REMOTE is the first-ever randomized clinical trial under an investigational new drug (IND) application in which the study is managed entirely using electronic tools and allows subjects to participate in the clinical trial regardless of their proximity to clinical sites. Pfizer’s pilot project uses mobile phone and Web-based technology to collect necessary data for the trial, without clinic visits. The trial was announced last June. And this month ACT, Editor-in-Chief Lisa Henderson talked to Craig Lipset, Pfizer’s head of clinical trial innovation, to see how REMOTE has been progressing. Mr. Lipset had interesting things to say about recruitment in this newest of new models:
What has been the general response to date to the virtual trial model?
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. We view this as a learning project, so 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.
What have been the challenges?
In particular, it has been the channels where recruitment is entirely online. It is a unique population and we are looking to see which ones are able to deliver. These are participants that have to be very highly engaged, perhaps more so than what is beyond expected of a typical subject.
Do you have key takeaways that you could provide for others looking to move toward a virtual model?
Make sure the subjects feel supported and the process is as simple as possible. Participants in this model do not have that in-person physical engagement, which helps to make subjects feel comfortable. And while many subjects 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.”
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 going to the patients. So I believe 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.
You also mentioned simplicity.
Clinical trials are complex. Informed consent forms are complex. And so everything that we can do to help mitigate that complexity; to help make sure that things are both readily comprehensible but also to make the workflow simple is important.
How do patient-centric or at-home study services impact overall clinical trials in the future and even now?
For the US project, we don’t have necessarily a visiting nurse to every patient, but we do offer in-home phlebotomy for the patients as an alternative to going to a drop-in lab. For other iterations on this, we are looking at using other types of healthcare providers, visiting nurses, even the potential for visiting physicians in the patient’s home; which despite what sounds like an expensive proposition, when you look at the economics of setting up a single investigator site and the probability that that site may produce zero patients for your study, the economics of sending a physician to the patient’s home really aren’t so off-putting.
What does the term patient-centricity mean to you?
It’s a bit of jargon that it’s hard to disagree with, right? Who could raise their hand and say, “No, I don’t want to be patient-centric”? But I think what we’re really talking about here is that shift in mindset from viewing the patient as a research subject, an object from which we extract data, and shifting that to making that patient a real participant in a research process—how we engage them differently, how we share with them.
The real etiology for me around this is the shift in healthcare from patients becoming just sort of a one-way direction for healthcare providers to push information and prescriptions, to becoming participants in their healthcare. And I think that’s really exemplified in the E-patient movement, it’s exemplified when we see things like the Society for Participatory Medicine, and the new role that patients want to play as an empowered partner in their health.
And when we see that in healthcare, we then look and carry that over to clinical research and say, “Well, historically it was okay, I suppose, for patients to just sort of take that same model of one-way direction. We’re extracting data from them. But in this new world where patients are looking to be participants in their health, how do we carry that spirit over into research and make sure that those patients are getting what they want out of participating in a clinical trial?
These initiatives like REMOTE and these different services that are available that help improve convenience, improve engagement, improve sharing and learning with the patient during the study, I think are all in scope, so to speak, and very much consistent with that spirit of becoming more patient-centric as an enterprise.
About the shift from subject to participant: There seems to be more focus in the healthcare side of it on patients. What are your thoughts on that movement?
In thinking about that shift in mindset from subject to participant, I visualize an art class where everybody is staring at a bowl of fruit. That’s the object, the subject in the room that everybody is drawing data and information from. The fruit doesn’t really benefit, right? And we don’t push anything back to the fruit. We just extract data and information from it.
That’s the way a clinical trial participant has been in the past. But going forward, how do we make that a much more enriching and engaging experience for them as well? And what are the benefits to us in the whole clinical research enterprise in doing that in terms of improving recruitment, retention, data quality, speed of conducting trials, and so on?
It’s a very real trend. It’s driven by factors as diverse as the Internet and the proliferation of health information technology. And so the ability for consumers and patients to have access to greater information to be better informed, while at the same time, seeing shifts in terms of payer models and reimbursements and seeing patients having to carry a greater share of their healthcare costs, I think collectively make the patient, it means that the patient needs to become more engaged as a participant in their health. And we need to engage them as a partner.
So I think that we see these trends as very real in healthcare and now, you know, if that patient mindset will be shifting, it is happening now and it’s proliferating, then we need to stay in sync in clinical research. Otherwise to the E-patient of today, who is that active and engaged participant in their health, what are the incentives for them to participate in a clinical research program? They are potentially very small.
In a program where we inherently remove their name, give them a number, give them a drug and don’t even tell them what the drug is, what are the incentives for them to participate, and how do we provide some incentives by making that shift to participant versus subject?
Q. What do you foresee being the biggest challenge in moving forward with a patient-centric clinical trial?
A. There are a number of discreet modules that we are testing and demonstrating in the conduct of this pilot (REMOTE)—our ability to recruit patients online, our ability to screen and consent patients online, our ability to enable patients to have visits take place at home or to ship study drug directly to the patients in their home.
Going forward, in future Pfizer trials, there may be instances that we’re able to put all of these pieces together in this clever way again. Perhaps it’s in areas as diverse as rare diseases, the idea of bringing the trial to the patient, wherever they may be. Or it could be another primary care indication as we’re piloting now. But, for us, it’s also a win to have a portfolio of modules that we can reuse in more conventional brick and mortar studies to make it more accessible for patients.
There are a lot of wins that we can make that are a bit more incremental in terms of the tools that we’re using in our conventional studies. But then we can also look at some clever matchups, if you will, across these different partners to look at ways that can really be transformational in our engagement with those patients.