Adoption Challenges

Digital/Decentralized clinical trials can significantly change the clinical development business models. Many new and existing market players offer decentralized clinical trial platforms to allow companies to adopt DCT. The notable players are Medable, Science 37, Thread, Medidata, Castor, LabCorp, Iqvia, etc.

However, the shift to Digital Clinical Trials brings its own set of challenges beyond platform adoption. It requires transformation across the spectrum of clinical trials and consideration that each trial is different.

Establish Trust – Sponsors need to build the patient's trust in delivering the care through technology, assuring a better treatment despite no/limited physical interactions with the investigator. Although trust in health using digital technologies has improved a lot post the pandemic, sponsors still need to reassure the participants by showcasing an understanding of the needs of the participants/condition
User education – All patients do not share the same level of technology literacy. Sponsors must put up easy-to-follow training materials and establish a support system to train the patients on various systems, including setup, sample collections, and devices that are part of the trial. It is important to enable them to reach out for technical help easily and overcome their aversion to change
Logistics – Requires extensive planning to have the devices for home monitoring delivered to participants in time, ensure the procedure is followed to collect samples and ship to the facility, and manage order refills, returns, or complaints.
Data Handling – With quality and real-time data flowing in from the participant's systems/devices and integrating across different participant systems, data integrity, privacy, storage, and processing are crucial for success
Cybersecurity and Fault-tolerance – Wearables, sensors, and digital products communication must be safeguarded from cyber-attacks and have fault-tolerant mechanisms in place to manage events like sensor malfunction.
Site Monitoring and Auditing – With Trials becoming hybrid and decentralized, sponsors need to look for technology that can facilitate remote source review and adhere to emerging ways of monitoring and auditing, as it is essential to measure the quality of the trials
Technology Complexity and Compliance Challenges – Leveraging a connected ecosystem driven by intelligent AI algorithms drives additional complexity like FDA approvals. Hybrid semi-automated approaches must be explored to ensure early adoptions.
Regulations – This is a relatively new area, regulations and guidelines continuously evolve. It is necessary to keep abreast of new regulations and keep investigators or sites informed of the updates.

The way forward

DCT is constantly emerging with newer technologies, and that can further expand patient centricity and reduce costs, such as:

AI/ML – AI/ML could be ubiquitous, spreading across all areas of clinical development. Potentially drive the Digital companion/Investigator to a patient in providing contextual recommendations and support to the patients undergoing trials. For sponsors, it can help determine eligibility criteria, recognize patterns, clinical data noise reduction, bio-markers creation, etc., to further ease development and research. Engaging the patient-based machine-driven algorithms based on clinical claims and SDoH data sets will be critical to reducing dropout rates and ensuring the efficacy of clinical trials.
Open-to-Trial (OTT) Databases – Tap into the patient networks or databases where patients volunteer information into the network to aid trial recruitment, so sponsors can proactively reach out to the subjects for trial participation through their preferred channel for communication. Use Geo-location to drive recruitment of patients based on open and priority databases.
User experience –Create Multi-lingual and intuitive mobile/ web apps leveraging design thinking to allow patients to manage all their trial needs in one location. Leverage technologies like NLP for ease of patient inputs or chatbots/Conversation AI (CAI) based engagement to up patient experience and retention. These apps can also be expanded as a digital supplement to the drug on commercialization. These apps can also be used as online collaboration forums to discuss clinical trial outcomes with caregivers, providers, peer subjects, and patient advocacy groups.
Integration – Integrate with clinical systems, wearables, and other systems to understand any recent updates to the participant's condition beyond the trial, notify the participant or investigator, and allow intervention or update the care plan as required. Leverage real-time integration with EHR systems to drive recruitment when patients consult with physicians.
On the fly analysis/edge computing – Process data from sensors and other products on edge to spot anomalies, respond quickly to an emerging situation, and provide clinical insights or alert an investigator.
Mixed Reality – Effectively train the participants to self-help using the systems/devices related to the trial and guide participants through sample collection procedures. Engage with fellow participants across the country/globe and allow them to participate in sponsor events.

DCT will continue to evolve with technology - with today's innovative features turning into essential/must-have features tomorrow.

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