December 19th, 2018 Are ‘Professional Patients’ in Clinical Trials an Epidemic? So-called “professional patients” threaten the integrity of clinical trials, but can they be stopped? Sponsors and CROs both know that bringing a drug, treatment, or medical device to market is a massive undertaking. The average time span of a successful clinical trial is 33.9 months, and when a clinical trial shutters due to low enrollment or inconsistent results, drug companies can lose up to $1.4 billion. It’s easy to understand why clinical trials would want to speed results along by offering patients compensation for their participation. A reward of $1000 or more per patient, which is a drop in the bucket compared to the cost of shuttering a trial, can help speed recruitment and protect against patient dropout. However, offering a fairly large sum of money in exchange for relatively little work is sure to draw some people who wish to dishonestly take advantage of the process. In the clinical trial world, these people are called “professional patients” – and they’re more common than one might expect. The Professional Patient Problem The term “professional patient” can refer to several different types of clinical trial patients. First, there are those who falsify a condition altogether in order to be admitted to a trial. They have no intention of actually being treated, but they lie about the treatment’s results in order to make it seem like they’re participating throughout the entire trial and receive compensation at the end. Second, there are patients who do have the condition that the trial is researching, but they do not actually want to be treated for it and will fake their treatment results, too. Trials that are researching treatments for addiction are especially likely to attract this type of professional patient. Finally, there are professional patients that do have a condition and actually participate in the trial, but may be participating in one or more other trials at the same time. This patient often can’t afford traditional medical care, so he or she participates in as many clinical trials as possible in order to receive both treatment and compensation. All three of these types of professional patient can confound a trial’s results and threaten its integrity. But how prevalent, exactly, is the professional patient problem? That’s the question a 2013 study from researchers at Boston University School of Medicine and Fairleigh Dickinson University set out to answer. The study uncovered a number of startling findings. Firstly, a full 75% of its participants admitted to withholding or hiding at least one piece of information from a clinical trial out of fear that they wouldn’t be admitted otherwise. 32% of subjects hid health problems, 28% didn’t disclose their use of prescribed medication, and 20% were dishonest about their recreational drug use. But more startlingly, 25% exaggerated symptoms and 14% made up a health condition altogether. Putting a Stop to Deceptive Patient Practices Fortunately, clinical trials aren’t defenseless against deceptive professional patients. Wearable clinical trial technology, a young but growing field, may be the answer to ensuring patient honesty. Companies like Fitbit and Apple both create wearable devices that monitor activity level, sleep, heart rate, and more; it’s likely that wearables will soon be able to detect levels of a drug in a patient’s body or the presence of diseases. Unless a professional patients is incredibly computer-savvy, he or she won’t be able to falsify medical data collected by a wearable device. However, wearable technology isn’t quite developed enough to solve the professional patient problem today. In the meantime, rigorous pre-screening of patients, coordination with the patients’ medical teams during treatment intake, and changing the incentive for participation can help. Many trials use large monetary incentives to speed along patient recruitment and meet enrollment goals, but a smart digital marketing strategy can help reach patients who genuinely want and need treatment, doing away with the need for overly generous compensation. Financial incentives draw real patients and professional patients alike, but with replacing monetary rewards with compelling copy, eye-catching graphics, and efficient audience targeting can help trials attract only patients who are genuinely interested in helping to bring a new treatment to market.
So-called “professional patients” threaten the integrity of clinical trials, but can they be stopped? Sponsors and CROs both know that bringing a drug, treatment, or medical device to market is a massive undertaking. The average time span of a successful clinical trial is 33.9 months, and when a clinical trial shutters due to low enrollment or inconsistent results, drug companies can lose up to $1.4 billion. It’s easy to understand why clinical trials would want to speed results along by offering patients compensation for their participation. A reward of $1000 or more per patient, which is a drop in the bucket compared to the cost of shuttering a trial, can help speed recruitment and protect against patient dropout. However, offering a fairly large sum of money in exchange for relatively little work is sure to draw some people who wish to dishonestly take advantage of the process. In the clinical trial world, these people are called “professional patients” – and they’re more common than one might expect. The Professional Patient Problem The term “professional patient” can refer to several different types of clinical trial patients. First, there are those who falsify a condition altogether in order to be admitted to a trial. They have no intention of actually being treated, but they lie about the treatment’s results in order to make it seem like they’re participating throughout the entire trial and receive compensation at the end. Second, there are patients who do have the condition that the trial is researching, but they do not actually want to be treated for it and will fake their treatment results, too. Trials that are researching treatments for addiction are especially likely to attract this type of professional patient. Finally, there are professional patients that do have a condition and actually participate in the trial, but may be participating in one or more other trials at the same time. This patient often can’t afford traditional medical care, so he or she participates in as many clinical trials as possible in order to receive both treatment and compensation. All three of these types of professional patient can confound a trial’s results and threaten its integrity. But how prevalent, exactly, is the professional patient problem? That’s the question a 2013 study from researchers at Boston University School of Medicine and Fairleigh Dickinson University set out to answer. The study uncovered a number of startling findings. Firstly, a full 75% of its participants admitted to withholding or hiding at least one piece of information from a clinical trial out of fear that they wouldn’t be admitted otherwise. 32% of subjects hid health problems, 28% didn’t disclose their use of prescribed medication, and 20% were dishonest about their recreational drug use. But more startlingly, 25% exaggerated symptoms and 14% made up a health condition altogether. Putting a Stop to Deceptive Patient Practices Fortunately, clinical trials aren’t defenseless against deceptive professional patients. Wearable clinical trial technology, a young but growing field, may be the answer to ensuring patient honesty. Companies like Fitbit and Apple both create wearable devices that monitor activity level, sleep, heart rate, and more; it’s likely that wearables will soon be able to detect levels of a drug in a patient’s body or the presence of diseases. Unless a professional patients is incredibly computer-savvy, he or she won’t be able to falsify medical data collected by a wearable device. However, wearable technology isn’t quite developed enough to solve the professional patient problem today. In the meantime, rigorous pre-screening of patients, coordination with the patients’ medical teams during treatment intake, and changing the incentive for participation can help. Many trials use large monetary incentives to speed along patient recruitment and meet enrollment goals, but a smart digital marketing strategy can help reach patients who genuinely want and need treatment, doing away with the need for overly generous compensation. Financial incentives draw real patients and professional patients alike, but with replacing monetary rewards with compelling copy, eye-catching graphics, and efficient audience targeting can help trials attract only patients who are genuinely interested in helping to bring a new treatment to market.
