For patients with rare, incurable, or life-threatening diseases, clinical trials can offer new hope. Cancer patients, specifically, are often highly motivated to participate in research, particularly when they have an advanced or treatment-resistant form of cancer.
However, clinical trials in the oncology space aren’t reaching many cancer patients who could most benefit. Structural and clinical barriers make trial participation unachievable for more than three quarters of cancer patients, according to research published in the Journal of the National Cancer Institute. In fact, researchers noted that trials were completely unavailable for patients at their cancer centers 55.6% of the time.
Decentralized clinical trials (DCTs), either fully virtual or hybrid clinical trials that include both remote and on-site components, can play a key role in increasing access and, ultimately, enhancing patient care within oncology clinical trials.
Full decentralization is not suitable for every oncology clinical trial. Typical constraints to decentralization include logistical challenges such as:
Despite these constraints, adopting DCT components through hybrid study models can streamline many processes within oncology clinical trials, improving quality of life for participants.
Incorporating DCT elements into oncology clinical trials:
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Extending the survivability of an illness is a key goal in the development of new medications, medical devices, and treatment protocols. Increasing overall quality of care is an equally worthwhile objective. Incorporating DCT elements facilitates both goals.
Patients are often willing to participate in clinical studies that their doctors recommend. But, physicians outside of major medical centers are frequently unaware of trials that colleagues in their field are conducting. Even when made aware, clinicians face the added complexity of finding specific trials that fit the needs of their patients.
With DCTs, however, physicians have access to a larger scope of clinical trials for oncology to recommend to patients who may qualify. Rural physicians may be able to support ongoing research by referring patients to trials without overburdening a small community hospital that can’t support a large, centralized trial.
A major benefit of DCTs is the ability to reach underserved and marginalized communities in ways that traditional trials cannot. In many cases, this means increasing access to patients who lack reliable transportation to trial appointments.
Many at-risk patients also live rurally, requiring even those who have reliable transportation to travel multiple hours to a major medical facility. Decentralization provides these patients with access to new care options without them needing to leave their homes as frequently.
Bringing trials directly to patients also solves another barrier to clinical trial access: Cancer treatments can take a physical and emotional toll, and patients may not be able to travel for more appointments than strictly necessary. By enabling them to participate in studies virtually, DCTs allow patients to stay more comfortable at home whenever possible.
Most oncology trials will continue to require visits to clinics. However, certain appointments are more administrative than interventional and don't require the face-to-face involvement of a clinician. DCT components can reduce the need for this type of in-person visit, which can subsequently and significantly decrease participant burden.
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One of the biggest hurdles to accurate data collection is patients’ hesitation to report symptoms and possible adverse effects. Patients may be reluctant to contact their principal investigator or trial support staff if they develop a new or unexpected side effect as the weekend approaches. These symptoms have a way of escalating over the weekend—often requiring patients to seek unplanned, emergency medical treatment if they can’t reach their physician.
Weekly Friday check-ins with a DCT team can mitigate these issues around symptom reporting. Regular communication with the study team encourages patients to flag what they might otherwise view as minor changes—and ultimately reduces the weekend burden on healthcare resources.
Real-time reporting and communication are major benefits of decentralized clinical trials in oncology. Let’s say a patient is wondering whether dry mouth is a worrisome side effect of a trial medication. In a traditional, site-based study, they might brush off this symptom because of the hassle of scheduling another appointment or the fear of bothering their physician. But, in a DCT setting, they can use a convenient in-app messaging tool to ask the trial team if this symptom is significant.
With a trial team at their disposal, patients are likely to share seemingly unimportant information that is, in fact, invaluable to trial teams and sponsors. This data helps teams make better evidence-based decisions around the impact of a treatment on a patient’s quality of life. And, after the trial concludes, better data empowers clinicians to compare treatment options more effectively.
In lieu of capturing a brief snapshot of a patient’s health during a clinic visit, DCT platforms allow sponsors to gain a more continuous or longitudinal view of how that patient's health may be trending.
For example, a patient may experience nausea and vomiting as a side effect of a trial medicine. If the patient only reports those symptoms at one monthly checkup, clinicians may think it is a one-time incident. However, if the patient logs symptoms daily or weekly using electronic patient-reported outcome (ePRO) tools, team members can see that the stomach upset is a more frequent occurrence. Not only will the study team find out more rapidly, but they can also make better care decisions based on this more robust information.
DCTs hold particular promise in validating treatment options for common types of cancer, including breast, colon, lung, and prostate cancer, which have larger participant pools and quicker recruitment times. Studies without site-based treatment also lend themselves well to DCTs. For instance, validating oral cancer drugs with no need for infusions provides ideal conditions for decentralization.
While full virtualization may not be feasible in many oncology clinical trials, study teams can adopt a modular approach (for instance, incorporating online recruitment or digital questionnaires). These options allow sponsors to digitize certain stages of the trial, based on the study’s protocols, endpoints, and outcomes—further expanding access to life-changing treatment.
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ObvioHealth is a new breed of Virtual Research Organization (VRO) leading the long overdue digitization and virtualization of health research to accelerate the development of innovative drugs and devices across the globe. Recently listed #390 on the list of Inc 5000's fastest growing companies, we are pioneering new ways to collect data, recruit and engage patients and identify novel outcomes that help to bring life-improving health solutions to market faster. Our patient-centric mobile application and platform enables subjects to use their smartphones as well as wearables and other remote monitoring devices to participate remote in clinical trials from the comfort of their homes while delivering more cost efficient and accurate data to sponsors.
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