The persistent challenge of patient recruitment is nothing if not well-documented. It has appeared in countless journals and blogs; it exists across all phases of clinical research. Some of its causes are most common in, or even unique to, Phase I trials. The absence of medical necessity among Phase I healthy volunteers leaves little motivation to participate beyond monetary compensation, and the lack of existing information about the drug’s effect on humans can lead to the dreaded “guinea pig” fear among potential subjects.
In Phase I oncology trials, all of this is turned on its head. The decision of whether to enroll is complicated by risk, time limitations, and uncertainties surrounding new developments in oncology like immunotherapy. As a result, patient recruitment is still a challenge – perhaps more of one, even – but for different reasons. For one, Phase I oncology patients are actually sick; instead of medical necessity being absent, it is a primary concern. The worry that a treatment will have a negative effect is replaced by the worry that the treatment won’t have any effect. In Phase I trials, with all of its unknowns, this worry can be particularly acute. Persuading patients to pursue an unknown treatment plan rather than an existing one is a difficult task when their condition limits the time they have in which to act. And patients who do choose to go the clinical trial route are often restricted to just one trial, either due to time considerations or to eligibility restrictions on patients who have already participated in a trial of a similar treatment.1 As a result, patients often invest significant time and energy in reviewing numerous trials in search of the one that is closest to their ideals, creating competition for their participation among recruiters.
For patients, the urgent need to make a decision, coupled with the often limited time in which to do so, can be overwhelming. And when immunotherapy enters the picture, things can get even more intense. Perhaps the hottest topic in oncology today, immunotherapy is still in development and has both shown promise and suffered setbacks. With no consensus yet on its viability compared to traditional treatments, it can be difficult to recruit patients for the trials that hope to lead to that consensus.
Better patient recruitment through communication
So what are Phase I oncology recruiters to do? The reservations for patients can be enormously personal and emotional – more practical recruitment hurdles like the inconvenience of traveling to sites, common in other research areas, are less relevant here – and so some approaches to recruitment have focused on communication rather than incentive. Organizations have worked to raise awareness of the opportunity, through clinical trial participation, to access otherwise unavailable treatments that may be superior to those already on the market. Here, immunotherapy presents an advantage: it has earned a reputation as a major innovation; it has been shown to have more manageable side-effects than traditional treatments; it has begun to garner high-profile success stories, such as the recovery from melanoma, through an immunotherapy treatment, of former president Jimmy Carter1.
Additional potential for recruitment may lie in appealing to patients’ sense of altruism. This is especially true in Phase I oncology trials: though the patients in these trials do have a medical interest in participating, the primary beneficiaries of the treatments they receive may not be them, but future patients. In immunotherapy trials, some patients are thrilled to contribute to the development of what could be a revolutionary approach to cancer treatment that saves countless lives down the line. The Yale School of Medicine recently opened a clinical research center dedicated to Phase I oncology trials; a patient participating in an immunotherapy trial there stated, “I feel so fortunate that those of us who are in the trial can help other people in the future.”2
To attract cancer patients who possess an altruistic streak, some incentive can be a big help. The Yale Phase I center delivers this incentive in the form of luxury, offering patients private treatment areas and heated massage chairs. Besides helping to entice patients to enroll, these perks serve as a token of gratitude for their participation.
Patient recruitment for Phase I oncology trials, more so than other Phase I trials, don’t just require practical persuasion – they require empathy as well. This can make the already difficult recruitment process even more challenging. The uncertainties surrounding immunotherapy can create even more of an emotional burden for patients considering participation; on the other hand, its potential can heighten patients’ confidence and help access their sense of altruism. As medical advancements create more and more possibilities in oncology, decisions for patients and researchers alike become more complex.
1 Tedeschi, Bob; For cancer patients, newest treatments force the ultimate decision, with no room for error; STAT News; 6 October 2016
2 Moriarty, Colleen; Cancer clinical trials offer hope to more patients; Yale School of Medicine; 6 October 2016