Decentralized trials in oncology call for special attention

Oncology clinical trials took a hit when COVID-19 landed in the research industry, but decentralized trial technology (DCT) helped fuel a recovery. The National Cancer Institute (NCI) reports that their funded studies saw a significant drop at the onset of the pandemic but, with the help of telemedicine and other DCT tools, they rebounded to 80% of pre-pandemic levels. pandemic.

Temitope Keyes, Executive Director of Business Development for Encapsia Data Management Solution at CMED Group, spoke with Outsourcing-Pharma about some of the challenges unique to cancer-focused DCTs and the technologies that can help overcome some of these. particular barriers.

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

TK: The innovation we’ve seen in genetics, biochemistry and translational medicine, along with the advent of precision therapeutics in oncology, make these clinical trials more complex than ever. This presents new challenges for the industry, including the need to manage growing volumes, types and sources of data, as well as the ability to combine and examine them effectively 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 identifying and developing biomarker endpoints, for example, the logistics of managing patient samples and the immediacy of lab reporting require a level of data integration that not found in simpler therapeutic areas. Trial teams and provider partners must fully understand the study protocol, be able to identify the right patients and current treatment practices, and engage KOL sites so that realistic patient site and enrollment plans patients are developed.

Sponsors should identify sites with the experience, resources (eg -70°C freezer) and availability, as well as the patients needed. Oncology trials are typically subject to protracted regulatory reviews, particularly for genetically modified or cell-derived products.

However, the hardest part, especially in these complex indication areas, is negotiating and managing the many disparate data sources, such as imaging, biomarkers, drug supply/randomization and ePRO /eCOA to ensure that all test data (regardless of 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 oncology therapy benefit patients?

TK: The first benefit is that DCTs can make trials more attractive to patients and encourage their continued participation. For patients away from a major research hospital, they can now take part in trials that give them access to the latest treatments. Although remote data collection was initially considered impractical for oncology trials, due to complex assessments that would routinely have to be performed on-site, the past two years have proven otherwise.

DCTs can also expand a sponsor’s reach in terms of registration, allowing for greater representation of diverse populations by eliminating cumbersome in-person visits. This improves the quality of the clinical data collected, facilitates the patient journey and opens up the possibility of wider geographical participation.

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

Temitope Keyes, Executive Director of Business Development for Encapsia, CMED Group

TK: Sponsors need to adopt a strategy of “bringing the technology to the data.” With many oncology treatments requiring an 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 variations with the direct delivery to the patient.

Rather than waiting for data to reach relevant information systems, sponsors should aim for third-party data integration via API and real-time capture of source data (e-Source) with checks and logic point-of-entry editing tools. checks. When choosing DCT technology, the goal should be to remove complexity, streamline processes, utilize adaptable features, and reap the benefits of immediate visibility into test data.

This involves reducing the number of systems and replacing legacy systems with a platform flexible enough to support data ingested in multiple forms from various sources. Flexibility is key, as no two trials are the same and it is nearly impossible to schedule each permutation.

Sites are currently overloaded 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 make sure the technology is easy for patients to use.

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

OSP: So please talk about some of the technology solutions that are helping cancer sites run more efficiently and accurately.

TK: One aspect of oncology trials that we need to consider is the importance of site-patient relationships. Using multimodal data capture, such as a home visit eSource application, can allow sites to access their patients.

Another area that can benefit is the long-term follow-up of patients. Patients can be followed for decades after participating in an oncology trial to monitor disease progression and survival status. Currently, this type of follow-up is done through regular on-site visits and phone calls. This requires significant patient commitment and can be a burden on sites.

Investing in technology that can enable DCTs means that patient monitoring or diary data can be viewed in real time. Patients can be called back to complete patient-reported results, dose escalation decisions can be made, and wearable devices can record data such as vital signs. Reducing 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 the opportunity to improve their efficiency, free themselves from paper and reduce costs.

OSP: How can technology like Encapsia help things work?

TK: One of the issues right now is that although the technology used in clinical trials has advanced, sponsors are still trying to use 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 medium-sized biotech company to aggregate various datasets in Excel, create complex pivot tables, or even dig up the bit of SAS that ‘he knows to generate reports for an interim analysis. , regulatory submissions, effects assessment committees and investors.

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

In oncology studies, for example, where the assessment of tolerance and toxicity in patients can be critical, we believe this is unacceptable in the current era. This data lag is not acceptable in other industries. This is why we have developed a holistic and suitable clinical platform, Encapsia, which has clear advantages, especially for oncology and other complex studies, for example, by providing unique immediacy of data, information and of actions in relation to 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 immediately load various cell and biomarker data as soon as the results are available in the labs, and to display it all in sophisticated and revealing live data overviews, distinguishes Encapsia. These benefits also enable our sponsors to better fulfill their obligations, including helping them support patient safety.

With Encapsia, sites have the choice of modern and intuitive data capture options, including mobile apps, that 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 source and all collected data is aggregated immediately and stored in a repository, with no downtime.

Our holistic platform supports remote monitoring, improving venue efficiency, while sponsors can benefit from enhanced security monitoring 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, saving time and money.

OSP: Is there anything you would like to add?

TK: Scientists, investigators and clinical operations professionals don’t care about the “how” of the technology, they want to know that there are things the technology can improve in their trial. A lost patient sample or one or more missed visits affects protocol endpoints and statistical power. At Encapsia, we know they, and more importantly patients, deserve much better and we have the solution that brings a whole new approach to clinical data operations for oncology trials.

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