Leveraging DCT technology, services, and site models for long-term follow-up oncology studies
The U.S. Department of Health and Human Services identified the major obstacles to conducting clinical trials in the US as being “high financial cost, the lengthy time frames, difficulties in recruitment and retention of participants, insufficiencies in the clinical research workforce, drug sponsor-imposed barriers, regulatory and administrative barriers, the disconnect between clinical research and medical care, and barriers related to the globalization of clinical research.” Each one of these challenges can be overcome through the decentralization of clinical trials.
These challenges are particularly relevant at oncology research centers with an increasing number of innovative studies on long-term immunotherapies. Between the cost of running the initial phases of an oncology study, the challenges of maintaining limited capacity, sites struggling to retain adequate staffing levels, managing patient burden, and ensuring proper adherence to regulatory requirements, running these oncology trials is no small task.
Since many of the life-long effects of new oncology treatments are unknown, the majority of oncology trials are required by regulatory bodies to include long-term follow-up analyses on patients to ensure safety and effectiveness, determine long-term side effects, and more. Although these types of studies are inarguably important, conducting them can be challenging for oncology sponsors.
One of the most significant boundaries for long-term follow-up (LTFU) studies in oncology is the need for a convenient method of patient participation like decentralized study sites. When receiving initial oncology treatments and immunotherapies, some patients will travel across the country if necessary in order to participate. However, for these LTFU studies, that amount of travel isn’t necessary. Patients don’t want the burden of having to travel to physical sites for the next several years after treatment in order to participate in a follow-up trial to assess their well-being. In fact, running a long-term follow-up study with an inconvenient physical site that requires patient travel to participate will likely lead to a significant drop in patient retention and a lack of data collection.
As a result, the clinical research industry has learned that the proper eClinical platforms and virtual sites can be leveraged to allow long-term follow-up patients to participate remotely. In cases where in-person visits are necessary, DCT vendors can partner with local oncology clinics and other more convenient healthcare centers where patients prefer to visit to make clinical research possible at these sites. In order to offer these burden-alleviating options, sponsors need to leverage proper DCT components.
A new report put forth by the American Cancer Society states that “patients report increased likelihood to enroll in decentralized clinical trials.” The benefits of DCTs include better engagement, faster recruitment, the ability to attract a more diverse cohort, and higher retention because travel-related burdens are eliminated.
How DCTs benefit long-term follow-up oncology trials:
DCTs can help ensure a seamless transition from one trial modality to another by using remote capabilities to augment academic site-based research. For example, a study involving advanced cancer cell therapy may start at a hospital or major research center and initially require careful oversight by a physician. Patients in the study may be tracked closely for a short time after the treatment phase of the trial and then be transitioned to less intense remote monitoring over a longer period, which can be completed virtually using DCT tools.
DCT eClinical platforms and technology-driven services are ideal for conducting follow-up functions, required under the trial protocol. Patients can complete all study activities, such as filling out quality-of-life questionnaires, from home using patient engagement technology like ePRO workflows with automated reminders. If biometric data collection is needed, a mobile phlebotomist or nurse can be deployed to patients' homes to collect clinical data such as saliva and blood samples, vitals, etc. These types of activities don’t have to be performed at a major research center by clinicians with advanced skill sets to meet compliance requirements.
By using a DCT model to gather follow-up data, oncology sponsors can focus their resources and expertise on new opportunities for the most cutting-edge oncology treatments. This opens additional modalities for clinical trials beyond the traditional site-based model and allows academic centers to expand their capacity to do innovative research while using clinical resources most efficiently.