As the world navigated the challenges posed by the SARS-CoV-2 virus, a paradigm shift in clinical research emerged. The SARS-CoV-2 episode underscores the vital role of virtual or remote research studies. Drawing insights from this era, this guide offers foundational steps to initiate remote clinical research across various fields.
The Rationale for Virtual Clinical Studies
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Safety & Convenience: Reflecting on the SARS-CoV-2 crisis, the traditional model of onsite clinical studies was evidently risky. Remote research not only ensures the safety of participants but also provides unparalleled convenience.
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Cost-Effectiveness & Efficiency: Beyond the safety advantages, remote specimen collection inherently presents a cost-efficient model, and positions a clinical study for improved recruitment and retention.
Foundational Steps for Launching Virtual Studies
1. Initiate Digital Onboarding:
- A secure, compliant, and user-friendly onboarding system is the bedrock.
- Participants should be able to schedule calls or virtual meetings with research teams with ease.
2. Establish a Dedicated Webpage for the Study:
- Maintain public trust with a transparent, informative webpage.
- Essential inclusions: Study objectives, participation requirements, registration processes, and staff contact information.
3. Implement a Secure Online Portal:
- Participants require a centralized hub for all study-related interactions.
- The portal should house vital documents, FAQs, and even personalized data, safeguarded with top-tier security.
4. Offer Flexible Remote Data Submission Channels:
5. Integrate Reliable Remote Data Collection Tools:
- Drawing from the SARS-CoV-2 experience, wearable device became indispensable for real-time health monitoring.
- Remote sampling tools like the Mitra® device enabled participants to contribute samples without any professional intervention.
- Establish standard procedures for mailing and analyzing these samples.
6. Provide Robust Training & Support Materials:
- Offer easily accessible online training resources.
- Leverage multimedia - from written guides to instructional videos.
- Address the diverse learning needs of participants to ensure quality data collection.
Remote Research Studies Help Overcome Challenges
Remote technologies offer pharmaceutical companies and research organizations a new way to conduct research studies with more convenience and efficiency. Remote or "mail-in" approaches are particularly helpful during times when people are reluctant to travel to hospitals or other medical facilities.
Many scientists learned the value of remote research studies and portable technologies during the COVID-19 Pandemic. They used Mitra devices paired with telehealth communications to continue their studies without interruption, even during lockdowns, social distancing, and other restrictions.
From Retrospection to Forward-Thinking
The SARS-CoV-2 pandemic was a touchstone moment for clinical research, revealing the potential of remote methodologies. As we look forward, the insights from this era can shape future clinical trials, making them more adaptive, efficient, and participant-centric.
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