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In the US, use of the Mitra device is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device can be used as a sample collection device for clinical diagnostic applications, as referenced in some content.

things to consider when pivoting to remote research studies

by Neoteryx | 4 min read

shutterstock_330465401-1Several vaccines for SARS-CoV-2, the virus that causes COVID-19 illness, have been developed, and are being made available. Because of this, many organizations are launching clinical studies to better understand how we respond to the virus itself, and also how we respond to the COVID-19 vaccines.  

Conventional clinical studies that occur onsite in facilities are not an ideal choice for the new infectious disease and vaccine studies because of the continuing high risk of exposure to SARS-CoV-2 in these environments. Instead, some researchers are turning to remote technology in order to conduct decentralized research studies and clinical trials. These virtual research studies provide an effective way to reduce the risk of disease transmission and also offer recruitment and retention benefits as well as cost savings. 

Conducting remote research studies involves unique considerations with which many researchers may not be familiar. If you are interested in running a remote SARS-CoV-2 study, but don’t know where to start, here are some points to consider.

6 Considerations When Launching Remote Research Studies 

1. Have you established a digital onboarding process? 

The first step to running decentralized studies and clinical trials is to provide volunteers with a way to enroll online. Your digital onboarding process should be secure, private, and compliant with HIPAA standards or other regulatory requirements. People should also be able to use online tools to schedule any necessary preliminary phone or video calls with research or trial staff. 

2. Is there a webpage for this clinical trial? 

Every remote clinical trial should have its own dedicated webpage to maintain public trust and transparency. This site should contain:

  • Description of the study and its goals
  • What will be expected of study volunteers
  • Registration guidelines
  • Relevant information
  • Staff contacts

Participants and other interested people should be able to use the web page to learn more details about the study and ways to get more information if they need it.  

3. Is there an online portal available for trial participants? 

Remote trial participants need a way to review and submit key information for the study during the time they are involved. An online portal offers a clear central location where trial volunteers can find in-depth information or fill out surveys and questionnaires easily, at any time.  

At a minimum, a clinical trial portal should include copies of all registration documents, including qualifying criteria questionnaires, safety fliers and consent forms. Additional information like FAQs (frequently asked questions) provides extra support for participants and better emulates the experience they would have during a traditional, onsite study. Some studies also use secure portals to allow patients access to their remote specimen collection test results from the study lab and other personal health data.

4. Is there a variety of remote data submission options available? 

Remote study participants must have a way to connect with study coordinators and submit their information. Most studies make extensive use of phone and video calls for interviews and Q&A sessions. This allows researchers to collect detailed personal data at a distance.  

You might consider adding different submission formats (online surveys, quizzes, and feedback forms). These will allow you to collect different types of data and allow your participants the flexibility of submitting responses on their own time. There are many platforms to help you do this, including Medidata, ICON, and Halo Health Systems

5. How will you use remote devices for sampling and monitoring? 

Collecting the necessary biological specimens and medical data to effectively conduct or manage a study is one of the biggest hurdles involved in running decentralized clinical trials. When using a remote study model, trial participants must be able to perform the specimen collection and/or data collection themselves. For this reason, the equipment they use must be precise, accurate, and easy to use.  

  • Wearable devices make it easy to monitor things like blood oxygen levels and heart rate by automatically recording data in a digital interface.
  • Technologies like Mitra® devices for remote specimen collection offer the most convenient solution to meet at-home sampling requirements by volunteers with minimal training or instruction. The devices are carefully engineered to absorb a small but exact sample of biological fluid (i.e., blood or urine). The samples can be repackaged in the included pouch and envelope, and mailed to research facilities for analysis using standard mail and shipping methods. There is a tiny sachet of drying desiccant included in the pouch with the bio-sample, which keeps it stable as a dried specimen during transit.

6. How will you provide remote training and orientation? 

Participants in remote research studies need access to training resources. This ensures they know how to perform their role effectively. It promotes higher quality sample collection and data input. Researchers running decentralized studies must provide extensive online training materials and documentation to help participants navigate all processes and procedures during the trial. This material can be placed within the trial’s central portal, and trial coordinators can also provide training materials and links via email.

In addition to written instructions, it’s a good idea to include multimedia elements in your training materials, including videos, diagrams and animations. The more formats you use to present the necessary information, the more likely volunteers with different learning styles and language skills will understand what they are being asked to do.

Remote Research Studies Help Overcome the Challenges of COVID-19 

Remote research studies offer researchers a new way to conduct studies and clinical trials, despite challenges imposed by social distancing, lockdowns and other restrictions. Is the remote approach better? There are multiple benefits compared to conventional onsite trial processes, particularly in the context of a global pandemic.

If your organization has been considering launching a remote SARS-CoV-2 vaccine study or immune response trial, make the process as smooth as possible for both your participants and your research team by designing an efficient remote/decentralized trial model.

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Originally published Apr 12, 2021 12:00:00 PM, updated on April 22, 2021

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