Clinical Researcher—July 2021 (Volume 35, Issue 5)

OVER THE TRANSOM

Gary W. Cramer

 

When I read the words of the headline above, I hear them in the ominous voice of a bad guy from the opening credits of the old British TV series, “The Prisoner.” In that rather grim show, Patrick McGoohan played a spy being held in a secret village by anonymous forces using every mind-bending scientific method of an ethically dubious nature under the sun to get him to confess to having some “information” they wanted—all without gaining informed consent, I must add.

However, if our beleaguered hero—who is only ever referred to as “Six” by his captors—ever had such information, he wasn’t about to let on about it, preferring to spend the entire series fighting the powers that be and proclaiming “I am not a number! I am a free man!” Stirring stuff for the 1960s, and still a source of inspiration for modern thrillers.

In our present-day clinical research enterprise, much is said about the value of not treating volunteers for studies as mere numbers or sources of information datapoints. True, more and more emphasis is being placed on patient-reported outcomes when evaluating trial results and on patient-centric input when designing trial protocols, but those are matters of making better use of the resources at hand to improve trial conduct rather than trying to get blood from a turnip, as they say.

In that spirit, here are some excerpts from recent news items that crossed my desk about how various organizations are taming information for their own aims in the pursuit of more efficient and rewarding research and development projects (no endorsements implied).

Clinical Translational Science Center Awarded Grant Renewal From NIH

The UC Davis Clinical Translational Science Center (CTSC) has received notice of its third National Institutes of Health (NIH) award renewal. The five-year award, almost $33 million, comes from NIH’s National Center for Advancing Translational Science. It provides critical funding to CTSC to continue its essential services for the UC Davis research community.

In 2006, UC Davis received one of the first 12 NIH Clinical and Translational Science Awards in the nation to establish a center for clinical and translational science. The center supported the full spectrum of translational research (from bench to bedside to dissemination and implementation). It served as a hub for researchers promoting human health. In 2011 and 2016, the CTSC was successfully renewed.

With institutional support to augment NIH grant funding, the CTSC promotes translational research at UC Davis by:

• Training and cultivating the workforce
• Engaging patients and communities in every phase of the translational process
• Supporting the integration of special and underserved populations in research across the human lifespan to promote health equity
• Innovating processes to increase the quality and efficiency of research, particularly of multisite trials
• Advancing the use of cutting-edge informatics

CTSC fosters trainee and scholar success at all career stages. For example, it manages KL2 awards in support of highly qualified junior faculty conducting mentored, multidisciplinary, patient-oriented clinical research. The CTSC also facilitates better health among underserved rural communities, such as the San Juaquin Valley.

In 2020, the center pivoted to provide specialized support to research teams conducting studies on coronavirus. It enhanced access to digital health data, helped recruit participants, provided regulatory support, and implemented protocols for many of the COVID-related clinical trials.

Reviewing the Top Clinical Research Technology Trends in 2021

According to a recent blog by Florence Healthcare, “If you want to understand the latest trends in clinical research and the direction the industry is headed, the Association of Clinical Research Professionals is always a reliable resource.” That’s why Florence attended ACRP’s virtual Operational Efficiencies Conference in May 2021 and assembled some key takeaways about how clinical research sites adapted to a post-COVID world and how technology can make trials more efficient through eConsent, eSource, and remote monitoring, including the following:

• Decentralized clinical trials that use technology to collect data are convenient for patients and effective for sponsors, contract research organizations (CROs), and research sites. However, it’s important to consider which interactions should take place in person and which should be online.
• Sponsors and sites crave technology that’s intuitive, but they also want vendors to provide customer support and training on an as-needed basis. Technology providers should be able to tell users what ongoing support they offer beyond the implementation process.
• An informal poll taken during a presentation from Florence showed that 28% of attendees already had eRegulatory in place, while 38% were evaluating systems and 34% still used paper. Meanwhile, a Tufts Center for the Study of Drug Development survey showed that 63% of sponsors, CROs, and sites anticipated strong use of eConsent post-pandemic, while 56% expected strong use of eSource and 55% expected strong use of remote monitoring.
• Decentralized trials and remote work became far more common during the pandemic, but these trends aren’t going away. With the worst ravages of COVID-19 behind us, clinical trial professionals can now focus on which aspects of remote technology have worked and which need to be improved so they can keep moving toward a more efficient, patient-focused clinical trial industry.

How Low Healthcare Usage and Trust are Tied to Likelihood of Trial Participation

Writing for SubjectWell recently, Ivor Clarke noted that, “Quality care in any healthcare system relies heavily on patients developing and maintaining trust in their healthcare professionals (HCPs). As we’ve witnessed throughout the COVID-19 pandemic, local HCPs informing and guiding patients on proper treatment and preventive measures were more successful than similar messages pushed from government agencies or medical institutions.” However, while patient trust in HCPs is essential in delivering proper treatment, Clarke wrote that trust does not necessarily extend to positive sentiments regarding clinical research.

In May 2021, SubjectWell polled 892 respondents from South Africa, Canada, and the United States on the topic of healthcare usage, trust, and clinical trial participation. Among the more curious findings from the poll, lower healthcare usage and lower trust in HCPs correlated to higher likelihood of trial participation.

“When we took a closer look at the likelihood of clinical trial participation between countries, South Africa, the country with the lowest HCP visitation rates and lowest overall trust in the healthcare system, responded with the highest likelihood of clinical trial participation at 64%” for a trial unrelated to COVID-19, Clarke wrote. That compared to 59% saying the same in Canada and 54% in the U.S. Similarly, lower healthcare usage and lower trust in HCPs correlated to higher confidence in finding a relevant clinical trial.

To request a download of the complete survey data, visit www.subjectwell.com/surveys.

Company Secures $4 Million to Expand Availability and Adoption of AI-Powered Platform

In June, BEKHealth announced $4 million in funding to accelerate the adoption of the company’s clinical research software platform. BEKHealth’s artificial intelligence (AI)-powered platform aims to accelerate and improve clinical research processes by combining electronic medical record data processing, feasibility and site selection, precision patient trial matching, and care coordination. The company says its AI models combine more than 400 unique medical libraries and 70,000 research protocols with an interoperable clinical data model to power its clinical research software platform.

Powering COVID-19 Studies with a Global Decentralized Clinical Trial Platform

Castor, a provider of clinical trial technology, announced in late May continued rapid adoption of its free decentralized clinical trial platform for COVID-19 research projects. The company says it is supporting more than 250 COVID-19 studies in 40 countries across 1,750 hospitals. 62,000 participants are enrolled in these trials and more than 139 million datapoints have been captured. The company has also developed pre-built electronic case report forms based on World Health Organization (WHO) standards, to help researchers start their study or registry in less than an hour and saw emergency COVID-19 projects go live within 6.5 days on average. One example of a study powered by the eClinical suite is WHO’s Solidarity trial, the largest adaptive COVID-19 clinical trial ever conducted, and one of the largest international randomized trials for COVID-19 treatments, having enrolled more than 13,000 patients in 500 hospital sites in more than 30 countries as of the company’s announcement.

Scaling Up eConsent

Circling back to this issue’s theme on informed consent, Signant Health shared six important factors to keep in mind when implementing eConsent at scale across drug development portfolios in a recent article. “The benefits of eConsent are well understood,” the article notes, “and regulatory questions [are] very addressable by good solutions with flexible features. Greater benefits can be observed by scaling the use of eConsent from select studies to use across the portfolio.”

Gary W. Cramer (gcramer@acrpnet.org) is Managing Editor for ACRP.