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Managing the Proliferation of Data From Decentralized Trials: A Successful Path Forward

As the industry focuses on creating a more holistic, inclusive experience, these three focus areas can help bridge the gap between patient, site, and clinical research administrators and help to modernize the clinical trial experience for all.

The continued maturation of decentralized clinical trials (DCTs) has given researchers the ability to securely collect real-world data on patients as they go about their daily routines. This broader access provides us with new, more accurate ways to measure outcomes. Not only are we collecting more (and better) direct-from-patient reporting, but clinical data is coming from an ever-expanding range of sources, such as sites, labs, devices, and electronic health records (EHRs).

However, the problem of data consolidation and siloed technology suites has manifested itself exponentially with the industry’s adoption of direct-from-patient data and disparate data sets.

For successful DCTs, hybrid, or even remote trials to successfully operationalize at scale and meet sponsor expectations, it is paramount for organizations to be able to streamline complex data sets into a single and actionable source of truth. How we achieve this in the current eClinical environment is predicated on three key areas of focus for researchers who are looking to answer this question.

Use modern tools and infrastructure

Because of an existing comfort level, many clinical trials still use legacy tools that don’t take full advantage of the opportunities direct-from-patient data brings to studies and clinical outcomes. To effectively manage this real-world data collection, researchers need to select a modern platform that can collect the data, analyze it, and provide insights that can help increase the speed and efficiency of the trial. For example, many DCT tools – including wearables and remote tracking tools – were adopted at scale during the Covid-19 pandemic.

Sponsors and contract research organizations (CROs) for the most part recognized the value of these new approaches. The use of these novel technologies associated with decentralized trial models provide the most promise of impacting the time and cost of bringing life-saving therapies to market. However, eClinical providers should equally be focused on developing systems that amalgamate the use of these technologies and methods into ecosystems that provide a holistic 360-degree view of the patient, sites performance, and overall view into the study. Digital technologies should be seen and used as additive to traditional clinical models and their supporting technology.

In clinical trials, and when used correctly, direct patient data, the multi-modality bits and pieces of information collected allow for reduced operational and patient barriers, resulting in a much faster, more holistic study at both the micro and macro levels. By example, cloud platforms that can open bi-directional communication channels and data transfers for patients, doctors, and trial administrators alike can provide actionable insights at the patient, site, and study levels like never before.

Provide adequate training for staff and patients

We’ve established that digital tools used in decentralized trials, such as remote enrollment tools and data capture methodologies, help create a more flexible clinical trial model, lowering the barrier for entry for both patients and researchers alike. The result is that doctors and trial administrators get a 360-degree view and can analyze all the data captured and, if there’s a problem, they can take action more quickly and respond to the patient directly through a mobile device such as a smartphone.

However, for these digital tools to unlock their true value it is important to ensure all the stakeholders are aligned on roles and responsibilities and have the proper training. This includes the clinical trial platform and digital tools, such as wearable devices. The site needs to know how to conduct proper assessments with and through these technologies and how they augment the trial workflow. On the patient side, often patients and caregivers (who must share the data) are not initially comfortable with using various digital technologies so it is imperative they are provided adequate training to ensure their data is being collected and shared properly.

Identify how technology can support patient engagement 

Patient adherence and retention is paramount to the success of any trial. With better and more efficient real-time communication and feedback, researchers can enable flexibility and efficiency, ultimately making it easier for patients to stay on track and in the study.

In supporting direct patient engagement – through text notifications, alarms, telehealth visits, patient-reported outcomes (PROs), email, or chat check-ins – technology enhances the patient experience. Nevertheless, researchers need to consider how the technology impacts studies from both an operational and outcome standpoint.

We know from past studies that the ability to see patient symptoms on a more frequent basis allows algorithms to be set, enabling professionals to take action both in the trial and in the long term, improving patient outcomes. Think about the caregiver population. A caregiver and their patient may not know they are experiencing an adverse reaction, but proper training enables them to provide real-time or near real-time insight and input, which is more accurate and less affected by recall bias (which is when a patient cannot accurately remember a past event or does not report it). As a result, researchers become aware of potential issues sooner and can take action quickly.

Together, these three areas outline a clear path forward for researchers to consider as they examine how to successfully transition or incorporate a DCT model into their research designs. As the industry focuses on creating a more holistic, inclusive experience, these focus areas can help bridge the gap between patient, site, and clinical research administrators and help to modernize the clinical trial experience for all.

As Oracle’s Executive Director Digital Trials Strategy, David Blackman has responsibility for aligning digital strategies and innovations with Oracle’s developing business needs. Within his role in Oracle’s Health Sciences Global Businesses Unit, David is responsible for creating and developing differentiating technology and business capabilities through development, partnerships and acquisitions that enhance clinical trial research and accelerate bringing drugs to market for our clients. Before joining Oracle in 2021, he served in the Corporate Development and Strategy group at PPD where he had responsibility for PPDs business innovation, leading and incubated cutting-edge business solutions resulting in the investment, development, integration and commercialization of digital and remote clinical trials capabilities.

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