Online patient recruitment: Still nascent after all these years
The world of online patient recruitment has undergone an evolution since it arrived during the heady dot-com craze of the 1990s—but has that caused a revolution, one that has transformed the space?
Most say no, not yet. But it may be on its way to doing so.
It all began when the internet surged in the late 1990s: a slew of companies—largely private equity and venture-backed—formed to leverage the reach of the Internet to improve patient recruitment effectiveness.
During the dot-com craze, market entry and access to capital were easy, and numerous companies entered, including Acurian, America’s Doctor, Clinicure.com, Drkoop.com,
EmergingMed and Veritas Medicine to name but a few. Many of these companies did not survive when the dot-com bubble burst. Others had to modify their business models dramatically in order to survive and to remain viable.
Awareness and enrollment
What happened? What went wrong?
For one, the early business model for online recruiting companies didn’t work, explained Ken Getz, director of sponsored research programs at Tufts Center for the Study of Drug Development (CSDD), chairman of the Center for Information and Study on Clinical Research Participation (CISCRP). Getz is also the founder of CenterWatch, which was, in the mid-1990s, the first website to publish active industry-funded clinical trials categorized by disease for patients to identify opportunities to participate.
“The first generation Internet recruitment companies weren’t positioned properly,” said Getz. “They only promoted clinical trials paying for patients and the payment model was predicated on an enrolled patient—with no upfront fee required,” he explained. “A lot of sponsor companies liked the low-risk approach, but the Internet companies could not deliver sufficient enrollment performance to cover shareholder and investor requirements.”
That’s because looking for patients on the Internet—either by intercepting them in diseased-based communities or running ads in the places they visit—resulted in “filling the top of the funnel with interested parties, but then not many of them sifted down to the bottom of the funnel to actual recruitment,” said Hugo Stephenson, executive chairman of DrugDev, founder of iGuard, later named MediGuard, an online recruitment tool that was bought by Quintiles. Stephenson has now also returned to being a principal investigator in Australia.
“Years ago, the perception was that the true answer lay in simply getting the message to patients that trials were out there, and the belief was that most people would consider being in a clinical trial if they’d only heard of them,” said Stephenson. “The Holy Grail was thought to be awareness, but that didn’t turn out to be the case.”
Instead, it was much more complicated than that. If a patient or their caregiver is highly motivated—envision a cancer patient with no other options or the parent of an autistic child where there is unmet need—yes, they will move mountains to enter a trial once they learn about it. But the rest of the population? Not so much, said Stephenson. And even less so if the trial is inconvenient or not particularly patient-friendly, which is even more common these days as trials have gotten more complicated. Also, the patients who are willing to be in a trial may not be the ones a study is actually looking for.
And the early online companies may have been good at aggregating useful information on trials in one or two therapeutic areas and matching potential patients against inclusion/exclusion criteria, but were unable to come up with algorithms for doing that across all trials in all areas.
All of this, said Getz, squashed the early dream of easy online recruiting.
Better data crunching
The dream, however, is still alive; it just looks a bit different in an online world defined by social media and sophisticated assessment of individual behavior.
Enter Antidote. Launched in 2010 as TrialReach, Antidote is in the process of building a meta search engine for clinical trials with a free side for patients and a pay side for sponsors and CROs. The model is not new, but this time the company believes it has more firepower; Antidote’s co-founder and CEO is Pablo Graiver, previously VP of business development in Europe at the travel meta search engine Kayak. And this time, the effort has 83 people sitting in a room perpetually trying to restructure voluminous inclusion/exclusion criteria for every clinical trial out there in an effort to make it easily searchable.
“No one had before tackled the fundamental problem at scale for all disease areas, and that’s important now as medicine is getting more refined,” said Sarah Kerruish, Antidote’s chief strategy and growth officer areas. “Restructured protocols are matchable protocols.”
Antidote partners with health portals including Healthline, Everyday Health and CenterWatch, as well as patient networks like WEGO Health and CureClick and disease groups communities like JDRF. Antidote also said it’s working with the World Health Organization, and “half of the top 20 pharmaceutical companies.”
Others—Clairiness, Inspire, PatientsLikeMe, Health Unlocked and Quintiles’ digital effort—are using a similar model with some success. Regardless, these companies have one central problem that will keep them from revolutionizing the field, said David Kronfeld, senior director of corporate development at Medidata Solutions.
“The fundamental flaw with online patient recruiting is that it depends on patients to explore treatment alternatives beyond the recommendations of their physicians,” he said. “True, patients are increasingly taking an active role in their care so it seems plausible to engage patients online where they seek information. However, this is unlikely to scale.”
EHR a game changer?
Kronfeld and others who closely watch the space say the real future of web-enabled recruiting lies in the mining of electronic health records (EHR).
Enter, ePatientFinder: This two-year-old, venture-backed Texas company’s model involves partnering with EHR companies to pinpoint patient data and enroll protocol-eligible patients. The concept involves “geo-precise heat maps” of specific regions showing exactly where the patients are, exactly who their doctor is and then “harnessing the power of the trusted physician-patient relationship in a consult setting.”
“There are tens of thousands of clinical trials running at any given moment—it’s impossible for a primary care physician to keep up with them,” said Tom Dorsett, founder, president and CEO of ePatientFinder. “We educate them on trial opportunities, then help them identify specific patients. Patients say they like getting a call from their trusted physician who has sought out a trial opportunity for their chronic condition.”
Does it work? ePatientFinder claims it does. According to their numbers, of the patients contacted, 85% say they’re interested in the trial, and of the referrals sent to trial sites, 78% are accepted into the trial.
Still, it’s very early days for this EMR-mining concept, which is a complicated one.
Dave Comen, chief strategy and marketing officer at ERT, formerly SVP head of health engagement and communications, chief marketing and communications officer at Quintiles (Digital), said, “EMR mining is very nascent at this point. There’s an accessibility issue; the data you get out isn’t necessarily the data that you’re requesting. And the other issue with this approach is competition: Does the physician really want to refer his or her patient away and into a trial? Sometimes not. You’d like to hope that wouldn’t be the case, but in many times, it is.”
Then there is the issue of privacy, said Alan S. Louie, research director of life science R&D strategy and technology at IDC Health Insights. “The fundamental thing that has held back the use of EHR is access to a sufficient pool of patients while maintaining HIPAA compliance,” he said.
Nevertheless, much of the online recruiting world is headed in the same direction as ePatientFinder, exploring ways to fruitfully drill into EMR to find patients, then ask physicians to refer patients into trials. That includes Antidote, which said it will launch just such an effort this year.
360 Approach needed
Other thinkers in this space say a true revolution will take a far more widespread approach than that. Many point to companies like Acurion and BBK, recruitment companies that tailor their approach to each trial, using some high touch components for some, and more automated approaches for others, acknowledging that no drag-and-drop solution could ever work in the world of patient recruitment.
But still others say we now have the various tools to revolutionize patient recruitment—with online efforts being a large part of that—but that the key lies in fitting them all together just so in the perfect ecosystem, and that has yet to happen.
“Much like a puzzle, all the pieces are there, but the solution is only apparent when they are assembled correctly,” Medidata’s Kronfeld said. “Doing so will likely require development of an ecosystem of data, analytics, technology, services and provider organizations, at a minimum. There is still a long road ahead, but we can see the pavers being laid. What is less clear is how to integrate these data-driven insights into the workflows of physicians in a low-friction way. There is some innovation on this front as well, but none that is large scale yet.”
As time has gone on, people have realized there isn’t one single answer that will solve the patient recruitment problem. “It will have to be many things that need to be put in place to get a 360 view of the patient,” he said.
And woe be to those efforts that undermine the role of the physician and the individual patient’s community of care, said Getz.
“It’s clear that recruiting efforts have to be undertaken in concert with the patient’s physician and community of care,” he said. “That relationship is absolutely essential. Anything that moves away from these relationships and fails to integrate runs the risk of not adequately reaching or keeping the patient.”
Getz said he’s already seeing some early signs that the industry understands that, including the marrying of investigative sites with large health systems. In doing so, study staff can more easily move back and forth between the two environments.
“The integration of patient recruitment and retention into the continuum of care is very early stage, but there are numerous signs that the clinical research enterprise must go in this direction to remain viable,” said Getz.
Suz Redfearn is an award-winning journalist and former senior staff writer for ClinPage.com. Her articles have appeared in numerous publications, including the Atlantic.com, the Washington Post, Slate, Salon, Politico, Men’s Health, MedPage Today and Physicians Practice. Suz holds a degree in print journalism from Loyola University in New Orleans and has been a medical writer since 1990, focusing on clinical research since 2007. Email firstname.lastname@example.org.
This article was reprinted from Volume 24, Issue 01, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>