's and Colitis Center, division of gastroenterology, hepatology and endoscopy at Brigham and Women's Hospital, said in the press release. “In addition, we believe that this is the first time that key invasive clinical assessments such as the Mayo Score are being conducted by subjects' own physicians, which saves time and resources, but more importantly, sets the study in the context of patients’ ongoing care. Ulcerative colitis is a disabling condition with limited treatment options, so we welcome the chance to participate in the development of new approaches intended to facilitate clinical development of more drug candidates.”
Participants have been recruited from the open-label Combined Anti-Inflammatory Diet (CAID) study, and will choose to participate in either the conventional on-site arm or the remote, decentralized data collection arm, after which they will be randomly assigned to the CAID or control group.
“Some thought we were starry-eyed optimists to launch a drug development company committed to bringing 21st century approaches to a clinical trial process that had become costly and dysfunctional,” Tomasz Sablinski, MD, PhD, co-founder and CEO of Transparency Life Sciences, which commissioned and funded the study, said in the release. “But we believed that the [Transparency Life Sciences] principles of open innovation and technology-powered stakeholder engagement were ideas whose time had come. Recent successes in advancing this transformational approach are proving us right, as illustrated by initiation of this important pilot study with the help of distinguished collaborators.”
AMC Health contributed to the design of the trial and will also contribute its mobile technology, enabling video study visits and at-home patient vital sign collection, and MedPoint digital will contribute to the trial by helping with the management of patient recruitment, enrollment, electronic informed consent and endoscopy video data storage, the release said.
“People like me who live with inflammatory bowel disease experience many symptoms outside the doctor's office — at home, at work, at the store, and on the go,” Sean Ahrens, activist Crohn's patient and founder of Crohnology.com, said in the release. “If we are going to learn about the real world effects this disease is having on patients, and how best to address them, we need to be recording our symptoms in an ongoing way in decentralized settings.”
Disclosure: Sablinski is an employee of Transparency Life Sciences. Healio Gastroenterology was unable to confirm Korzenik’s relevant financial disclosures at the time of publication.