After more than a decade in the business of detecting “professional research subjects,” Verified Clinical Trials is a familiar name to stakeholders across the research enterprise—including the nefarious players who ride-share from city to city in search of unprotected sites where they can enroll in studies purely for the financial gain. It’s an underappreciated underground economy that is costing sponsor companies time and money and, in some cases, completely shutting down studies, according to Mitchell Efros, M.D. FACS, CEO of Verified Clinical Trials.
Before he and COO Kerri Weingard founded the company in 2009, they ran a research site together, Efros says. They could never be sure if they had enrolled subjects who were simultaneously participating in another study or had yet to complete the required washout period or were unknowingly violating the study protocol in multiple other ways. So, they decided to introduce a new step to the research process at the time of screening to correct the problem.
Verified Clinical Trials uses both ID-metric and optional biometric fingerprint technology to register subjects, originally to identify.
in phase 1 trials, says Efros. The system today is used globally across all phases of clinical research and almost all therapeutic indications and considered a “must-have” due to a confluence of factors: the pandemic causing people to lose their job and health insurance, a culture of dishonesty, increasing use of social media to recruit subjects, stringent patient privacy laws banning the collection of individuals’ full date of birth and initials, and the inherent cheating risks associated with decentralized and hybrid model trials where participants have little or no physical contact with a research center.
This means the bulk of professional patients, the biggest group of offenders, are flocking to sites and studies that are not using Verified Clinical Trials, he notes. And they know because they share the intel with one another online and actively avoid traveling to sites where they know they are going to get caught.
The company verifies identities and past research history, with or without biometrics, in over 50 countries and across entire study portfolios of various pharmaceutical companies and CROs says Efros. “There is never a trial where we don’t detect multiple issues and prevent [protocol violations]. Once a company uses us, it is a client forever.”
Market penetration isn’t at 100% just yet, but the network has been “exponentially” growing and the effect has been to strengthen the overall research community, Efros says. For study sponsors, preventing the wrongful enrollment of just a few subjects could pay for the service given the expense of screening and enrolling each participant. Even the NIH uses Verified Clinical Trials.
And that is before factoring in subject compensation for time and travel—a figure that can run anywhere from hundreds or thousands of dollars per subject for a phase 3 trial involving multiple site visits to tens of thousands of dollars for a particularly lengthy or risky phase 1 study involving an inpatient stay, says Efros. Therein lies the enticement to become a professional patient.
An individual making multiple site visits per day can make a good living, usually tax-free. “That is the way they survive,” he says.
The problem of professional and duplicate subjects has existed for as long as there have been clinical trials, but it has grown increasingly acute with the rise of social media advertising campaigns, tight study recruitment timelines, and the fact that subjects almost always get some sort of compensation for participating, Efros says. Heightened socioeconomic issues around the world over the past few years have only exacerbated the situation.
Surprisingly, the culprits are not all young, he adds. In fact, the phenomenon “spans all age groups, all ethnicities, and all geographic regions. We have looked at that data.”
While many of the violations Verified Clinical Trials prevent happen within a limited geographic region, professional patients will routinely travel 25, 50, even thousands of miles hopping study to study, says Efros. And this is just the “tip of the iceberg,” he suspects, since not all sites and sponsors are currently checking for the problem. “They don’t know what they don’t know.”
Culprits include individuals who qualify for a study but enroll in multiple trials at the same time for the compensation, those who have the required heath condition but are in it for the drugs, and those who falsify information right from the start purely for financial gain. “The truly professional subject who is doing it just for money may not even take the investigational product,” says Efros. When subjects tell study site coordinators what they want to hear instead of the truth to remain in a trial, it can skew the results and raise the placebo response.
Quite frequently, these patients will go into the same study at multiple study sites. They learn from each other, or their screen fail at another site, how to game the system by answering the screening questions so they appear qualified, he says.
Less commonly but no less harmful are people who double-enroll in clinical trials because it is their only care option. They might be in a diabetes trial at one site and a high blood pressure study in another, and perhaps also an anxiety disorder trial at a third location, says Efros. “They are mixing and matching investigational products, which may not be safe.”
Then there are those who don’t understand the prohibition against dual enrollment is meant to safeguard their health (e.g., potential damage to their liver, heart, or medical condition) as well as the integrity of the trial. The study may fail to meet its endpoints due to unknown drug-to-drug interactions.
Broad And Deep
Wearable technology has been proposed as a potential, if future, way to address the professional patient problem but that is totally unrealistic and could never match the data points (study drug and dates of enrollment across multiple therapeutic indications) collected by Verified Clinical Trials, Efros says. “Many studies don’t use wearables; it is very limited in scope and there are financial constraints.” Verified Clinical Trials also detects these issues at the time screening, “way before other modalities, thereby saving [companies] time and money.”
Moreover, a global team of legal and regulatory experts has enabled Verified Clinical Trials to operate in Europe and other regions of the world with the strictest of privacy laws, he adds. “There is no country or region where we cannot operate.
“Ultimately, without a registry or a tool like Verified Clinical Trials, there is no way to know whether subjects are currently enrolled in a trial or are in the washout period,” continues Efros. A handful of other companies do similar work but on a “very limited scope and scale… no other registry or solution is as large and comprehensive… covers phase 1 through phase 4 and… is global.”
Neither do any of the other registries cover phase 1 studies with more than limited coverage, if at all, he adds, and “they have no phase 2 and phase 3 coverage.” High market penetration is why the National Institutes of Health is on the company’s client list.
Verified Clinical Trials is also the only system able to accommodate decentralized clinical trials, Efros says. In fact, growth over the past few years has been partly driven by business deals with companies specializing in this area.
The optional biometrics capabilities of Verified Clinical Trials, which is soon to expand to include facial recognition capabilities, are also in comprehensive use across study phases, says Efros. “Whether a study is built to have biometric capture [of duplicates] or not… it works the same.”
Biometric capabilities are particularly popular for phase 1 studies, notably in the U.S., to reduce the time it takes to complete the verification process. Among some larger pharma companies, biometrics still have a stigma because they don’t understand Verified Clinical Trials is not capturing and storing fingerprints but creating proprietary, privacy-protecting templates based on fingerprint scans to match patients to their old records, he explains.
Importantly, Verified Clinical Trials helps prevent 20 protocol violations, including enrollment of individuals who have not completed their mandatory washout period. For vaccine trials, the required wait may be three to six months, Efros says. “Some sponsors have professional subjects doing more than three or four studies a year and they may not be the best subjects.”
Those pros may be completely unsuitable for a study where subjects need to be completely naïve to a vaccine or compound, most especially radiopharmaceuticals, he adds. “We can follow a compound from phase 1 through phase 4, so sponsors would know if subjects had ever been exposed.
Verified Clinical Trials can also identify individuals who were a screen fail in the same study at a different site, which is a commonplace exclusion criterion, says Efros. Likewise, the system can detect exclusionary health conditions, such as a diagnosis of schizophrenia for a depression trial, based on individuals’ clinical research history.
If an alternative solution is being used many problems are completely missed and, at best, don’t get uncovered until after the subject has been screened and randomized, Efros says. “The beauty of what we do is to determine these issues—duplicate subjects, professional subjects, and these other protocol violations—before subjects are in the study and then those protections continue the entire duration [of the trial].”
Should any enrolled study subjects decide to drop out and attempt to get into a different study, the system would catch them in the act. This across-the-board detection method serves to improve the integrity of studies, reduce the placebo response, and safeguard subject safety. It may well also prevent a company from having to repeat a trial or shelve a once-promising product.
Part of these efforts involves working with companies conducting online patient recruitment campaigns, he says. All too often, they’re “tripping over each other… recruiting the same subjects.” Verified Clinical Trials can do a pre-screen to solve that issue.
Facial recognition technology about to roll out will allow biometric verification without the need for a physical scanner, says Efros. The identity check can be performed on any computer, tablet, or smartphone, with patients screening for decentralized clinical trials able to do self-verification remotely.