Can virtual clinical trials succeed?
Are we to conclude that the virtual clinical trial model is a failure? My answer (spoiler alert) is a resounding no. Read on, and I will explain.
We tend to think of the traditional brick-and-mortar clinical research model as a hindrance to patient recruitment. Because research participants must travel to a research site, our participant pool is limited to people within a reasonable distance from a site. And for those within a reasonable distance, participation poses the inconvenience of regular site visits.
A virtual trial removes these barriers, so theoretically it should improve, rather than discourage, clinical trials participation. Unfortunately, this theory has not proven true for Pfizer. Why?
The Role of Trust and Relationships in Trial Participation
In July of 2011, I wrote a blog post titled “Pfizer’s At-Home Clinical Trial and a Lingering Question.” As the title indicates, this post described a lingering question I had about the viability of Pfizer’s virtual clinical trial model.
I speculated that perhaps the act of visiting a research site, though inconvenient, actually serves to encourage research participation and retention. The relationships between site staff and volunteers play a critical role in trial participation. And these relationships are developed due to interaction that participants have with research staff.
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.
(Read the full post, including the research I cite, here.)
Though the traditional clinical trial model has limitations, it may be serving an extremely important function. And this function is to build trust and facilitate relationships, in turn bolstering patient recruitment and retention.
Trust and relationships are critical given public attitudes about healthcare information and clinical trial participation.
Public Attitudes as Barriers to Clinical Trial Participation
A 2009 HIMSS survey found that nearly 4 in 10 consumers (38 percent) are still very concerned about the privacy and security of personal health information.
Meanwhile, a survey by CISCRP reported that 74% of respondents “say they have no ‘real’ knowledge of the clinical research process.” Lack of awareness is exacerbated by misconceptions about clinical research, which continue to be perpetuated by the news media.
These public attitudes pose a challenge to patient recruitment in all clinical research settings. Many patients never even consider clinical trial participation, much less take the step of contacting a research site for more information.
However, once clinical trial participation becomes a consideration, the availability of a research site can go a long way in overcoming harmful attitudes about participation. With a virtual clinical trial, patients do not have the same interaction with research staff, which can leave patients feeling distrustful and disengaged.
Does this reality mean virtual clinical trials are doomed?
Facilitating Patient Trust and Relationships with Technology
No. But virtual trials must build trust and relationships in new ways.
Technology can facilitate trust and relationships. But it's not always easy.
But long before I used digital media in the context of patient recruitment, I used it personally. Social media, in particular, has allowed me to develop relationships with wonderful people. And the virtual world has engaged me in communities that would not have otherwise been accessible.
So, in my experience, it is possible to create trust and facilitate relationships virtually. That’s not to say that it’s easy.
The Big Challenge (and Trend) in Technology
In a face-to-face environment, the process of building trust and relationships tends to occur naturally. We are hard-wired for it. And in-person interaction is a skill we’ve practiced our entire lives.
In a virtual environment, on the other hand, this process must be far more deliberate. To earn trust, you need a great understanding of the digital ecosystem and the mindset of people navigating that ecosystem. Even those with an excellent grasp on the social aspects of technology have plenty to learn in this area.
Our understanding of the social psychology of technology is in its infancy. For a long time, technologists had little interest in creating technology that conformed to human nature. Instead, many technologists expected human nature to conform to technology. Thankfully, that attitude is shifting.
The growing realization within the tech industry is that technology must be strongly informed by the behavioral and social sciences. The popularity of social media, for instance, has illustrated how powerful technology can be when it facilitates human connection.
The Future of Virtual Clinical Trials
Ultimately, technology needs to make patients feel more connected rather than less connected to the clinical research process.
In my July 2011 post on virtual clinical trials, my lingering question was this:
Is the at-home clinical trial technology implemented in a manner that facilitates these important relationships between participants and study staff?
From what I’ve read about Pfizer’s virtual clinical trial, the answer appears to be no. My view then, which has not really changed, was that facilitation of these relationships would be a challenge but not impossible.
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.
Virtual trials that use technology to build trust and facilitate relationships will have the best chance of success. What a future virtual model will ultimately look like, I can’t say. The possibilities are endless.
One of Many Possibilities
For example, I can envision a future virtual trial model in which patients have less of a relationship with research staff but more of a relationship with each other. Such a model would allow us to create efficiencies while ensuring that participants remain connected to the research process.
Obviously, such a model could introduce all sorts of potential operational and regulatory difficulties. And we are a long way from being able to fully overcome these difficulties. But I think it’s possible. And in the shorter term, technology can be implemented in a manner that facilitates participant connection without contact.
Regardless of the outcome, development of a good virtual trial model is sure to be an evolutionary process.
Clinical Trial Innovation Requires Iteration
True innovation pushes boundaries and challenges our existing mental models. For this reason, true innovation is not successful on the first attempt. It requires iteration and experimentation to arrive at what most people would deem a “success.”
Roadblocks on the first iteration cannot be viewed as a failure. These roadblocks are merely areas to improve on the second iteration. This process is the nature of innovation.
Pfizer’s virtual trial is truly innovative. It pushes boundaries. It challenges our mental model of what a clinical trial should be like. So I am not the least bit surprised that Pfizer encountered some challenges on its first attempt at a virtual clinical trial.
And I have no doubt that the people at Pfizer will use these challenges to inform improvements on the second iteration. According to Outsourcing Pharma, they already have.
In response to these realisations Pfizer has revamped the model. A call centre now helps patients through the initial steps and Pfizer is receiving feedback from participants to help shape its plans for the virtual trial model.
Since making the changes Pfizer has seen an “immense inflow of subjects”, Orri said, but the delay means it is behind on its goal of recruiting 600 patients in the US.
My personal view is that call centers are not the most patient-centric of solutions, but this change is certainly an improvement over Pfizer’s original model. And it’s producing results.
Regardless of how Pfizer’s virtual trial model evolves, the process will be exciting to witness. And the team behind the virtual trial should be congratulated on their willingness to pioneer this model.
What do you think? How do you feel about virtual clinical trials? How can Pfizer’s virtual trial model be improved? Share your thoughts in the comments.
Great post, Rahlyn. My thoughts are that Pfizer approached this digital initiative with the hopes that digital media could self-recruit. They learned the hard way that this medium hasn’t achieved critical mass. Moreover, I fear they may be focusing on recruitment without thinking about retention. Thankfully, you noted that they are surveying current study volunteers to improve their process. Let’s hope they are asking the right questions that not short-sighted. Ideally, rather than re-make the wheel, it be prudent if Pfizer reached out to patient recruitment experts who could save them time and effort in honing their strategy. Alas, recruitment and retention are the after-thoughts in the clinical research equation to pharma’s peril.
Hi Carmen,
Thanks for stopping by to share your expertise! As you point out, digital media most certainly does not “self-recruit.” Nothing can fulfill that sort of promise.
Digital media has a lot of potential, and it’s been used to successfully recruit for many other studies. Part of the challenge, in my view, is that many in clinical research expect to be able to apply existing patient recruitment processes to these new mediums. But digital media requires vastly different skills, strategy, and implementation. And I think that will become even more evident as things evolve.
I was just reading this article from a sociologist who believes that, in some ways, technology is making us more social.
http://www.smithsonianmag.com/science-nature/How-Technology-Makes-Us-Better-Social-Beings.html
As the article points out, we tend to think of interaction with technology as a loner behavior. But the reality is that most people are using technology to connect with others. And I think people tend to gravitate toward technology that allows them to be more connected.
Assuming this sociologist is on the right track, I think that’s support for the argument that virtual trials need to be implemented in a way that facilitates connection.
Yet another great and insightful post Rahlyn! Your thoughts made me think of several things, like: The early days of TV and how Walter Cronkite gained the trust and confidence of America as the ‘face’ (remote) of trustworthy reporting. With exposure (which tells a story BTW), people come to feel comfortable and familiar with celebrities they’ve never met- or uncomfortable. Maybe we ought to think more about establishing an identifiable person with a trial. Maybe there are ways to accomplish the same thing without a real person. We come to know and trust cartoon characters (personifications of real people), right?
What about the demographic of the patient population and how that may influence recruitment and retention presentation approaches with media?
I agree that connections without F2F contact opens tremendous possibilities. And you’re right, we’d be foolish to stop now because of a hiccup.
Still the critical contributions study site staff can make come to mind especially when a project doesn’t readily fit this new model. A creative mix of old and new is easy to imagine.
It would also help here if we would stop talking about how to ‘drive’ study sites, and focus more on productive exploration of new ideas with our centers.
Keep the ideas and conversation coming!
Thanks, Greg! That’s a great example about Walter Cronkite. I’d love to see more experimentation in some of the ways that you describe. For the most part, we tend to devote resources to patient recruitment on an as needed basis. But I think both patients and the industry would benefit from more long-term industry investment in patient education and awareness.
I completely agree about the “creative mix of old and new.” I think that’s most likely what we’ll see in the near term. Pfizer implemented this product in a modular way. So I expect that they will be able to use the various modules they’ve developed to improve the traditional clinical trial model as well.