Virtualizing clinical trials can accelerate timeline, shrink budgets, and deliver better data, but many often wonder how to leverage DCT solutions in their studies. Find out how to implement DCT solutions at the 4 key critical stages in any trial with our no-nonsense guide below.
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1. Fully remote vs hybrid models
All studies are not created equal. Different products, therapeutic areas, and endpoints (or should it be outcomes) will all require unique study designs. But all clinical trials can benefit from some virtualization—because virtual means faster. (Because virtualization equals speed)
If the goal is to capture data on people's perceptions of a product or substantiate the improved quality of life claims, your study is likely right for a 100% virtual design.
Some trials will require site or doctor visits but can still benefit from integrating virtual methods. The goal is to identify touchpoints that can be enhanced with decentralized solutions.
2. 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 costs 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.
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.
Virtual trial monitoring allows for KPIs 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.
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 the versatility to conveniently report worrisome symptoms (AE/SAE) immediately.
4. Recruitment & Enrollment
In a decentralized clinical study, recruitment and enrollment are also conducted remotely. This virtual approach offers some meaningful benefits/advantages when compared to traditional methods. The digital recruitment and enrollment models break down many of the barriers to clinical research, are often more inclusive, faster, and more cost-effective.
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 are not registered in a patient catalog but may be suffering silently with a disease.
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.
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.
How virtual can your trial go?
Each DCT component of a clinical trial can be seen as a stepping-stone to better data. Digital recruitment provides sponsors an effective means to identify ideal candidates from a broader pool. Digital enrollment enables participants to comfortably sign on to studies while 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 if your trail can go virtual, but rather how virtual can your trial go?
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