Oncology decentralized trials call for special consideration: Encapsia

Oncological clinical trials took a hit when COVID-19 landed on the research industry, but decentralized trial (DCT) technology has helped fuel a recovery. The National Cancer Institute (NCI) reports their funded studies saw a significant drop at the opening at the pandemic but, with the help of telemedicine and other DCT tools, they’ve bounced back to 80% of pre-pandemic levels​.

Temitope Keyes, executive director of business development at Encapsia, spoke with Outsourcing-Pharma about some of the challenges unique to cancer-focused DCTs, and technologies that can help overcome some of these special obstacles.

OSP: Could you please talk about some of the special considerations when running an oncology trial—what makes it different from a study involving most other conditions?​

TK: The innovation that we’ve seen in genetics, biochemistry, and translational medicine, along with the advent of precision therapeutics in oncology, makes these clinical trials more complex than ever. This presents new challenges to the industry, including the need to manage increasing volumes, types, and sources of data, as well as being able to efficiently combine and review them to make informed decisions.

When it comes to oncology trials, there are a few specific hurdles that come to mind. If we look at the importance of identification and development of biomarker endpoints, for instance, then both the logistics of patient sample management and immediacy of lab reporting require a level of data integration not found in more straightforward therapeutic areas. Trial teams, and vendor partners, need to fully understand the study protocol, be able to identify the right patients and current treatment practices and engage KOL sites so that realistic site and patient enrolment plans are developed.

Sponsors need to identify sites with the experience, resources (e.g. a -70°C freezer), and availability, as well as the patients needed. Oncology trials typically have prolonged regulatory reviews, particularly for genetically modified or cellular-derived products.

What’s most challenging, however, especially in these complex indication areas, is negotiating and managing the many sources of disparate data, such as imaging, biomarker, drug supply/randomization, and ePRO/eCOA to ensure all the trial data (from whatever source) is readily available, aggregated and integrated, and of the highest-quality and veracity, for review and action.

OSP: How does operating a decentralized trial for an oncology therapy benefit patients?​

TK: The first advantage is the fact that DCTs can make trials more appealing to patients and encourage their ongoing participation. For patients not near a major research hospital, they can now participate in trials that give them access to the latest treatments. Although remote data collection was initially thought impractical for oncology trials, due to complex evaluations that would routinely need to be performed onsite, the last two years have proved otherwise. 

DCTs can also broaden the reach of a sponsor in terms of enrollment, allowing for more representation of diverse populations by eliminating cumbersome in-person visits. This improves the quality of clinical data collected, eases the patient journey, and opens up wider geographical participation possible.

OSP: Could you please talk about some of the challenges a DCT involving a cancer drug might present to the site and sponsor?​

TK: Sponsors should adopt a strategy of “bringing the technology to the data.” With many oncology treatments requiring infusion or injection, time is of the essence, and this is where data integration can address the need for just-in-time drug supply or concerns about temperature excursions with direct-to-patient delivery.

Rather than waiting for data to make its way to the relevant information systems, sponsors should aim for third-party data integration via API and real-time capture of source data (e-Source) with robust point-of-entry edit checks and logic checks. When choosing DCT technology, the aim should be to remove complexity, streamline processes, use adaptable functionality, and enjoy the benefits of immediate visibility to trial data.

This involves reducing the number of systems and replacing legacy systems with a platform that is flexible enough to accommodate data ingested in multiple forms from various sources. Flexibility is key, as no two trials are alike, and it is virtually impossible to plan for every permutation.

Sites are currently burdened with having to learn and use multiple systems across studies, so it’s prudent to consider what will work best for them. And, because decentralized trials involve collecting data directly from patients, it’s important to ensure that the technology is easy for patients to use.

The aim should be to use technology with a user interface that mimics those of consumer systems and minimizes the need to access multiple systems. It must be intuitive, interactive, and engaging, with clear navigation that is similar for all users to support collaboration.

OSP: Then, please talk about some of the technological solutions that help oncological sites run more efficiently and accurately.​

TK: One aspect of oncology trials we need to consider is the importance of site relationships with patients. Using multi-modal data capture, like a home visit eSource app, can allow sites to go to their patients.

Another area that can benefit is long-term patient follow-up. Patients can be tracked for decades after participating in an oncology trial to monitor disease progression and survival status. At the moment, this type of follow-up is done by regular site visits and phone calls. This asks for a significant commitment from the patient and can be a burden for sites.

Investing in technology that can enable DCTs means patient monitoring or diary data can be accessed in real-time. Patients can be reminded to complete patient-reported outcomes, dose escalation decisions can be made, and wearables can record data such as vital signs. Reduction in travel costs to sites, maintaining easy contact with physicians, and automated reminders can ensure patient engagement, adherence, and compliance as well as timely data collection.

Finally, sites have an opportunity to improve site efficiency, free themselves of paper, and reduce costs.

OSP: How can a technology like Encapsia help things run smoothly?​

TK: One of the problems experienced currently is that while the technology used in clinical trials has advanced, sponsors are still trying to make use of a patchwork of separate, integrated, and point solutions with poor interoperability. Today, it’s not uncommon for a vice president of clinical operations at a small- or mid-size biotech to aggregate various data sets in Excel, create complex pivot tables, or even dig up the bit of SAS they know to generate reports for interim analysis, regulatory submissions, endpoint adjudication committees, and investors.

A common data view in oncology is the patient profile, but in a trial with fractured, siloed data eCRF, routine blood lab, biomarker, and imaging datasets suffer long lags between collection and analysis or visualization.

In oncology studies, for example, where tolerability and toxicity assessment in patients can be critical, we believe this is unacceptable in today’s age. This data lag is not acceptable in other industries. This is why we’ve developed a holistic, fit-for-purpose clinical platform, Encapsia, that has clear benefits, especially for oncology and other complex studies, for example, providing a unique immediacy of data, insights, and actions compared to traditional systems.

In CAR-T cell studies, where toxicity is a concern, the immediacy of data, including live updating of individual patient profiles, the ability to load various cell and biomarker data immediately as the results become available at the labs, and to display all this in live, sophisticated and revealing data insights, sets Encapsia apart. These benefits also enable our sponsors to better meet their obligations, including by helping them support patient safety.

With Encapsia, sites have a choice of modern, intuitive data capture options, including mobile applications, to suit them – they can use any hybrid approach between EDC, DDC, and HomeVisit. Third-party data (e.g. routine labs, biomarkers, ECG) can be loaded at the source and all data collected are aggregated immediately and stored in one repository, with zero downtime.

Our holistic platform supports remote monitoring, thus improving efficiencies for sites, while the sponsors can benefit from improved safety oversight as well as live insights and analytics where they can see and act on all the data, making better and faster clinical trial decisions. Encapsia also offers more streamlined processes for all clinical trial stakeholders, leading to time and cost savings.

OSP: Is there anything you’d like to add?​

TK: The scientists, investigators, and clinical operations professionals don't care about the ‘how’ of the tech, they want to know that there are things that technology can make better in their trial. A lost patient sample or missed visit(s) affects protocol endpoints and statistical power. We at Encapsia know they, and most importantly patients, deserve much better and we have got the solution that brings a whole new approach to clinical data operations for oncology trials.