Tech Integration for Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-02-01-2022, Volume 31, Issue 1/2

Six best practices and three key mistakes to avoid in new technology space.

From e-health records (EHR) to digital twins, technology continues to evolve in an increasingly complex landscape that starts with study approval and planning and extends to long-term sample storage. Understanding best practices for tech integration can help partners across the clinical trial workflow, like CROs, sponsors and suppliers, create reliable, patient-centric, and compliant trials that get critical treatments to market faster.

1. Think beyond wearable devices

The scope of technology that supports clinical trials extends across the full clinical trial workflow. As you design the trial, consider the full range of tools. One example is artificial intelligence (AI). This technology is being evaluated to create a digital twin to help predict how a patient would react if they had received a placebo. By eliminating the need for a placebo cohort, AI can lower recruitment requirements, reduce trial length, and increase patient access to the active drug.

Logistics is also an area ripe for smart technology integration. Modern packaging options provide far more than a shipping box for a clinical trial kit. Consider savvier technology, like packages enabled with near-field communications. Equipped with radio frequency identifiers, these packages can communicate with an app that not only tracks the package during shipment, but also provides updates on when the patient opened the package. If the patient must access the kit at specified intervals, this type of data can indicate whether the patient is adhering to protocol schedule.

2. Define and build for reliable data

Clinical trial partners increasingly rely on a menu of technology suites to support their trials, particularly decentralized elements, like remote monitoring or mobile visits.1 Without reliable data collection that’s accurate and repeatable, clinical trials face potential delays that waste time and money.

One aspect of creating an ecosystem for reliable data involves asking up front: what’s the right data set and data detail required for our protocol? While this has always been a core question, technology has added additional considerations. Wearable and other technology can inundate investigators with an ocean of data, especially with devices that offer continuous monitoring. And while all that data can be attractive and relevant, it must still be managed and analyzed. If it’s not essential to the protocol, the data—and the management it requires—adds complexity, time, and costs.

In contrast, it’s also important to ask the question: can any data we collect now be used for future drug development? Reliable storage of not just the physical but the digital sample can help bring future treatments to market without the time and cost associated with new patient enrollment.

Streamlining processes to reduce the rate of data errors also supports reliability. For example, the Clinical Trials Transformation Initiative (CTTI), an association that aims to create a vision for the future of clinical trials, recommends that clinical trials be fully integrated into existing health systems. Doing so would potentially allow a clinical trial to access—with consent—a patient’s EHR and eliminate the need to collect data already in the existing record.2

3. Develop data management for the full workflow

The scope of available technology demands more robust data management systems than ever before. From start-up to closeout, data management must span the lifecycle of the clinical trial.

Data management requires coverage across the full clinical trial workflow—and that includes long-term sample storage, which sometimes isn’t fully considered until the end of the sample’s lifecycle. Long-term sample storage must include considerations around tracking and tracing of samples at the storage unit level globally. In addition to the track-and-trace technologies that support the sample, technology is critical for biorepository temperature monitoring, maintenance, and kick-off, or redundancy systems in any event that could risk sample integrity.

Clear data ownership at every step of the clinical workflow is critical, from patient recruitment to drug supply to sample processing to long-term storage. If there are questions at approval submission, the sponsor will need to have clear guidance regarding ownership of each data piece.

Seamless data flow between all partners is equally important. Each partner now has a responsibility to make the investment in front-end and back-end integration that supports data management across the clinical trials workflow. While there is still work to be done in regard to seamless data integration, CROs, suppliers, and other partners are making strides to drive this transformation.

4. Streamline the patient experience

The evolving technology landscape and the COVID-19 pandemic’s impact on clinical trials has enabled and accelerated decentralization of clinical trials, creating an experience that brings the trial to the patient. However, these advances can present a challenge: patient-facing technology is only as powerful as its usability to patients. Devices and other technology that are hard to understand or inconvenient to use can negatively impact patient experience—and that can take a toll on everything from patient enrollment to data reliability.

One aspect of building a patient-centric experience is ensuring patients are comfortable with the digital tools that they will be required to use for the duration of the trial. Patients may require training to use some wearable health devices, so it’s important to consider how they will access effective training. For example, in addition to collecting data, a clinical trial app installed on the medical wearable can offer instructions, such as videos that guide a patient step-by-step through a particular process.

Another, sometimes overlooked, technology challenge is aligning device choice to regional preferences where the clinical trial is being conducted. Consider a clinical trial that will collect data, like cardiovascular rhythm or body temperature, via a smartwatch device. If you choose a wearable brand that patients in that region are not familiar with, you risk reduced enrollment and lower adherence—even if the technology in the unfamiliar brand mirrors the regionally familiar smartwatch.

Using technology to support patient-centric clinical trials also requires consideration of what’s referred to as the digital divide. Depending on the population, factors like age and educational differences can impact technology use and adoption.3

Despite the challenges, one of the most exciting aspects of the clinical trial technology evolution is that we could soon conduct trials in which the patient will use just one app to manage their full experience, from participation consent to device management to kit receipt to sample packing and shipment instructions. A scenario like that has the potential to not only increase adherence but also further enhance the patient-centric experience.

5. Understand the regulatory framework around technology

Just as regulations for clinical trials, as a whole, have evolved, regulatory frameworks across the globe now increasingly address the use of clinical trial technology. For example, if the study will rely on a consumer device, like a smartwatch, choose a brand that aligns with relevant regulatory standards of that region. A specific wearable device might monitor functions like heart rate but not provide the level of secure data transmission required in the region where the clinical trial is taking place.

The regulatory consideration extends beyond medical wearable devices to the full clinical trial workflow. Consider data and cybersecurity in logistics. In the traditional clinical trial site setting, partners like suppliers and logistics companies didn’t have access to patients’ personal information. Now, a single decentralized clinical trial can require kits to be shipped to thousands of patients’ homes, exposing a patient’s name, address, and perhaps even the type of equipment they receive and trial they participate in. As a result, all clinical trial partners must be ready to navigate GDPR in Europe and HIPAA in the US, as well as other regional data privacy and security regulations.

Conducting trials in emerging regions can require special consideration. In areas like the BRICS block (Brazil, Russia, India, China, and South Africa) and the Middle East, clinical trial regulations have improved in the last several years, helping better harmonize research standards globally. However, like Western countries, they are now challenged with bringing regulatory framework around factors like data and privacy up to speed.

As these nations continue to build and evolve their regulations, it’s critical for CROs, sponsors, and suppliers to work with local experts familiar with that specific region and any evolving standards. Partnering with a local CRO can help ensure proactive and flexible use of the right clinical trial technology to run a smooth trial that stays on track, on budget, and in good regulatory standing.

6. Consider technology when choosing clinical trial partners

Technology cannot be an afterthought when selecting CROs, suppliers, logistics services, and other partners. As you select partners, ask:

  • Do I already have a formal integration with this partner? And if so, are we already transmitting data seamlessly back and forth, or do we need an improvement?
  • Who owns the data at any given stage of the workflow?
  • If the partner’s technology is already integrated with their own suppliers, how quickly can we react if we have an urgent need for equipment in, for
    example, Zimbabwe?
  • If the clinical trial is held in an emerging region, do we have the right level of local expertise to guide technology integration with that specific population? And do we have compliant tech integration for that region at all levels, from patient recruitment to supply chain?
  • Are all my suppliers and partners fully integrated in a way that makes technology—and data—easy, seamless,
    and reliable?

Technology is a powerful tool that helps clinical trial teams get life-changing treatments to market faster, but all partners must work together to create tech integration that’s reliable, patient-centric, and compliant.

Claudia Berrón Senior VP, Clinical Services, Avantor

References

  1. McKinsey & Company. No place like home? Stepping up the decentralization of clinical trials. (Online) Available at: https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials (Accessed 12-20-2021).
  2. Clinical Trials Transformation Initiative. Transforming Trials 2030. (Online) Available at: https://ctti-clinicaltrials.org/who_we_are/strategic-vision/ (Accessed 12-20-2021).
  3. Marquis-Gravel, G. Technology-Enabled Clinical Trials. Circulation. (Online) Available at: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.040798 (Accessed 12-20-2021).