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The continued exploration of modernizing clinical trials

Monday, May 1, 2017

The need for an alternative to the paper-based clinical trial process is long overdue. Not only is the original method cost- and labor-intensive, but it can delay new drug development, as well. The first siteless technology model for clinical trial research was introduced last year, and since then studies in this area continue.

At the 3rd Annual Clinical Trials Patient Experience Summit, held recently in California, industry leaders discussed the potential impact the changes to a siteless clinical trial model may have on the patient. By focusing on topics such as patient input regarding the potential of remote studies; indication and therapy areas best fit for remote trials; and patient safety and engagement as it pertains to telehealth technology, business leaders in the industry discussed those at the center of this advance in clinical trial innovation—the patient.

“I think patients are generally enthusiastic about remote trials since it decreases the burden of travel and taking time off from work,” said panelist Gabriel Vargas, executive medical director of Digital Health at Amgen.

Vargas noted that with diminished burden of travel and time, patient engagement might actually improve. Conversely, patient engagement may also suffer due to the lack of personal contact. As a result, Vargas recognizes the importance of having patient engagement approaches, such as social media or texting apps, in place as part of the siteless trial model.
“I believe safety can potentially be improved by capturing data on a regular basis and not just during site visits through the use of sensors and wearables,” said Vargas.

Another panelist, Hassan Kadhim, a business consultant with Boehringer Ingelheim Pharmaceuticals, believes the siteless model would benefit patients, but prefers calling it a remote or digital trial.

A remote or digital trial has only one site at its center, as opposed to being multi-centric. As a result, Kadhim explained, a qualified principal investigator would still be involved, which maintains the integrity of the trial and ensures patient safety.

“Anecdotally, a patient participating in the trial without the burden of necessary site visits and trips would seem beneficial,” said Kadhim. He went on to emphasize the need for a holistic approach to patient care during a siteless trial.

“It would be pertinent to have a connection with the patient’s primary care physician during the trial,” Kadhim said. He cited the importance of the primary care physician being aware that his or her patient was participating in the trial, and the need to have access to the patient’s health information.

At this point, all indications point toward patients and potential patients embracing this new approach to clinical trials.

“Patients and patient advocacy groups have long been pushing for greater access to drugs under development and a broader representation of the general health population in clinical trials. It is now widely acknowledged that potential patients are able and willing to provide subjective and objective data in the course of clinical trials via technology,” said Xavier Flinois, Parexel Informatics president.

The industry as a whole continues to examine the siteless CRO model, with webinars and conferences focusing on how to modernize clinical trials, while maintaining patient safety and engagement.

In a recent webinar hosted and sponsored by Center Point Clinical Services, which has positioned itself as the creator of the world’s first siteless CRO platform, the challenges of both patient recruitment and retention in clinical trials were examined. Specifically, access to and the availability of potential participants to the trial site can be challenging. In addition, participants may be unable or unavailable to commit to follow-up. The siteless CRO model is a way to modernize clinical trials, while also offering studies to a broader, more diverse group of participants. This method successfully eliminates excessive travel, while offering a greater number of patients availability and access to studies.

The siteless CRO model is well-suited for a number of therapeutic areas, particularly when patients experience functional challenges with neurodegenerative diseases, such as Parkinson’s disease, Huntington’s disease and Alzheimer’s disease.

“Before, certain patients would not have been able to participate in trials, but the introduction of off-the-shelf technology changes that,” said Joe Martinez, RPh, PDE, PPC, of Center Point Clinical Services.

In March of 2016, Frost & Sullivan published an analysis of the consumer and clinical health wearables market and the associated potential. Frost & Sullivan characterizes the following therapeutic/health areas as representing the majority of the wearables potential: cardiovascular disease, diabetes and obesity, COPD, chronic pain management, neurological and mental health, women’s and pediatric health, sleep disorders and elderly care.

“The collection of clinical data via wearables and sensors has the potential to replace or reduce the number of clinical assessments and/or visits during clinical trials, reducing the burden on patients and sites and decreasing costs,” said Flinois.

As the industry continues to analyze the impact technology has on clinical trials and participating patients, it is hoped the favorable feedback, results and outcomes will lead to a reduction in cost and length of time of drug development and greater access to studies by a broader range of participants.


This article was reprinted from Volume 21, Issue 17, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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