Fully Decentralized Trials: Aspirational Goal Or Reality?

Fully Decentralized Trials: Aspirational Goal Or Reality?

The COVID pandemic accelerated the adoption of decentralized trials at a rate never before experienced throughout the Biopharma industry. Sponsors and CROs who once expressed concerns about possibly losing control in a remote environment welcomed remote trial approaches, especially the use of mobile research nurses to visit patients at home, as a means to save trials that would have otherwise been delayed or canceled entirely as a result of the concerns and restrictions of the pandemic.

Many companies rushed to adapt existing protocols to fit a remote environment and successfully moved forward with hybrid trials that involved physical sites as well as mobile research nurses. Since the peak of the pandemic, the popularity of hybrid approaches has largely remained. However, fully decentralized trials are still somewhat rare. Why?

Misconceptions regarding the challenges of decentralized trials

Despite a myriad of successes, some sponsors remain skeptical about the practicality of remote visits. Concerns most often cited include: lack of control, challenges in maintaining data integrity, and the inability to complete more complex procedures outside of a traditional clinical setting. Often there is also concern about the potential for an added workload if a site is no longer involved to serve as an intermediary to handle the recruiting, informed consent and data entry procedures.

The reality is that, while some of these services like recruiting and garnering consents may be handled differently when disparate physical sites are not fully involved, there are alternatives for completing them efficiently. In some cases, sites such as hospitals can be contracted for use of their recruitment specialists only. Since no medical staff is required from the site, these hospitals recognize an additional revenue stream without having to burden their medical staff. In other instances, a third-party recruiting center may be contracted.

With advances in technology and growing consumer preferences for Internet-based transactions, digital ads are also being effectively used to recruit patients in all 50 states, as well as abroad. E-consents are also becoming the norm as a means to secure patient consent to participate in a trial. In still other instances, the mobile research nurse provider can serve as an extension of the physical sites by handling some of the responsibilities.

The capabilities of today’s mobile research nurses also mean that even complex trials can be completed in a patient’s home. Safeguards are in place such that properly trained mobile research nurses can safely, efficiently, and compliantly complete blood draws, set up central lines, and handle more advanced procedures such as infusions, EKGs, and spirometry diagnostic tests, to name a few procedures.

PCM Trials proves fully decentralized trials are viable: two success stories

PCM Trials, a leading provider of mobile research, has proven that fully decentralized trials are not only possible but also offer a number of unmatched advantages. In an industry where fully decentralized trials are still rare, PCM is actively conducting its second such trial in two years.

Recruitment for PCM’s first fully decentralized trial began in October of 2020 and is expected to be completed within three years from the start date. It is the largest clinical trial—by 10X—ever attempted with Parkinson’s patients. Known as the Trial of Parkinson’s and Zoledronic Acid (TOPAZ), the trial is investigating whether a drug used to treat osteoporosis will reduce bone fractures in patients with Parkinson’s disease. By using PCM’s mobile research nurses, the trial is on track to meet its goal of recruiting 3,700 patients. More than 1,600 participants have already been recruited from all 50 states largely because of the attraction of the more patient-centric decentralized approach which means this highly vulnerable population doesn’t have to leave their home and travel to sites.

The sponsor of TOPAZ chose to use a fully decentralized model that employed certified mobile research nurses from PCM Trials in order to reduce total trial costs and increase diversity in the trial population. Dr. Steven Cummings, executive director of the San Francisco Coordinating Center who leads the trial, estimates a cost savings of 80% per participant compared to what it would have cost to conduct the trial using clinical sites because there is no overhead or staff costs of a clinical site. He is also satisfied with the high level of diversity of patients recruited to date.

In 2022 PCM launched its second fully decentralized trial focused on patients with diabetes. The clinical trial is testing the viability of a novel integrated management system that includes a new app and continuous glucose monitor.

The sponsor chose to go the fully decentralized route to achieve greater cost efficiencies and faster enrollment. PCM Trials screened its first patient in June of 2022 and, by mid-September, had already seen over 100 patients. This type of speedy turnaround can make a real difference for sponsors desiring to bring their trial drugs and devices to market sooner.

From a cost standpoint, the sponsor only has to pay one partner, PCM Trials, vs. paying multiple sites across states in anticipation of successfully recruiting participants. For this particular trial, PCM also hired dedicated data entry specialists to enter study data into an EDC system.

The making of a fully decentralized trial

Given the unique environments of a fully decentralized trial, it’s critical to choose a partner with a track record for successful in-home visits. PCM Trials, for example, is a pioneer in mobile research. Starting in 2008, it was the first company to directly hire, train and manage its own nurses. Although a number of other providers have since copied PCM’s model of direct relationships with mobile research nurses, no one has been perfecting this model longer than PCM Trials.

The company only deploys RNs who typically come with experience in emergency medicine or have worked in ICUs and have demonstrated an ability to independently multitask and solve unexpected problems on their own. Since the company has been building its database of experienced nurses for more than 14 years, it is able to staff up quickly for trials of varying size. With all training conducted under the direction of sponsors by PCM Trials, sponsors have the confidence in knowing that the nurses handling their data have been consistently trained in everything from GCP to specific protocols for a given trial.

PCM Trials additionally maintains a central depot where it stocks commonly used supplies and employs a team of logistics specialists who stand ready to customize equipment, supplies and kits as prescribed by the protocol. This type of supply chain expertise and study-specific experience honed over 14 years of logistics management enables the company to respond quickly to changing protocols and maintain consistency of care and data integrity.

To learn how a fully decentralized approach using mobile research nurses could help advance your next trial, contact PCM Trials at [email protected] or call 303‐253‐7470.