How-To Guide for Decentralized Clinical Trials

Most of our prospective clients understand that virtual represents a new frontier in clinical research but often ask how to implement virtual solutions into their studies. Is this you? Maybe you already have a written protocol and want to gauge the possibility of a virtual transition, or perhaps you want first to determine the most effective trial design. Because these are scenarios we see so frequently, we thought we could offer a playbook to help you imagine your studies in a virtual way. Here are four big-ticket items that will impact how your study proceeds.

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1.  Study Design

All studies are not created equal. Different products, therapeutic areas, and endpoints will all require unique study designs. But, all clinical trials can benefit from some virtualization to avoid the roadblocks that typically slow studies down.

Fully Remote Trials

If your primary endpoint is ePRO-related or can be accurately captured remotely by an in-home device or home testing kit, your study may be appropriate for a 100% virtual design.

Hybrid Clinical Trials

Some trials will require site or doctor’s visits but can still benefit from integrating virtual methods. The goal is to identify touch points that can be enhanced with decentralized solutions. 

2.  Recruitment and Enrollment

In a decentralized clinical study, recruitment and enrollment are also conducted remotely. This virtual approach offers some meaningful benefits and advantages when compared to traditional methods. Allowing for digital recruitment and enrollment models in your clinical trials can break down many barriers to clinical research—making your clinical trials more inclusive, faster, and more cost effective.

Untapped Patient Populations

With decentralized clinical trials, geographic boundaries evaporate, leaving recruiters with a much broader pool of potential participants to meet inclusion and exclusion criteria. By reaching out to people who would otherwise not be solicited, virtual trials can recruit those who live too far from a lab/clinic or those who are not registered in a patient catalog but may be suffering silently with a disease.

Informed Consent Without the Pressure

Instead of requiring participants to review and sign consent forms face-to-face with an HCP, digitizing the consent process (eIC) allows patients to review at their own pace. And, including multiple ways to engage patients 1-on-1 can help increase their understanding of the clinical trial and their personal responsibility in it.  

Virtual Patient Training for Higher Compliance

The better a participant understands their responsibilities at the outset of a trial, the more likely they'll be to comply with the protocol, provide accurate reporting, and complete the trial. Educating patients on how to provide accurate information can also reduce the placebo effect. When doing these trainings virtually, quizzes, recaps, and other learning strategies can be incorporated to ensure participants comprehend and retain the training information before beginning the trial. 

3.  Study Monitoring

Advances in data collection require advances in study monitoring. In a world without paper, information captured digitally by trial participants and providers can immediately transfer to an electronic data record and be monitored 24/7.

Dashboards

Virtual trial monitoring allows for KPI metrics to be analyzed in real time. This enables the study team to detect problems before they become protocol amendments. For example, because they can immediately visualize the data, a study team can quickly detect rising rates of non-adherence and investigate possible causes. 

An example of what a customized study dashboard may look like for an ObvioHealth client (on tablet).

Safety Monitoring

With virtual solutions, clinical trials have never been safer. Real-time monitoring allows researchers to pinpoint a potential AE as the data comes in, while telehealth visits and live chat functions provide patients with the versatility to conveniently report worrisome symptoms (AE/SAE) immediately.

4.  Data Collection

Virtual data collection is one of the most innovative areas in the clinical trial space, enabling the collection of more data than ever before—faster and in real time. These advances in data collection are truly revolutionary, and finding ways to incorporate these methods can greatly enhance your study.

ePRO has been around for a long time, but now patients can report outcomes on their personal devices. This greatly saves on cost for the sponsors and often increases patient compliance because it eliminates the need for participants to carry around additional devices. It also reduces the learning curve associated with using new devices for the first time.

Incorporating AI and machine learning into studies can provide an unbiased interpretation of reported outcomes. Artificial intelligence can reveal participant recording inaccuracies and provide additional unobservable parameters of a patient's condition. As you plan your study, it's important to think about the different ways to reduce bias from your data sample to increase the likelihood of obtaining valid efficacy/claims.

With digital devices, patients can give blood samples, measure their heart rates, and even take ECGs from home. There are also a growing number of digital devices that are made to passively capture information on vital signs and activity levels, resulting in real-time data capture. These convenient data capture solutions save time, decrease overhead costs, and result in better data.

It is essential to train patients on concepts such as accuracy and honesty in reporting, as well as the importance of ePRO compliance and medication adherence. In addition, subjectivity is reduced whenever possible by using patient images, audio, video, or wearables and biosensors to ingest patient data streams. Patient data can then be reviewed and scored by central expert raters to reduce inaccuracy in reporting.

How virtual can your trial go?

Each DCT component of a clinical trial can be seen as a steppingstone to better data. Digital recruitment provides sponsors with an effective means of identifying ideal candidates from a broader pool. Digital enrollment enables participants to comfortably sign on to studies while also offering support when and if needed. ePROs enable real-world data capture outside of the sanitized clinical setting. Each component plays a crucial role in constructing a time-efficient, cost-effective protocol design that can deliver more and better data. The question shouldn't be whether your trail can go virtual, but rather, "How virtual can your trial go?"

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