Virtual trials are more prevalent than ever. Sponsors and CROs are exploring study design and processes that accommodate or require virtual or hybrid components, and sites are looking for innovative ways to interact with patients in a pandemic environment where traditional office visits are not always feasible. This transition is a challenge for any site; so as you make this switch, we have outlined a few questions that you should ask your site before taking the plunge with new technology and new studies dealing with virtual trials.
- Is My Site Setup Conducive to Virtual Trials?
This is a complex but essential question to answer. You have to take into account your current site setup (staff, team qualifications, technology in-place, etc.) before agreeing to your first virtual or hybrid trial. These decentralized trials require new tools, some owned by the site, some potentially owned by the Sponsor. New technology means new processes, new training, and new responsibilities for everyone on your staff. Change is essential, but if your team struggles to embrace change, virtual trials will be a difficult adjustment. If you are hoping to make this change sooner than later, make sure your staff know about the upcoming changes and are clear about their roles in the required transition.
- Does My Site Have the Capacity to Handle Virtual Trials?
Again, virtual/hybrid trials mean change. The traditional office-hours-visit is no longer a guarantee, which means your site and your staff have will have to have a plan to handle weekend virtual visits, off-hours visits, collaboration with home health services and aiding participants in conducing simple procedures (live vitals) while they watch. Your site needs to have a plan for these changes to everyday office life and ensure everyone is on the same page before starting the first virtual clinical trial.
- Is My Site Ready to Assume the Cost Structures of Virtual Trials?
The technology from virtual trials means different costs than paper and storage. It’s important to know who assumes these costs and how they factor into the final agreement with the Sponsor. If Sponsors are expecting your site to use new tools, are they providing them? Does it make more sense for you to own the tech and bill each Sponsor? What about training; is that covered?
- Has My Team Carefully Read the Contracts for My Potential Virtual Trials?
It’s important that you get a clear understanding of each virtual trial agreement, especially if new technology is involved. Leveraging Sponsor-owned tech vs. site-owned tech is a complicated determination to make for your site, and both have pros and cons. Be sure to understand what compliance and regulatory hurdles your site is responsible for surrounding technology you own and for technology the sponsor owns.
- Is My Patient Population Open to Virtual Trials
In the end, it all comes down to the needs of your participants and patient pool. Are they the right population group who would be open to having telehealth meetings, taking their own vitals or working with home health caretakers? Do the conditions your trials focus on allow for virtual/hybrid visits? Your internal company goals are one thing, but if your participants can’t or won’t embrace the change to virtual, then your site should reconsider the timing to make the move to virtual trials.
The push for virtual and hybrid trials is coming from sites, Sponsors and participants. As all sides adapt, it’s important to remember to be flexible. If there’s something you don’t like about a Sponsor’s proposed virtual trial agreement, ask to change it, or see if they can be flexible to consider the needs of your site. Right now, that transparency and flexibility go a long way to furthering how research gets done in the current environment. Good luck!