Risk-based quality management ‘perfect’ for DCTs: CluePoints

Adoption of decentralized trials is on the rise—and with that increase comes growing awareness of the need for evolved solutions around data collection, patient safety, and other aspects of DCTs. John Hall, senior vice president for EMEA/AsiaPac with CluePoints, shared a sneak peek of some of the topics likely to emerge during his SCOPE 2022 presentation, “Delivering Successful Decentralized Trials - How RBQM and Centralized Monitoring Can Maximize Data Quality” (scheduled Tuesday, February 8, at 12:30 pm EST).

OSP: How have things been at your organization—what changes have taken place since the last SCOPE?​

JH: Over the last 12 months, we have seen an acceleration in the adoption of our services and technology to support the ongoing conduct of clinical trials throughout the pandemic. Our technology has been used to support centralized and remote methods of monitoring study quality, as on-site monitoring has been severely restricted during the pandemic. In addition, our technology has facilitated sponsors to evaluate new risks that have arisen because of the COVID pandemic and enact clear and effective plans to address those challenges.

We have also been very active in supporting the development of new vaccines and treatments for COVID-19. Most notably, we have been recognized by the Scrip Awards for our work together with Pfizer and BioNTech on their Phase I/II/III study of the SARS-COV-2 RNA vaccine BNT162b2 (Comirnaty).

This year, CluePoints is also celebrating its 10th anniversary, supporting the industry to adopt, implement, and scale risk-based approaches to central monitoring and oversight of data quality.

OSP: Coming on year two of the pandemic, what do you think clinical trial professionals have learned about decentralized trials? ​

JH: COVID-19 threatened study continuity and delayed the start-up for new studies. Patients could not visit clinical trial sites, and CRAs could not perform on-site monitoring visits. As a result, clinical trial sponsors enacted continuity plans to enable the continuation of trial conduct and ensure patient safety.

One of the most significant learnings of the pandemic has been around the enactment of such continuity plans and the adoption of DCT and risk-based quality management (RBQM) platform technologies to support the remote collection and monitoring of clinical trial data. Industry surveys have reported that around 76% of surveyed representatives implemented decentralized approaches during the COVID-19 pandemic. A similar number reported implementing or having already fully adopted RBQM. 

As a result of the pandemic, we have further demonstrated these technologies can successfully support clinical trial execution and regulatory approval for new therapies while delivering further benefits over conventional site-based trials. Such benefits include improved patient engagement, diversity and retention, improved trial resilience and improved data quality, lower development costs, and shorter timelines.

Furthermore, we experienced that organizations that had fully embraced RBM before the onset of the pandemic were better positioned to respond to the challenges presented by COVID-19. As a result, now, several pharmaceutical sponsors view these two technologies as the future default mode for conducting clinical research.

OSP: As you hinted, patient safety concerns don’t go away when shifting from on-site studies—how do patient safety challenges change from on-site to DCT or hybrid?​

JH: Challenges in ensuring patient safety in a decentralized or hybrid clinical trial can arise as we devolve the accountability for data collection and administration of study drugs outside the control of a conventional clinical site.

In decentralized trials, we engage new entities such as home healthcare providers, caregivers, local pharmacies, and the patient themselves to be sources for key trial activities and data collection. However, these entities arguably have less structure and oversight compared to conventional clinical sites. Therefore, there is perhaps a more significant opportunity for increased variability to arise in how we collect our data which could introduce risk in ensuring patient safety.

OSP: Similarly, how do data quality concerns change when going to DCT?​

JH: Like patient safety, data quality risks could arise as we engage new independent entities to be sources of study activity and data collection that could impact data reliability. This challenge is perhaps more significant in some DCTs collecting large volumes of data frequently from trial participants, thus requiring the oversight of millions if not billions of data points. 

Additionally, one of the key benefits of decentralized trials is offering trial participants optionality and choosing the route through which they wish to engage with the trial, whether through a physical clinical site or different methods of remote engagement. However, as we provide that optionality to patients within our trials, one key question is, are we potentially adding bias to our critical data across these different modes of data capture?

OSP: Please tell us a bit about RBQM and centralized monitoring—how can such solutions improve data quality, patient safety, and other areas?​

JH: RBQM is an approach to proactively monitor and ensure data quality and patient safety in clinical research. Rather than reviewing every data point collected in a trial, it provides a framework for study teams to focus on the most critical data.

RBQM, in many ways, is a perfect complement to decentralized trial approaches. It provides a framework to evaluate what matters most to data quality and patient safety and to evaluate the trial-specific risks that could impact these. It also provides the tools to enable effective control of such risks so that any issues can be detected and addressed as early as possible and ensure they don’t propagate through the trial. 

In addition, given the large volumes of data we are potentially collecting in decentralized trials, data surveillance tools are even more critical to ensuring we have proper oversight of data quality.

OSP: What are some of the questions a site/sponsor should ask when looking at RBQM/centralized monitoring solutions for decentralized trials?​

JH: Referring to the earlier point around providing trial participants with optionality, one of the critical questions is, How can RBQM solutions enable adequate oversight of variability across different modes of trial engagement and data capture provided to trial participants?

Additionally, in the setting where trial activity is no longer centered around a physical clinical site, it is essential to consider how can RBQM and centralized monitoring tools provide effective oversight of different dimensions of risk and sources of study activity being deployed in a decentralized study, such as home health care nurses and local pharmacies.

The 2022 Summit for Clinical Ops Executives is scheduled February 7-10, in Orlando, Florida, and online. For more information or to register, visit www.scopesummit.com​.​