Should Your Next Oncology Trial Be Decentralized?

Across a range of therapeutic areas, decentralized clinical trial (DCT) approaches allow high-quality data to be collected at participants’ homes rather than exclusively at sites, making involvement more inclusive and participant-centric.

Today, we see sponsors and CROs conducting DCTs and partially-decentralized “hybrid” studies (combining site-based and decentralized components) for a wide range of therapeutic areas; but in particular, cardiovascular health, mental health, dermatology, neurology, virology, and respiratory disease.

The use of DCT approaches in oncology studies is on the rise but is in the early stages despite the fact that (as of 2019), there have been just over 361,000 oncology studies since 2000, approximately 300,000 more than the second most commonly studied therapeutic area (cardiovascular diseases). This may be attributed to the limited guidance that currently exists on how the spectrum of DCT approaches can improve oncology trials.

Customers often ask us whether DCT approaches are right for oncology studies, and a 2020 survey of Clinical Trials Europe participants noted that oncology was under-represented in its use of DCTs relative to other areas. Because oncology studies often require infusion and/or complex in-clinic therapies, customers often conclude that decentralized approaches are not appropriate. However, DCTs involve much more than just administrating medication remotely and can support all other aspects of an oncology study. Facets of DCTs can be implemented in oncology studies to collect symptom and other data more frequently while minimizing necessary in-person visits via a “hybrid” decentralized approach. In THREAD’s experience, hybrid study approaches allow for a more people-centric approach to oncology trials. For example, participants can complete patient-reported outcomes in private through simple, secure digital tools that work seamlessly on their own devices. They can also complete these assessment pre and post their in-clinic medication administration. This reduces stress by lowering travel burden, limiting the amount of time/effort required by the participant at the visit and by streamlining data-gathering activities around infusion-focused visits.

The Purpose of Decentralized Clinical Trial Approaches

DCTs exist to accomplish three (3) key objectives:

• To make clinical trials more efficient
• To allow for data collection outside of clinical trial sites
• To make clinical trials more accessible and inclusive for participants. With
  less travel, more patients can sign up for clinical trials. Additionally, DCT models enable more sites that are closer
  to patients to participate in clinical research.

A recent global research study by the Center for Information and Study on Clinical Research Participation (CISCRP) reported that 60% of participants felt that “distance to the clinical site” was the primary barrier to their participation in clinical research. For participants in oncology studies, the ability to collect data remotely between necessary infusion visits helps to reduce travel burden and can make study participation more feasible for those living further away from clinical sites.

Using DCT approaches to expand recruitment can also result in cohorts that are more diverse, inclusive, and more representative of the real world. Having participant groups that include multiple races, ethnicities, genders, work schedules, and other characteristics helps to paint a more complete picture of the efficacy and safety of new oncology therapies.

DCTs introduce new efficiencies and reduce opportunities for error. For example, because DCT approaches collect data directly from the source (participant, clinician, observer, etc.), there is no need for a costly Source Data Verification process. Another example would be unscheduled visits, which are commonplace in oncology studies and can add a great deal of cost. Many reasons for unscheduled site visits can be addressed through telehealth visits, which are more affordable for sponsors and more convenient for participants.

• Data from wearable sensors, such as a smart watch or mobile
• ECG Data from other electronic outcome reports (e.g. observers)
• Direct to Patient study drug shipping and accountability

It's About People

Improving the clinical research experience for participants can have a significant impact on trials. More active, engaged participants help to make studies more efficient by adhering to timelines and producing more accurate data. Making trials easier and more comfortable for participants opens possibilities for optimized recruitment and higher retention rates. DCTs help by offering methods and technologies that provide guidance, support, and the ability to submit data remotely.

In a traditional, site-based oncology trial, participants arrive at the clinic where they receive their medications. While there, they are also subjected to other lab tests, interviewed by members of the study team, and are asked to perform other data collection activities. All of this can result in lengthy, stressful visits for participants.

DCT approaches help in several ways. Through remote data collection technologies, data from electronic patient-reported outcome (ePRO) and/or observer-reported outcome (ObsRO) assessments can be submitted throughout the times between clinic visits. Telehealth visits can be utilized to generate clinician-reported outcome (ClinRo) assessments and can be used in tandem with mobile medical devices to generate data remotely. This reduces the need to collect these types of information during the clinical visits, allowing participants to focus on receiving their medication and helping them to get back home sooner.

Making trials easier and more comfortable for participants opens possibilities for optimized recruitment and higher retention rates.

Collecting data during the times between in-person clinic visits provides several important insights beyond symptomatology or potential adverse reactions. Remote data collection can also provide visibility into the participants’ quality of life and daily challenges posed by their lifestyle, living situation and access to support. Data is gathered both subjectively and objectively such as:

• eCOA (electronic clinical outcome assessments)
• Participant or caregiver surveys (e.g. eDiary)
• Medical devices (e.g. spirometers, mobile ECG, blood pressure cuffs, etc.)
• Wearables and sensors (e.g. actigraphy devices)
• Image capture (e.g. skin photo imaging)
• Real world data integrations (e.g. medical record data)
• Visit availability and scheduling

Data from these tools provides study teams with a comprehensive picture of participant status. THREAD tracks changes in activity, movement and symptoms following infusion therapy, but we can also quickly see any unexpected changes in the data that occur days or weeks after a dose. Knowing this information eliminates the need for it to be collected during in-person visits, helps study teams identify adherence challenges, and provides clues to tailored support that would keep them on track.

Participants in oncology studies have many day-to-day challenges. Like everyone, they have jobs, family responsibilities, and outside interests all while living with a challenging medical condition. Add to those the need to submit study data and travel for regular clinical visits. Technologies utilized in DCTs offer participants study-specific resources to access support and guidance from the clinical team.

These can include reaching out to the clinical team with questions or to report concerns, or scheduling telehealth visits, usually all within one (1) comprehensive, omni-channel platform designed around participant ease-of-use.

With the technology available, guidance does not always need to come from the study team. Libraries of content accessible

online or via the smart device application can walk participants through their responsibilities or offer video tutorials to refresh training on data submission processes. DCT approaches can automate a great deal of participant support content while providing easy-to-use and always-available channels for study team outreach that participants can utilize when they have more specific questions or issues.

Many elements of DCTs can be utilized to improve oncology studies. Hybrid decentralized study approaches combine the best facets of traditional and decentralized designs, allowing for more frequent and better data to be collected while simultaneously providing a central experience for participants. Data can be gathered more frequently away from the clinic, and with less room for submission error as information is collected directly from the source. Participants can then enjoy less stressful clinical visits where they can focus on convalescing instead of data collection.

References:

1. Grande, R. (2019, November 26). Most Common Clinical Trials by Therapy Area. Definitive Healthcare. https://blog.definitivehc.com/most-common-clinical-trials bytherapy-area
2. https://pharmaintelligence.informa.com/resources/product-content/sitecore/shell//~/media/informa-shop window/pharma/2020/covid-24-campaign/slides/decentralized clinical-trials-in-2020.pdf
3. https://www.ciscrp.org/ciscrps-2019-perceptions-and-insights-study/
4. Khozin, S., Coravos, A. Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations. Clinical Pharmacology & Therapeutics, April 2019. DOI:10.1002/cpt.1441
5. https://www.pharmavoice.com/digital-edition/june-2021#45