Mapping the Future of Decentralized Clinical Trials
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Decentralized approaches reduce the burden of a clinical trial on the patient, accelerate enrollment, improve retention, broaden the diversity of the patient population and potentially shorten timelines. As with any new process, the challenge lies in the continually evolving landscape. As a result, the lack of established regulatory guidelines can be tricky to navigate.
The paradigm of decentralized approaches is developing and we should expect that the regulatory guidelines will evolve as well. From our broad and varied experience in conducting decentralized studies, we have considerations that are helpful when laying the course for a successful clinical trial.
Design Early Engagement into Your Trial
In the absence of concrete, stringent guidelines to guide your trial design, engage with stakeholders early in the process. This mitigates any unpleasant surprises amid the trial, as well as the risk of wasting valuable time and resources. Including regulatory bodies in the early planning stages through consistent communication is the single best thing you can do to design a protocol that has the context that regulatory bodies need.
How to Keep the Regulatory Bodies Engaged
While it might seem logical to rely on the guidance for decentralized approaches that were utilized during the height of the COVID-19 pandemic, we would caution against this. We expect the guidance to evolve and vary by region, so direct engagement on several points at the outset is imperative. Those affected by the European Medicine Agency (EMA) will be mandated to use a centralized database and portal for clinical trials in January 2022. We’ve outlined the key points below:
We recommend having a clear system for knowledge management. This should include regulatory information and experiential data, so you can reference how certain aspects were accepted and conducted in previous studies, recognizing that the context of the study protocol is pivotal in the interpretation.
Build data systems transparently so that data can cleanly flow from one system to another. Regulators will want to see these data maps, and the data maps demonstrate how we will ensure data integrity even when data are collected from multiple sources. It’s critical to have clear mechanisms to ensure the principal investigator can achieve the necessary oversight.
Monitoring Should be Unambiguous:
Creating a monitoring plan that focuses on the critical data and processes and provides clarity on who is monitoring what data and how, is crucial. We recommend considering how the audit trial functionality within the various systems can be used to support monitoring integrity.
Prepare for Ambiguity:
It is likely that the regulations released won’t be prescriptive given that the context of the protocol is vital in making an assessment. Be extremely clear on how you’re measuring the data, and that it can be reviewed in a way that’s meaningful.
Involve Patients from the Beginning
Taking a decentralized approach often relieves much of the burden on patients participating in the trial. As with regulatory bodies, engaging with patients early in the process will help you better embed them in the design of a truly patient-centric trial. The aim of gaining their perspective is to allow patients the flexibility on how they access their care, whether through mobile research nursing, or on site.
Ensuring a spectrum of patients across representative ages, diversity and socioeconomic factors, is ultimately better for all patients. Accessing them via patient advocacy groups or through multiple specialist companies that have built patient communities, helps you connect to a much more varied patient population.
Partnering With Technology Providers
Technology is the linchpin to DCTs to allow for remote data collection and heightened data integrity. But we often caution against letting technology lead the study. When you are engaging a technology partner, it’s optimal to have a holistic view of their offering and experience.
While a technology partner’s experience is valuable, it doesn’t always guarantee robust intelligence. You need to understand the context in which the intelligence was gathered, and whether it was applied correctly to ensure that the study parameters and the intended use of the data were comparable.
Conducting a global DCT will inevitably lead to additional complexities from region to region. Sponsors should be flexible and adaptable depending on the local regulations. There is also interoperability between policies and regulations, from clinical trial regulations to data privacy regulations, as well as standard medical management guidelines. It is vital to have an awareness of the regulations that can affect any given section and that the most stringent guidelines are applied.
Become a Part of the Evolution
The regulatory environment for DCTs is going to continually evolve as more and more clinical trials adopt this methodology. One of the most impactful ways to efficiently work within this landscape is through early stakeholder engagement. Incorporating stakeholder feedback in the early stages and creating a flow of information will help ensure that you realize the benefits DCTs offer.
We view having the ability to have a truly patient-centric approach as one of the most important benefits a DCT can offer. Higher efficiency, a reduction in study timelines, greater access to a wider and more diverse patient population, as well as high-quality data, are the benefits of DCTs.
To gain full advantage of these benefits, thinking through all aspects of the DCT and engaging with relevant stakeholders early on will help you embed this knowledge into the trial. Transparency with regulators, along with the learnings from previous trials, will help inform future guidelines as DCTs become a more practiced method.
Learn more about Decentralized Solutions from Syneos Health here.