Early Lessons on Virtual Trials

Last month, Applied Clinical Trials spoke with Craig Lipset, Head, Clinical Innovation at Pfizer, about the current status of the REMOTE trial. Background articles on REMOTE and the participating vendors can be found in the August 2011 through November 2011 News sections.

Craig Lipset is Head, Clinical Innovation at Pfizer.

What is the status of the REMOTE trial and what has been the general response to date to the virtual trial model?

There is different data that we'll come out with over the course of the year sharing some of the status of the REMOTE trial in different settings. What I'll say right now is that we've had great support from our technology partners. We've had great support from regulators and ethics committees. We've had some challenges in terms of getting significant numbers of patients into the study. And that's okay because, in large part, if everything worked perfectly, then either we were geniuses or we didn't push the boundaries hard enough.

While we may be smart, I think that we really wanted to make sure that we were pushing the boundaries here. And so we do view this as a learning project, where there are recruitment channels that we're exploring that are not delivering. We're capturing that data and reacting to it in real time and being able to make modifications in real time.

So there's a great deal of learning that's been happening over the recent few months around recruitment channels. In particular, where recruitment is entirely online and looking to see which ones are able to deliver this particular patient population, which is a unique population. These are patients that have to be very highly engaged, perhaps more so beyond that of a typical patient.

With your experiences to date, do you have any takeaways that you could provide for others looking to move toward a virtual model?

Make sure that the patients feel supported and that the process is as simple as possible.

By feeling supported, recognizing that in this model patients are not having that in-person physical engagement that they're most comfortable with. And while many patients are comfortable doing a lot of transactions online, we have been educating consumers for years not to trust the Internet and not to trust sharing things over the Internet. And so we can't just step right in and say, "Well, don't trust anyone else, but you can trust us."

REMOTE Virtual Trial Stats and Facts

So I think that we need to make sure that patients still feel a level of support. The intent with this model is not to say that there is no contact allowed with patients. The intent of the model is to make it more accessible and convenient. So phone conversations are completely fair to have. We have some experiments we're doing with visiting healthcare providers to the patients. I think as long as we're staying true to that goal of making the trial more accessible and convenient, we can do other things to make sure that the patient feels supported and well-engaged.

Around simplicity, clinical trials are complex. Informed consent forms are complex. And so everything that we can do to help mitigate that complexity, help make sure that things are both readily comprehensible but also that the workflow is simple, I think that those are important, early takeaways.