The U.S. Food & Drug Administration (FDA) recently issued draft guidelines for the use of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices, aiming to make it easier for patients to access experimental therapies.
Citing recent advances in digital health technology, and the impact of the COVID-19 pandemic, the FDA said it expects DCTs to lead the way and “increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges … resulting in more treatment options and improved patient outcomes.”
The advantages of decentralized technology innovations and clinical data management solutions reach far beyond just clinical trials. They can facilitate a smooth shift from established treatments to novel care processes that have not yet become standard in care or therapy management systems. These emerging methods are fostering fresh conversations among Research & Development, Clinical, Digital Strategy, Real-World Evidence, and Medical Affairs departments, as they develop innovative launch and evidence strategies within a unified framework.
New models for decentralized care management
Typically, technologies such as the REDCap Cloud platform, which allow for the secure collection, aggregation, storage, analysis, and access to healthcare data, are used by researchers to facilitate enrollment and participation in clinical trials, and to make that process and data available to other researchers at different sites, for different studies.
The same features that enable the development of the research pathway with secure, private decentralized workflow & data can also be used as a point of care decision support operating system designed to automate multi stakeholder workflows like virtual diagnosis boards, nurse navigator programs, and active quality improvement initiatives, especially for a newly emerging complex precision therapy.
The platform approach can be configured to extend into pre-screening activities where the usual baseline patient data – age, gender, existing diagnoses, lines of therapy, etc. – can be combined to each specific new diagnostic & treatment pathway to recommend appropriate “next best action” including diagnostic guidelines that have recently been highlighted as impediments to precision medicine.
For example, let’s say that a pharmaceutical company has a second-line cancer treatment for patients whose first-line treatment failed, but is having trouble identifying candidates for the drug & guiding teams on what to do next. Patients who could be eligible for the second-line treatment are identified by genetic test and CT scan; the intake platform can be used to flag patients for whom the first-line drug was not effective, routing them for genetic testing and CT scanning to determine whether they’re a good candidate for the second-line treatment, then initiating any benefit verification or prior authorization that might be needed.
The platform could also be used to connect geographically disparate stakeholders during the pre-screening process. Say, for example, that the foremost expert in evaluating candidates for that second-line cancer treatment lives in another country. The platform could assemble all the relevant data for that expert, who can then review the case and confirm whether the patient is likely to benefit from the treatment.
Powerful tools for patient engagement and assistance
In an increasingly specialized and personalized healthcare environment, the same powerful tools that digital platforms such as REDCap Cloud offer for keeping patients engaged and treatment-compliant during clinical trials can be used to assist them along their treatment path.
The platform provides patients with a single point of access to remotely engage with caregivers via a web browser or mobile device, allowing them to build ongoing relationships regardless of their relative locations. These tools also help develop a broader view of the patient experience, by balancing subjective patient feedback with continuous, objective device data. And the eRecruitment and eScreening tools used for clinical studies can also be used in routine medical care, accelerating timelines by reaching a wider range of patients.
Measuring the success of decentralized platform configurations
Delivering technology to support decentralized clinical trials and care processes that are user-friendly, compliant to local regulations, and secure is just the first step. For clinical research sites and health systems that are asking for new skill sets from their staff, upfront training is imperative. A return on investment to justify the overall spend is essential as well. Key metrics, including accelerated patient recruitment, dropout rates, cost-effectiveness, development timelines, staff retention, and overall job satisfaction, will play a vital role in facilitating the widespread adoption of patient-facing technology throughout clinical research and patient care.
Visit our patient engagement page to learn more about REDCap Cloud’s decentralized clinical trial solutions.
