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The future is now for decentralized clinical trials

July 12, 2021 - 349 views

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The future is now for decentralized clinical trials

Here are six ways decentralized clinical trials will become more mainstream in the post-COVID landscape.

In 2020, social distancing and other COVID-19 mitigation measures led life sciences organizations to pursue new approaches to digital patient engagement. With the prospect of clinical trials grinding to a halt and putting participants’ health at risk, it became critical to take a new look at alternatives to the traditional clinical trials approach.

So began the age of decentralized clinical trials and the emerging models that enable research participation outside of traditional clinical site environments for both trial participants and researchers. With increased demand for supporting decentralized clinical trials, technology is evolving to meet the needs of life sciences researchers and patients. More sensors, more data, more engaging ways of interacting with trial participants — it’s all part of the future of clinical trials.

The way forward for clinical trials

Here are six ways we see technology better serving researchers and patients in 2021 and beyond.

  1. More access to patient data through devices. Collecting timely data from patients if they aren’t reporting to a clinical trial site can feel like an insurmountable challenge. Our inboxes are full, our lives are busy, and remembering to submit or report health metrics feels like one more easily forgotten task for patients.

    Enter consumer devices, such as fitness trackers and smart watches, as well as clinical devices like ECGs and pulse oximeters. Through passive data collection, these devices can raise a red flag indicating a need for follow-up or present an additional data point in research findings.

    We’re currently working with a client to explore the use of a non-invasive sensor to periodically measure levels of potassium, which may serve as a risk indicator for patients on an oncology therapy. Additionally, features like push notifications can serve as a reminder to perform a protocol-related task, present progress or check in with the research team.

  2. Better, safer patient experiences. Clinical trial participants increasingly expect a consumer-like experience. They need easier, faster ways to schedule appointments, onboard and view critical information about their medication, therapy or medical device.

    Wearable devices, companion apps and modern service design can reduce friction and elevate the human experience while also improving safety. With an elegantly connected solution, researchers can determine quickly when adverse events occur, pinpoint a specific population if needed, and adjust the study trajectory to improve outcomes for all patients.

    On a recent client project, we helped develop a digital risk assessment for patients starting a new therapy. Using the tool, clinicians can develop a personalized patient starter pack, based on any pre-existing conditions, preferences and behaviors that are identified.

    For example, since proper hydration is critical for safe use of the therapy, a smart water bottle that tracks water intake is now included in the starter kit for patients whose behavioral data reveals low hydration habits. In turn, care providers are notified when patients are not drinking enough water to support safe use of the product. This kind of personalized approach can impact engagement and patient safety.

  3. New approaches to big datasets. As more clinically validated devices become available, so does the potential for more data collection. Instead of collecting information every few weeks, researchers will be able to measure a wide range of data points as often as they choose. While this will reduce the administrative burden (no more scheduling site visits to collect data that can be gathered remotely), the increased data volume and velocity will pose new challenges. New processes and approaches to big data will help turn a firehose of information into results that lead to more efficient operational analysis and improved clinical insights.

    Cloud-native platforms such as Philips HealthSuite provide a foundational system of record with which analytical models and dashboards can be deployed to visualize study performance. These platforms can be integrated with systems like our Shared Investigator Platform to share insights among study teams.

  4. Better patient technical support. Technology doesn’t always work how we expect; common household tech problems such as dropped Bluetooth connectivity could also have important consequences when a study or therapy relies on them. Depending on the patient population, there might be a significant learning curve for self-troubleshooting such issues, let alone getting up to speed on a new device.

    Researchers will need to develop new channels for supporting patients’ technology needs, including knowledge bases and AI chatbots, to keep patients — with their varied degrees of digital literacy — engaged, ultimately preventing drop-off.

  5. The use of video and immersive content for patient education. As patients learn the ins and outs of new devices necessary for study participation and familiarize themselves with their disease state and the study approach, researchers can use technology to communicate with patients in new ways. Video content can show patients how a drug or device is designed to work, so they can better visualize the potential health implications.

    Immersive content, such as interactive infographics and augmented reality solutions, can also help patients learn about the science behind a trial and what they need to know to participate. A cardboard box might have a QR code that launches a website displaying how to unbox the contents safely, or patients may be able to hold up their phones and have unboxing instructions overlaid directly on top of their phone’s camera feed.

    In one recent use case, a life sciences company developed an interactive infographic, using a 200-page protocol document as source material, to accelerate training for investigators. The results from the training program were so successful that it was later converted to a patient education tool used during onboarding.

  6. Connections through new community partnerships. A benefit of decentralized clinical trials is the ability to participate anywhere, regardless of proximity to a clinical trial site. However, some interventions, labs or other form of data collection may be required in person.

    Connected systems and new partnerships with community providers will allow researchers to create “hot sites,” such as within a retail pharmacy, allowing patients to go to a nearby facility equipped to support their requirements for participation. Reducing the burden on patients to drive hours to a trial site improves the odds that they’ll stay in the study and increases the opportunity to diversify study populations.

Although taking some portions or all of a clinical trial virtual might seem like a less personal approach to research, leveraging digital technology to engage with patients can help form an equally deep connection. With the possibility of new sensors and data collection methods, modes of patient communication, and community partnerships, these technology advances will serve as the foundation for expanding implementation of decentralized clinical trials in 2021 and well into the future.

Bryan Hill

Bryan Hill is Chief Technology Officer in Cognizant’s Life Sciences organization, responsible for digital solutions and...

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