Clinical Researcher—April 2021 (Volume 35, Issue 3)
RECRUITMENT & RETENTION
COVID-19 is a force that has affected virtually everyone in one way or another. Most of us have gotten used to wearing masks outside our homes, using sanitizers regularly, practicing social distancing, avoiding large gatherings, and washing our hands regularly. The novel virus has also pushed a lot of topics to the forefront, such as telehealth, remote work, and clinical trials.
Clinical trials used to be a niche topic that was discussed primarily among healthcare professionals and stakeholders working for contract research organizations (CROs), study sites, patient advocacy organizations, and pharmaceutical companies. However, the pandemic made it a household topic. “Which pharmaceutical company will come up with THE vaccine?” “Which trial is in which phase?” “How long will it take for a trial to provide a safe vaccine?” Everyone was asking these questions.
While only a handful of vaccines received emergency use authorization (EUA) after thorough testing (with Johnson & Johnson’s being the latest one), there are numerous vaccines that didn’t see the light of day. When it comes to clinical trial failures, most researchers would list the lack of efficacy, data inconsistencies, safety issues, lack of funding, or protocol errors as primary reasons; however, there is another factor that often flies under the radar but causes major issues—the challenge of dealing with “professional patients” in clinical trials.
What are professional patients and how do they hamper the integrity and efficacy of clinical trials? To understand that, let’s take a look at how clinical trials have been impacting our lives and preventing diseases in the process.
Clinical Trials in a Nutshell
Clinical trials are nothing new; many pharmaceutical companies (with help from CROs and study sites) and independent investigators have been conducting drug and medical device studies with human subjects for decades. The typical goals of such trials are quite simple—improving health, curing deadly diseases, or reducing recovery times. In fact, many clinical trials result in therapeutic breakthroughs that can effectively treat what were previously untreatable conditions.
However, clinical trials are far more difficult and complex than they usually appear to outsiders. Such studies can cost billions of dollars, take an average of around 34 months to complete for a product that makes it to market, require numerous regulatory approvals across multiple phases, and include patients that need to voluntarily enroll in and comply with what are often complicated protocols—something that can heavily influence the reliability of the data and the efficacy of trials.
Patient recruitment poses a significant challenge for any given clinical trial. Finding patients with the specific conditions required, diversifying the sample, providing them with ample motivation, and ensuring retention until the end of the study are challenges themselves. Vetting patients effectively before enrolling them is another crucial component. However, despite best efforts to weed out potentially bad apples, many professional patients still make it through the process and have the potential to cause billions in losses.
What are Professional Patients?
Also known as “duplicate subjects,” professional patients are individuals who frequently participate in clinical trials for nefarious reasons. Some even participate in multiple studies simultaneously—yes, it happens all too often! Let’s take a closer look at the most common types of professional patients.
The first type of professional patient participates in clinical trials just for the financial compensation. While these patients do check the box of being “healthy” or having the required medical conditions (depending on the inclusion/exclusion criteria of different phases and types of studies), getting paid to participate leads them to sign up for multiple studies—either subsequently or simultaneously. These patients may receive several doses of drugs from different trials in very short timespans that not only affect their health, but can severely impact the trial or study data through drug-drug interactions. While one or more of the drugs may have been promising, overall results can be skewed by patients who fail to display the expected benefits due to drug effects from other trials in which they are secretly involved. This can lead to costly repeats of trials.
The second type of professional patient is far more dangerous. While they do have the required health conditions, they are in it for the drugs. This can be commonly seen in research regarding addiction treatment and drug abuse. How exactly do these professional patients hamper research data? Well, they fake the results during trials in hopes of upping the dosage and gaining access to more drugs. Once again, this can lead to data quality issues, causing effective drugs to be announced as failures.
The third type of professional patient is one who falsifies his/her information right from the start, purely for financial gain. They don’t have the required condition(s), but use different strategies to participate in trials—and some of them even get enrolled! In these cases, testing data are manipulated from day one and, during the trials, the data quality will worsen even more as these patients never had the required conditions to begin with.
The Fallout from Professional Patients
As outlined here, the participation of professional patients in clinical trials leads to inaccurate data collection and hampers the integrity of studies. Sponsors, CROs, pharmaceutical companies, and other stakeholders spend considerable time and resources to set up trials, recruit patients, and go through the various phases.
Even if the drug or treatment is promising, professional patients can make the data inconsistent enough to shut down the studies in which they are involved. Not only does this cause millions of dollars in losses, it prevents promising drugs from progressing beyond the preliminary phase(s). Who knows, maybe some professional patients were involved in clinical trials that were focused on a COVID-19 vaccine!
Preventing Professional Patients in Clinical Trials is Crucial
While participating patients are vetted through the informed consent process and an impartial institutional review board, it might not be enough to prevent professional patients from slipping through the cracks. They are constantly finding ways to falsify information so they can participate in trials.
More thorough vetting might be required alongside an effective patient identification system. Coupled together, this could help red-flag known professional patients, prevent massive losses, and significantly improve the efficacy of trials.
Salman Rashid is a Digital Marketing Analyst at RightPatient, a patient identification platform used by many healthcare providers that can prevent professional patients. He is an avid reader, is passionate about tech, and regularly writes on topics such as patient safety, compliance issues, and healthcare IT.