Decentralized Clinical Trials: Finding the Best Technology Partner

Broadly speaking, there are three types of decentralized trials, and having the right technology partner can help with all of them:

• Decentralized clinical trials (DCTs)
• Virtual clinical trials
• Hybrid clinical trials

Let’s start with some definitions.

Decentralized Clinical Trials

A decentralized clinical trial is one in which the sponsor does not rely on the traditional role of the site to carry out the study protocol day-to-day. DCTs use technology to communicate with study participants and to collect data. Although all the activities of a DCT are conducted remotely and away from central study sites, they are not necessarily fully virtual. By partnering with community doctors and mobile health networks, caregivers can perform patient treatments in person. Virtual technologies are needed to support DCTs such as remote learning on the clinical trial protocol for practitioners and caregivers; digital transmission of data and collected outcomes; and virtualization of patient enrollment and other processes. These technologies can be more challenging and time-consuming and therefore push study stakeholders away from implementing a DCT model.

Virtual Clinical Trials

A fully virtual clinical trial is completely technology-based. This means there are no traditional sites, no physical locations used, and no face-to-face interactions. This modality poses some major challenges.

First, the nature of the investigational treatment itself may prevent the trial from being virtual, e.g., requiring surgery. Outfitting participants with the necessary technology – such as medical grade sensory/wearable devices like the Dexcom Continuous Glucose Monitoring (CGM) Systems or Orpyx, an ambulatory gait monitoring pressure sensor – and ensuring these tools are working and used appropriately is a hurdle.

While the convenience of not having to travel to a site may be appealing to busy patients, the bar is higher for ensuring quality and compliance and the lack of caregiver contact could have an unintended adverse impact on the patient. Although the virtual model may be tempting, it requires upfront work and investment from the sponsor.

Hybrid Clinical Trials

The promises of decentralized and virtual trials include expanding the pool of potential participants, accelerating recruitment, streamlining data collection, and cleaning, and cutting out middlemen.

The way one carries out a trial will likely fall somewhere on the spectrum between no virtual components to all virtual components. What if one sees an opportunity for a trial to be decentralized or virtual, but still require some central sites? Or maybe one needs at least one in-clinic visit for a procedure or test? This is the most common scenario for today’s clinical trials.

Rather than thinking about technology use as an all or nothing proposition, a hybrid approach is often easier for study stakeholders to adopt. Especially if you are new to virtualization/decentralization, start by identifying which components might be easiest to virtualize, such as a follow-up outcomes assessment that can be performed digitally and remotely via questionnaires or a single blood draw is needed and can be done by a mobile phlebotomy service.

Clinical Trial Technology

Whether a clinical trial is decentralized, virtual or hybrid, technology is necessary. There are number of technologies commonly used in today’s clinical trials, including:

• EHR eSource Integration which automates source data acquisition from patient medical record systems, e.g., EHRs and EMRs, to clinical trial research databases (EDCs) and case report forms (eCRFs) at scale.
• Electronic Data Capture (EDC), the workhorse of decentralized clinical trials, is software used for collecting clinical trial data.
• Electronic Patient Reported Outcomes (ePRO) enables the receipt of data from trial subjects anytime, anywhere, on any device, offering a frictionless way for patients to engage.
• eConsent is the use of interactive, multimedia components to empower patients to make informed consent and decisions (eICF).

Four Key Factors to Select the Right Technology Partner for Decentralized Clinical Trials

The use of technology in decentralized, virtual and hybrid clinical trials means clinical trials need a systematic way to evaluate technology vendors.

In our experience, there are four key factors to consider when evaluating technology partners:

1. 1. Software

      Start by listing and then prioritizing requirements, which will serve as a shopping list. Keep in mind that while it is important to check off a certain number of requirement boxes, it is also critical to realize that the toolset itself is not the sole determinant of a successful clinical trial. Having a box full of hammers, saws, and wrenches does not mean one is able to build a house. It’s vital to know how reliable the system is. Can the features you need sufficiently scale and adapt? Evaluating ease-of-use is particularly difficult to distill into written requirements. Ask the vendor you’re considering to provide a sandbox where you and your team members can get hands-on with the software.

   2. Support

      Every clinical study requires a certain level of support when it comes to onboarding new technology. How much time is required for implementation? What skills and resources are required? What does training look like? You’ll need more than just responsive tech support. The chosen vendor also needs to make it easy to demonstrate ongoing compliance with regulations such as ICH GCP, 21 CFR Part 11, HIPAA, and GDPR.

   3. Professional Services

      Most technology companies offer a variety of professional services. Be sure to investigate the availability and expertise of the support personnel that will be key to your success. Search for a technology partner that hires and trains people with field experience, such as former clinical data managers or clinical research coordinators. You are bound to have a much better experience working with a company whose people understand what it’s like to be in your shoes.

   4. Cost

      Cost is always a critical factor. Consider the direct cost of the software but also the impact of associated costs such as data entry/cleaning costs, monitoring costs, and site payments. The correct way to assess costs is to look at them holistically.

At OpenClinica, we offer a free trial of our decentralized clinical trials technology solutions. To start your free trial, visit: https://www.openclinica.com/#demoform.

For more information about DCTs, download our eBook, Your Blueprint for Decentralized Clinical Trials.