Decentralized Clinical Trials: Are Remote Elements Right for Your Next Study?

The US Food and Drug Administration recently published a new guidance on conducting clinical trials with decentralized elements. The guidance offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.

By issuing this guidance now, FDA is acknowledging the growing role the digital health technologies (DHT) play in medicine and the potential for more clinical trials to occur away from traditional research settings. Given that decentralized clinical trials (DCT) are clearly on the FDA’s radar, it’s worth taking a closer look at what decentralization entails, how it can help sponsors and participants, and what FDA recommends for carrying out studies remotely. 

BONUS RESOURCE: Click here to download a free resource bundle for clinical investigations.

What are decentralized clinical trials?

A decentralized clinical trial refers to a trial where some or all of the clinical activities happen at locations other than a traditional study site. Those alternative sites could include study participants’ homes, a nearby lab, or a local healthcare facility. 

The decentralized elements of the trial are carried out using digital health technology that can capture and/or transmit patient data safely and securely. The DHT umbrella covers a wide variety of technology, from wearable devices like from blood glucose monitors to telehealth and electronic patient reported outcome (ePRO) software. FDA has also published a guidance document on the use of DHT in remote data acquisition in clinical investigations, which provides recommendations for using DHT in a secure and compliant manner. 

Given the FDA’s emphasis on security and compliance in DHT, it’s important that sponsors select an EDC system that is designed with these features in mind, like Greenlight Guru Clinical. Our EDC has built-in compliance to regulations like 21 CFR Part 11 and comes with a suite of features that support safe, reliable, and secure remote data collection. With Greenlight Guru Clinical, sponsors can have peace of mind, knowing they’re always meeting the latest FDA guidelines for decentralized trials and DHT.

What are the benefits of decentralized clinical trials?

It should come as no surprise that most people would prefer to receive treatments either in their own home or at a nearby location that minimizes travel. The major benefit of DCT is that it reduces physical and social barriers to participation by reducing or eliminating travel and providing care at a time and/or place that is more inclusive for a wider range of participants. 

Older individuals, those living in areas without clinical research facilities, or people who are simply not able to make time to participate are often excluded from research due to geographical or scheduling barriers. This leads to underrepresentation, often of racial and ethnic minority populations, resulting in a lack of critical data for sponsors.

But by enabling remote participation, DCTs can reduce those barriers and allow for more inclusive study recruitment while potentially improving participant engagement. Decentralization also facilitates research on rare diseases that would typically require extensive travel for most participants. 

Why is FDA focused on decentralized clinical trials and digital health technology right now?

FDA guidance documents provide the industry with the agency’s current thinking and recommendations on a given subject. The publication of a final draft can take several months, so a guidance document is, in effect, a statement of a topic’s importance to the agency.

And right now, the potential for DCTs is growing quickly enough that it makes sense for FDA to provide guidance on the use of decentralized elements in clinical trials.

Two factors have driven the increase in DCTs and the use of DHT. The first is an improvement in the technology that sponsors and investigators now have at hand. It’s now much easier to collect, transfer, and securely store electronic data than it was even a decade ago. And DHT is only getting better, leading to more opportunities for the remote collection of data. 

The second driver of DCTs is an increased comfortability (on the part of both participants and clinicians) with the use of digital health technologies and telemedicine in general. Even among older populations, smartphone use has increased dramatically, and telehealth is becoming a more regular feature in patient care. 

The travel restrictions required by the COVID-19 pandemic were an additional catalyst, as they forced sponsors to assess their options for remote monitoring and data collection, as well as other elements like electronic informed consent. 

BONUS RESOURCE: Click here to download a free resource bundle for clinical investigations.

What does the FDA's guidance document on DTC tell us?

While DCTs may be more flexible and convenient for participants, nothing changes in regards to the sponsor’s responsibilities. The guidance document unequivocally states that, “Sponsor responsibilities are the same for trials that include decentralized elements and trials that do not include decentralized elements.” 

In fact, elements such as a comprehensive data management plan, the trial monitoring plan, and the coordination of contracted services (like personnel for at-home visits), mean that decentralized trials will require at least as much planning as traditional studies. 

Using electronic systems in trials with decentralized elements

Section J of the guidance document is devoted to the use of electronic systems, and given their importance in decentralized clinical trials, it’s worth reading carefully. Some points here to note:

• Electronic systems can be used to perform many functions in a DCT, including:
  • Obtaining and managing informed consent
  • Managing electronic case report forms (eCRFs)
  • Scheduling trial visits and other activities
  • Capturing and storing reports from remote trial personnel, health care providers, and clinical lab facilities.

• Local healthcare providers can send forms or documents electronically that can then be entered into eCRFs. Or, to simplify the process, an eCRF can simply be designed to allow local providers to enter trial-related data directly.
• Electronic systems that are used to produce and process trial records must be compliant with 21 CFR Part 11 and ensure data reliability, security, privacy, and confidentiality.

So, as you begin looking for electronic data capture (EDC) systems to facilitate DCTs, it’s important that you understand not only their capabilities, but regulations they comply with and the measures they take to ensure the safety and security of your clinical data.

Greenlight Guru is the modern EDC system for decentralized trials

Decentralized clinical trials introduce new challenges for data collection, management, and compliance—but choosing the right electronic data capture (EDC) system can make all the difference. Greenlight Guru Clinical is designed specifically for MedTech, providing a secure, compliant, and intuitive platform to support your study’s remote data needs.

With Greenlight Guru Clinical, you’ll have the flexibility to design custom electronic case report forms (eCRFs) with data validation rules and question visibility options that reduce errors and ensure quality data capture, even from remote locations. For patient-reported outcomes, our platform’s secure ePRO features allow you to send forms and reminders through SMS or email, making it easy for participants to respond at their convenience.

Whether you’re managing local healthcare provider data submissions, coordinating remote visits, or monitoring data collection in real time, Greenlight Guru Clinical brings all the tools you need into one streamlined platform. We meet rigorous regulatory standards, including 21 CFR Part 11 compliance, so you can focus on what matters—advancing your study, not managing the technology behind it.

Ready to simplify your decentralized clinical trial? Get a free demo of Greenlight Guru Clinical today and see how we can support your team every step of the way.