Is Preventing Dual Enrollment Essential To The Integrity of Clinical Trials?
By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Patient recruitment is an issue in most clinical trials, and continues to get more difficult as protocols become more complicated than ever. While many patients have never heard of a clinical trial or would never consider taking part in one, there is a growing group of individuals out there who rely on them to pay the bills and put food on the table. Unfortunately, these human lab rats have the potential to corrupt your data or possibly even torpedo your entire study.
A recent article in The Atlantic titled The Life of a Professional Guinea Pig illustrates the extent of the problem facing today’s clinical researchers. A community of individuals calling themselves ‘guinea pigs’ or ‘lab rats’ are now making their living participating in clinical trials. Calling themselves professionals, these career participants seek out the most lucrative studies and share with each other all the data they have about new studies that are recruiting. One of the things they also seem to frequently share is the level of dishonesty they believe is sometimes necessary to get enrolled in a study.
For example, most of these professionals know how to correctly answer questions they are asked (yes, they are healthy, no, they have never been sick, no, they have not participated in another trial in the last 30 days) and know what not to do before screenings (no drinking or smoking is a given).
I’m In It For The Money
When determining if a patient is enrolled in another study, or has recently completed one, many sites simply rely on the honesty of the participant. Unfortunately, that honesty is oftentimes called into question. According to one patient quoted in The Atlantic article, “It sounds selfish, but the way it works is, I’m working poor, and the people making the drugs are filthy rich, and I need a job.”
The situation is serious for a sponsor company or CRO, which may have to throw out data or even scrap an entire study if some form of patient deception comes to light. The cost for a sponsor company could reach into the millions.
Verified Clinical Trials is one company attempting to protect studies and their data from dishonest trial participants. By subscribing to a database, researchers can easily ensure subjects are not already enrolled in other studies.
Some Patients Will Lie
Prior to founding Verified Clinical Trials, Kerri Weingard, Chief Operating Officer, and Mitchell Efros, CEO, spent a combined 28 years working in the clinical space for AccuMed Research Associates. During that time, the problems associated with professional clinical patients became obvious to both of them.
During Weingard’s time at AccuMed, the company became a successful and prosperous research center. But that growth came with some eye-opening experiences. She notes her staff would have to repeatedly confront research patients who would inadvertently return the wrong study drug to their site. Sometimes a patient would be simultaneously participating in two studies for the same ailment, but would return medication from the other site, or which contained a different subject number on the drug bottle.
“There were some instances where the patient returned a completely different bottle of medicine,” notes Weingard. “To make matters worse, I often caught subjects verbally confirming their healthy volunteer admission dates on their cell phones while sitting in our waiting room.”
The Search For A Solution
One day while having a conversation about the problems they faced, Efros and Weingard decided something needed to be done regarding the negative impact of multiple study enrollment and washout period violations, as well as the problems they could potentially cause, such as adverse events, anemia, teratogenic effects, and the loss of data quality for the trial.
Weingard and Efros knew that in every protocol, there were a number of exclusion criteria that patients, principal investigators, and clinical research coordinators could positively confirm. For example, the exact date of past participation, half-life of last compound received, and the class of compound received. Given that research centers do not speak to each other, HIPAA restrictions don’t allow the sharing of patient information across sites.
With that knowledge they set out to create Verified Clinical Trials, a de-identified research subject database that would prevent dual enrollment by patients and reduce protocol violations.
“It was clear to us that developing a simple de-identified subject database was a necessary step in the research process,” says Weingard. “It took us about four years but we believe the research industry is finally starting to change. Many CROS, as well as small and large pharmaceutical companies, now have mandates in place to assess the risk of duplicate enrollment in every study. Our focus has been concentrated on the areas of highest abuse, such as healthy volunteers, CNS (central nervous system) studies, and all subjective health conditions.”
According to Efros, the research subject database is used at the study site to ensure potential research subjects are not:
- Currently enrolled in another trial
- Currently in-screening at another research site
- Violating the required number of half-lives since the last research trial
- Violating the washout period between trials
- Violating a biologic modifier, radioactive isotope, vaccine or growth hormone washout period
- Exposed to the same investigational compound if exclusionary per the protocol
- Already a screen failure for the same trial if exclusionary or exposed to a set number of compounds
- Enrolled in a set number of trials in a set period of time.
The database exists at the research site level, where the potential research subject presents for screening. After signing the informed consent, the site staff member enters the subject’s demographic partial identifiers into the proprietary database and the information is run through an algorithm. A de-identified, reproducible, unique identification code, which is connected to the research subject’s study history, is produced.
“The research subject’s study history is compared to the desired protocol’s exclusion criteria listed above,” notes Weingard. “The site staff member will be instantaneously informed if the subject is violating any of the selected protocol criteria within the database’s network. A printable report becomes part of the source document so that any monitor or auditor can view it. Subject information is maintained at the site where they signed consent and commenced the screening process, and only database staff members and staff at that site can view the partial identifiable information.”
Protecting The Trial And Its Data
The database already has fans in the clinical space. Michelle Roach, Director of Operations at research facility Quality Research Inc. notes many sites have received that dreaded call far into a trial, usually from a lab, noting the detection of a possible dual enrollment.
“I have had the more exciting experience of a subject bringing in the wrong diary or study drug,” she states. “I would love it if this process became industry standard. In our current trial, the database allowed us to identify two subjects who were not yet eligible for participation. We were able to reschedule the subjects to allow them to both participate and properly meet the protocol requirements.”
Thus far, metrics obtained by Efros have exceeded his expectations. “The industry has gone from having no patient database, to having one where sponsors and CROs can look for violations across all phases of a study and all disease entities,” he says. “Sponsors and CROs can now see protocol violation prevention rates in most studies ranging anywhere from 4 percent to 20 percent. Tracking the patients participating in your study is now necessary to improve patient safety and maintain the quality of data obtained from the study. That is a safety protection net for companies and will result in significant cost savings for the entire industry.”