When Pfizer announced that it was conducting the first at-home clinical trial under an IND, I was initially skeptical, particularly with regard to issues of consent and safety. But over the last few weeks Craig Lipset of Pfizer has done an excellent job of answering questions in a variety of venues, effectively demonstrating the thoughtfulness of his approach to this project’s implementation.
Pfizer is conducting the first at-home clinical trial under an IND.
Craig took the time to respond to questions in the comments section of Pharmalot‘s article on the subject, in addition to answering questions in a pharma social media chat on Twitter. Most recently, Craig responded to questions from Dan and Don of Clinical Trials Guru during an excellent interview.
But I still have one lingering question about the “trial in a box” concept that I have yet to see discussed.
In theory the at-home clinical trial model could improve recruitment and retention by opening up trials to a larger patient population and making trial participation more convenient. However, this approach may present substantial challenges for recruitment and retention as well.
Though the time commitment required for clinical trial participation is substantial, I’m not convinced that this commitment is as much of a deterrent as is often believed. In fact, the act of going to a study site and interacting with study staff may be a key component of good recruitment and retention.
The Role of Site Staff
Kenneth Getz of CISCRP did a focus group with study volunteers to learn about their experiences and perceptions of clinical trials.
Study volunteers readily and consistently affirm the essential role that study staff and health care professionals play in volunteer recruitment and retention. These professionals are the sole interface and the primary vehicle through which volunteers learn to trust, interact, and comply with clinical research…
Volunteers’ personal relationships with study staff greatly influence the decision to initiate and the willingness to complete participation. The overwhelming majority of conversation group participants praise the support system offered by the PI, coordinators, and administrative staff. For some, seemingly trivial actions—like a friendly face, a listening ear, and a level of concern that might have been lacking in their previous medical encounters—go far in engendering trust and the sense that volunteers are valued members of the research team.
My personal experience as a clinical research coordinator is consistent with the attitudes expressed by patients who participated in this focus group.
Relationships with site staff are important to research participants.
Though research sites are charged with the task of protocol implementation, site staff are far more than mere protocol automatons. They offer a support system, build volunteer trust, and help volunteers understand the value of their participation. And these contributions are an essential part of clinical research, as well as a key element of recruitment and retention.
In essence, the relationships between site staff and volunteers play a critical role in trial participation.
Can an At-Home Trials Facilitate Relationships?
So here’s my lingering question: Is the at-home clinical trial technology implemented in a manner that facilitates these important relationships between participants and study staff?
Though true face-to-face interaction can be a challenge to replicate with technology, I don’t buy the notion that interaction with technology need be cold and dehumanizing. It certainly can be, but it doesn’t have to be.
For example, I’ve had very enriching experiences with Twitter and other social media sites, which allowed me to develop meaningful relationships with people who I would not have otherwise met. But these are social media sites, so they are inherently, well, social.
A technology platform designed to deliver at-home clinical trials is not going to be naturally social in the way that social media sites are, so it will not be a platform conducive to building relationships. That is, unless social elements are carefully woven into the technology, allowing participants to experience the same human connection they get at a brick-and-mortar research site. Such an implementation seems like a challenging, though not impossible proposition.
New Clinical Trials Possibilities
I have much respect for the innovation being demonstrated by Craig Lipset and Pfizer. This industry is in dire need of fresh thinking, and it takes courage to take the risk, particularly in the face of common industry conservatism.
"Only those who will risk going too far can possibly find out how far one can go." -T.S. Eliot
Several details of the “trial in a box” implementation are impressive, but one design decision is particularly wise. The platform for conducting these at-home clinical trials was developed as a series of modules. So regardless of whether this particular model is successful, Pfizer will have these modules which it can “plug in” to clinical trials as appropriate.
For example, Pfizer’s informed consent module can be used in other clinical trials to improve the informed consent process. Certainly, particular types of trials may not lend themselves to a virtual consenting process. But that’s the wisdom in this modular format. You only use the modules when they are appropriate for a particular trial.
Whatever the outcome of this at-home trial, the technology developed to support it will be a game-changer for the industry.
Thoughts? Don’t be shy. Put your input in the comments below.
Rahlyn,
Thanks for your thoughtful assessment.
I agree with your comments — staff at the investigator site play an important role in engaging and informing research participants, important drivers of protocol compliance and study retention.
Unfortunately we know that clinical research does not reach all patients who may be interested in participation. The ability to use new tools to reach patients who may otherwise not be engaged is a great opportunity.
Focus groups of research volunteers who have participated in conventional trials should acknowledge the importance of relationships with site staff. But these individuals were engaged to participate and receptive to the commitment of a conventional “brick-and-mortar” study. These patients
are certainly special and unique — the Medical Heroes that CISCRP appropriately
celebrates.
We can now engage patients on their terms. For some that may be a conventional investigator site with in-person interactions and relationship building. For those who prefer convenience and are comfortable building a relationship with an investigator and study staff by phone and over the web, we now have a way for these patients to participate as well. And to become Medical Heroes.
Best,
Craig
@craiglipset:disqus
Craig,
Thanks for your comment. I can definitively appreciate the potential for
the “trial in a box” model to provide clinical trials access to
patients who might otherwise have none. That’s a huge benefit of the
model you and your team have developed.
I do believe that patient relationships developed over the phone and
Internet can mimic real-life interactions, but I think these
relationships require more concerted, careful attention that
face-to-face interaction.
I’m looking forward to following the progress of this project, and I appreciate you taking the time to provide your input here.
Rahlyn
Thoughtful article, as usual. I’m glad you’re maintaining an open mind about the ability of this study model to forge a strong relationship with the patients. I agree that this is a key challenge.
As a provider of mobile phone technologies, this study model is particularly interesting to our company. I believe that the mobile phone can be a key touchpoint to strengthen the relationship between the patient and the study staff. While the Pfizer study is using mobile phone technologies, it doesn’t seem that they are specifically attempting to address this opportunity.
By the way, Craig Lipset deserves a lot of credit for his leadership on this study. Miguel Orri is also involved on a day-to-day basis and also deserves credit.
Jeff Lee
Hi Jeff,
It’s always good to see you here and get your input. I completely agree about the mobile phone as a key touchpoint to strengthen patient and study staff relationships. And the great thing about mobile is that it can be used to improve these relationships in both virtual and brick-and-mortar trials.
I share your appreciation for Craig’s leadership. I can’t imagine the number of hurdles, both expected and unexpected, that needed to be cleared before making this trial a reality.
Rahlyn and Craig
It’s great to see this commentary and hear the attributes of
both the “trial in a box” and “bricks and mortar” trial methodologies being
discussed in such a positive manner.
At Exco InTouch, we have experience of both practices,
specifically providing mobile technologies in support of this Pfizer at-home
initiative and many more times in using mobile technology within the
traditional trial process involving sites.
The interesting aspect that we see time and again in the
traditional setting is that the messages delivered to the cell phone of the
patient are perceived by the patient to be an extension of the support received
in person from the site. Further, the messages are often identified as being
sent from a particular site name or even from the study nurses themselves which
we have seen many times improve retention and compliance within the study. The
patients are glad of this extended support beyond the clinic.
To Craig’s point, the ground-breaking Pfizer study attracts
a ‘new’ set of participants who are more amenable to interaction with
technology. It is therefore unsurprising that messages delivered and data
collected using a cell phone within this study is proving to be successful.
Whether it’s in a traditional ‘site to patient’ study
setting or a ‘direct to patient’ approach, the use of ubiquitous mobile
technologies such as the cell phones enables better engagement with the patient
whether it be as an electronic ‘tap on the
shoulder’ reminder message to collect Patient
Reported Outcomes directly from the phone itself.
In an era where ‘patient centricity’ is becoming a crucial
aspect of most clinical trials we are seeing greater and greater adoption of
these types of technologies to improve the experience for both the site and the
patient.RegardsChris Watson
Chris,
I appreciate you taking the time to share your experience with conducting
this study. And I completely agree about the potential of mobile to
personalize the study experience for research participants. People
(often literally) keep their phones attached to their hip, and they are
accustomed to using it as tool to facilitate real-life relationships.
Text message open/read rates are generally over 90%, which I find to be
just incredible. No other form of media comes close to that kind of
access. I do wonder, however, if this rate will continue to be as
impressive once mobile marketing becomes more prevalent. I opened much
more email, say, 10 years ago than I do today because I received fewer
of them and the signal to noise ratio was better.
I think it’s important to remember that people amenable to technology
aren’t any less interested in having a human connection. In fact, I’d
argue that it’s that basic need that has made social media such a force.
So I’m pleased to hear you guys are personalizing the study experience
by sending messages identified as coming directly from the study site or
nurse. I think these kinds of implementation details are important.
This is a very interesting time in the industry, and I’m excited to see
how technology adoption improves clinical trials processes, ultimately
benefiting patients and research professionals alike. Certainly,
missteps are inevitable as we learn, but the long-term possibilities are
exciting.