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Conducting a Fully Virtual Clinical Study: Lessons Learned

As COVID-19 swept the nation, many traditional operations of healthcare institutions shut down. Elective surgery, traditional in-person checkups, and non-emergency patient transfers were all (understandably) postponed to free up resources for crisis-response. Nationwide, healthcare institutions were bracing for an imminent tidal wave of patients.

In the scramble to batten down the hatches, many crucial but less publicly known functions of healthcare systems were also shut down, including clinical research.

This move made a lot of sense, as many clinical studies have in-person patient visits. These visits are one more vector for a potentially infected person to enter the clinic or for a healthy person to get sick. Research institutions made the correct choice to put their studies on pause. While strategically the correct decision, there was a trade-off, and the price we pay is halting billions of dollars of clinical research and development in its tracks.

At VitalFlo we found ourselves in this very situation. The clinical coordinators for our own studies were advised to halt in-person visits. Then we started hearing from our friends at the other large research institutions around the country. Their studies would be on pause until further notice. An entire sector of the economy was grinding to a halt.

But this embargo was not meant to halt research altogether: we simply can no longer conduct in-clinic visits. So we put our heads together:  researchers, technologists, and healthcare professionals have solved plenty of challenging problems together. Surely we can find a viable way to work through this problem.

At VitalFlo, and in partnership with our colleagues at academic research institutions, we set to work on developing a solution. In our pursuit, we had one very large ace up our sleeve: as a digital health company, our mission is to provide clinical quality data for clinicians while the patient is safely at home.

Furthermore, with clinical deployments and research institutions across the country, we had conducted fully virtual deployments and care before. Some of our earliest work was a partnership with a large academic research institution to launch a fully virtual study.

Pre-COVID, this was seen as a novel technique to get a very diverse patient population and remove one of the key barriers to participating in clinical research (the need to visit the research site for clinic visits). Now, it is how we would get research up and running again.

In short, we were fortunate to have developed a playbook for taking a study remote before COVID-19 hit, and we are now putting it into action. What I want to layout are the major barriers we had to overcome in the transition, and how to overcome them:

Costs

Unless you are already set up to collect all of the data you need for your study virtually, there will be costs associated with transferring your study to fully remote.

These costs can range from the straightforward (data collection tools & medical devices) to the inane (full-stack telehealth solutions for your observational study). Before drawing up a new budget approach vendors with a collaborative mindset. Most will not have experience with this situation but, all of us want research to continue.

There is a solution depending on the level of sophistication you need for your study. Anything less and you may not accomplish your endpoints, anything more and you are wasting precious time and funding. A good solutions engineer will be more than happy to talk you through the possible solutions and what makes the most sense for your study.

It never hurts to get a second opinion. The IT staff at your institution will have a good understanding of the complexity involved in whatever implementation you need. If there’s not a good solution apparent, contact me, we will find a partner.

Security and Privacy

Data security and patient privacy should be at the forefront of every healthcare technology provider’s mind. Ultimately the decision as to whether or not the service you are looking to implement is secure will be up to the Information Services/ Information Technology team, but involving that team takes time and many of their questions are standard.

This topic can get dense quickly, but here is a cheat sheet for a few key things you should consider:

The Nonstarters (if they say no to any of these just walk away):

  1. Is the solution you are looking to implement HIPAA compliant?
  2. Do you have subjects in Europe? If so, make sure to ask for GDPR compliance.
  3. Is the data encrypted in transit and at rest?
  4. Are all internet connections to or from the technology secure (over HTTPS)?

The Details (if they pass the first test, make sure to get documentation on the following):

  1. What are their security policies?
  2. Do you have a security packet for the institution’s technical team to review?
  3. Do you have any security certifications?
  4. Will your team agree to a security review?

Other Considerations (depending on your specific needs, these may also be useful questions):

  1. Are they based in the US? Their technology has to be for HIPAA compliance.
  2. What is there attitude being asked the questions above? (i.e., are they cagey or dodgy?)
  3. Does their company have a professional presence? (e.g., professional website, proper email footers for confidentiality, Linkedin page.)

Data Quality

While capturing data remotely, especially in the case of physiological measurements the quality of the data will be the most important factor in choosing a partner. One day a week of high-quality data is better (in most cases) than several poor data points.

Make sure you can demo the vendor’s technology before buying it. If you cannot collect high-quality data on yourself how likely is it that anyone else could get it right? Ask to meet with the clinical validation team of the company and their head of product/head of data.

Many digital health companies have created gimmicky games and pestering alerts. Games work in some cases, but only if they are built around a robust data collection and analysis effort. Data collection tools optimized for a fun user experience can sometimes compromise data accuracy. (A good rule of thumb: if the alerts are annoying to you, they will also be annoying for the patient.)

When in doubt ask for the case studies. If the company has worked in research before they should have an abundance of data on how accurate their tools actually are.

We are here to help

There are, of course, other considerations. Your mileage may vary, but what I wanted to layout here is the groundwork upon which you can build your action plan.

If your study is in the respiratory space, contact me we will work together to get your study on track. If you have any questions reach out to me I am happy to chat with you (ryan@vitalflohealth.com).

We are here to help. Even if your study is not in the respiratory space we have partners and peers across the industry who can help.

Fully Virtual Studies: Setting Your Institution Up for the Future

Transitioning a study to fully virtual is challenging, but necessary. With conversations around the country and across economic sectors on “the new normal”, it is time to begin that conversation for our most important industry.

While COVID-19 is the latest hurdle, clinical research has always been fraught with challenges. The largest barriers to clinical research have historically been those which can be overcome with this new approach to research. By transitioning out of necessity I believe that we will be able to enable and ultimately expand clinical research far beyond what was previously thought possible.

Additional Resources

Digital clinical trials: creating a vision for the future — Nature

Digital Clinical Trials Workshop: Creating a Vision for the Future — NIH

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