Rapid digitalization and advancement of modern technology have driven pharmaceutical companies to design a more sustainable approach to conduct clinical studies by introducing the concept of patient-centric decentralized clinical trials (DCTs). The technology and infrastructure currently available today are promising for conducting DCTs where sponsors/ CROs can move away from the traditional site-anchored clinical development.
After the COVID-19 pandemic disrupted several ongoing clinical trials, companies were forced to rely on the immediate adoption of virtual collaboration and communication technology to continue the drug development lifecycle. This phenomenon laid the foundation to start adopting the concept of DCTs where principal investigators and patients can continue their interactions in a digital environment at their own convenience.
During the COVID-19 pandemic, the FDA had itself permitted sponsors to conduct remote clinical trials for oncology clinical trials. The FDA has also clearly stated that although there was no formal regulatory guidance published to detail the permissible process, it is keen to understand and learn about the reality of benefits and risks of this novel approach.
The only mandatory obligation for sponsors was to accurately flag datasets that were generated with remote engagements and those with in-person subject interactions (FDA, 2021, April 12).
Overview of Decentralization Clinical Trials
Today, the concept of DCTs is used almost synonymously with words such as virtual, home, remote, distributed, and home-based or site-less trials. In general, a decentralized trial can be characterized as a hybrid model that uses a combination of traditional and virtual trial elements rather than a specific type of approach. It is important to note the goal of DCTs is to simplify the patient-physician engagement but this does not mean that all clinical trial interactions are limited to a virtual setting. The hybrid approach encourages personal meetings depending on the context of different clinical trial events.
In all the variations of DCTs, “patient-centricity” has remained the primary area of focus for sponsors and CROs. As participants will have ease in participating remotely, a higher retention rate can be expected during the course of the clinical trial. Therefore, DCTs can be considered as a potential patient-focused approach to clinical trial design. Here’s how they are faring currently and what is expected of them as they evolve.
How Modern Technology facilitates the conduct of DCTs
Today, technology innovation has made virtual interactions seamless with a close-knit digital connectivity with real-time video conferencing using powerful smartphone apps. The explosion of intelligent health monitoring wearables and sensors and interconnected electronic medical records systems have considerably transformed data collection and sharing. DCTs use these “virtual tools” to grow in parallel with “virtual medicine,” accelerating clinical trial design.
In a fully decentralized clinical trial, patient recruitment, delivery of study medication, and procurement of trial outcomes data all proceed without involving in-person contact between the investigators and the patient. Currently, clinical trials for drug approval already include decentralized elements and their contribution continues to grow.
Current state of DCT adoption
A recent study found 76 percent of investigators are now performing decentralized trials due to the pandemic, with 38 percent representing more than half are decentralized. Thus, it is imperative to employ this approach to ensure patient safety, retention and effective trial participation during the pandemic.
Telemedicine applications, wearable devices and other technological support systems have been contributing to the move to DCTs even before the current crisis. FDA approved devices have been in real-time adoption to monitor patients with rare diseases and special needs. However, it is clear that the pandemic has been a key driver for DCT adoption. In its current state, the contribution of individual technologies for DCTs has been identified as follows:
- Mobile technologies with the greatest means for patient access have been used in 77% of the DCTs
- Wearable devices have been used in 60% of the cases
- In-home devices are actively being used in 54% of decentralized studies
- Sensors and AI/ML have been used in 35% and 31% cases respectively
- Other uncategorized technologies were also found in 9% of studies
Establishing the site-sponsor connection for DCTs through software integrations
A decentralized approach replaces several site visits for patients with a healthcare provider (HCP) making a home visit, or with an online mobile application that facilitates data collection without needing patients to attend the site. This is made possible through software integration and virtual collaboration between the researcher sites and local medical teams, enabled by digital technologies. This connection allows research sites to receive accurate patient data from local physicians’ offices, pharmacies which can then be shared with their sponsors. According to a recent study by WCG, 97% of the research sites are anticipated to use at least one remote monitoring tool to connect with their sponsor. The software integration for site-sponsor connection will impart the following benefits:
- Real-time monitoring: Real-time monitoring allows sponsors to monitor site’s progress without having to visit the site in person each time.
- Instant document and data exchange: Sites can upload their regulatory documents, lab results and other essential documentation to a secure online database. This allows sponsors to view documents without waiting on emails or faxes and can electronically share eTMF documents with sites as needed.
- Automated workf