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Decentralized Clinical Trials Challenges and Obstacles

Contributors: Laurie Stone

As businesses scrambled to move operations into the virtual office at the onset of the global COVID-19 pandemic, life sciences businesses conducting clinical trials found themselves rushing to adopt a decentralized clinical trial (DCT) model in order to both maintain patient safety and keep R&D and drug discovery initiatives moving forward. While this transition was made in haste, many leaders are recognizing the growing list of benefits businesses can realize with a DCT model. From improved retention to enhanced data sets, the range of benefits has leaders weighing the decentralized clinical trial challenges with a new mindset. In a November 2020 survey, 76% of industry respondents reported at least some decentralized clinical trials taking place. With the tipping point towards DCT sweeping the industry, it’s critical that business leaders have a full understanding of the challenges that come with a decentralized clinical trial model. Below, we’ve outlined 10 of the key decentralized clinical trial challenges life sciences businesses can expect.

Decentralized Clinical Trial Challenge #1:

Limited Availability of Cloud Platforms
  • There are currently limited options for cloud-based platforms to help sponsors manage decentralized clinical trials and collect and manage trial data.
  • Of the options available, sponsors are limited in their ability to select, implement, or integrate the system on their own, requiring considerable time from a technology partner or the platform’s vendor.

Decentralized Clinical Trial Challenge #2:

Lack of Configurable Platforms on the Market
  • The burden of data management and the required analysis is becoming a more urgent issue due to the volume of patient data that comes with data streaming from remote devices and patient apps. Organizations need a configurable and/or single platform where the data can be collected, harmonized, and analyzed quickly and efficiently.
  • Device provisioning services from existing vendors bring with them myriad potential complications and associated costs.
  • Increased complexity in sensor data collection and aggregation can lead to dependencies on third parties, which potentially increases costs and introduces another variable into the process.

Decentralized Clinical Trial Challenge #3:

Integration with Other Clinical Systems is Currently Cumbersome
  • Most of the leading platforms are standalone and require substantial effort to integrate with other clinical systems like Electronic Data Capture (EDC) systems, data repositories, analytics and reporting tools, and more.
  • As the market is still evolving, there is also a lack of preconfigured integrations with wearables or other remote monitoring devices across various therapeutic areas.

Decentralized Clinical Trial Challenge #4:

More Complex Studies Can Lead to Longer Startup Times
  • Studies with medium to high complexity needing more than one platform (eCOA) may experience prolonged migrations, translations, IRB approval and device provisioning.
  • Can increase the cost.

Decentralized Clinical Trial Challenge #5:

Translation Dependencies Create Greater Complexity
  • Translation can add additional dependency on specialist translation vendors.
  • Most electronical clinical outcome assessment (eCOA) vendors have dependencies on third-party translation vendors which adds to the complexity of the operating model, particularly in the case of global studies.

Decentralized Clinical Trial Challenge #6:

Enablement and Training Capabilities Are Limited
  • Subject matter expertise is critical at the site/sponsor level in order to train sites and patients, particularly those who may be less adept utilizing the patient-facing technology necessary in a DCT model.
  • This is compounded by the dependency that sponsors have on platform vendors to serve as the training SMEs – which can limit the availability of SMEs for the various sites and sponsors.
  • Vendors are also struggling themselves with a high turnover rate, further limited availability of training and enablement resources.

Decentralized Clinical Trial Challenge #7:

Current Vendors Have Varying Levels of Sophistication and Quality
  • The market for decentralized clinical trial technologies, services, and capabilities is young and the quality of services vary wildly. Sponsors have to be prepared for a certain level of direct vendor oversight and interaction to ensure success.
  • Vendor data quality represents a potential risk and sponsors have limited ability to control or close the gaps in quality with respect to vendor data quality.
  • Logistics are incredibly complex in a DCT model and many vendors (e.g., FedEx, UPS, etc.) may not have a fully understanding of what is required for turnaround times.

Decentralized Clinical Trial Challenge #8:

Paper-Based Processes Complicate Operations
  • Efforts to digitalize and move resources, processes, and technologies to the cloud have had varying degrees of success in the industry both across companies and within them.
  • Paper-based processes at sponsors, vendors, or sites create further complications and necessitate a degree of manual effort.

Decentralized Clinical Trial Challenge #9:

Current Market Capabilities May Require Multiple Vendors
  • Some studies may have the need for engaging multiple vendors to address the complexity, volume, therapeutic area, and/or other study characteristics that may warrant capabilities outside of a singular platform.
  • Introducing multiple vendors into operating model creates complications with respect to things like home health laboratory supplies and testing, electronic diaries, electronic informed consent, etc.

Decentralized Clinical Trial Challenge #10:

Remote Patients Will Require a Different Approach to Patient Engagement
  • The remote nature of DCTs can make it difficult to maintain the person-to-person connections that drive patient engagement, i.e., physician/patient relationship.
  • Augmented reality (AR) and virtual reality (VR) technology can be considered for more complex trials such as in oncology.

 Adopting a DCT model isn’t a simple undertaking but it’s one that life sciences leaders have no choice but to consider moving forward as it has the potential to create a significant competitive advantage. Decentralized clinical trials are not only a patient-centric approach to drug development, they enable risk mitigation against future disruptions like the COVID-19 pandemic. Whether a business is considering a fully decentralized clinical trial model or a hybrid composition, the challenges above must be adequately addressed early in the process to ensure a sustainable DCT transition.

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Coauthor and contributions by Nikki Trammell

Tags: Clinical Operations