A major driver of patient recruitment hurdles in Phase I clinical trials could be described as the perceived distance between researchers and subjects. Researchers can appear only interested in mining patients for data, unconcerned with any health risks posed by a compound whose safety profile has yet to be determined. This perception is not-so-affectionately referred to as the “guinea pig fear,” and has long been a persistent cause of headaches in Phase I and beyond. Adding insult to injury is the reality that it is misguided, that clinical researchers by and large view patients not as subjects of experiments, but as partners in the advancement of medical science. The good news is that, through the recent surge of investments in patient engagement campaigns, the industry is ramping up its efforts to better communicate this reality to potential and actual clinical trial patients. If patient engagement efforts can help close the perceived distance between researchers and subjects, will recruitment and retention efforts begin to see better results?
Discussions and coverage of patient engagement tend to center around relatively recent innovations like social media campaigns and incorporation of patient input into study design. But amid these developments, it’s important not to lose sight of the patient engagement potential of patient reported outcomes (PRO), which have been collected as a standard aspect of clinical research for years. The collection of PRO is a key method of communicating to patients that their experience, not just the data they provide, is crucial to both the conduct and conclusions of the trial. This is reflected in the work of some of today’s top patient engagement innovators: AKU Society, for instance, included PRO as part of a larger patient engagement strategy that has yielded impressive results in patient recruitment. It’s also a major motivating factor behind the development of Medrio’s tablet-based PRO application, one of three products in Medrio’s eSource suite.
Here are a few ways that PRO, especially when bolstered by eSource technology, can be a useful patient engagement tool for dealing with some of the challenges researchers often face, particularly in Phase I.
PRO to beat the “guinea pig” fear
The foundation of the guinea pig fear is the notion that researchers are willing to subject patients to harm in the interest of acquiring the data they need. This can be particularly unsettling for patients in Phase I, in which the safety profile of a compound is still unknown and the risk factor can seem higher. A strong focus on PRO upends this notion. By providing patients the opportunity to report their reactions to a treatment in their own terms, researchers clearly demonstrate their investment in documenting any adverse events a patient may experience, and modifying the treatment accordingly. This allows researchers to show that they aren’t just observing their patients; they’re listening to them as well. And as responses entered in Medrio’s eSource PRO application sync automatically into Medrio’s EDC, patients can rest assured that their responses are secure, accessible, and can be acted upon quickly.
For Phase I with patient populations
In Phase I oncology trials, which enroll sick patients instead of healthy volunteers, a primary deterrent to enrollment is the fear that the compound, rather than cause any adverse effect, will be less effective than treatments already on the market. PRO allows researchers to be more responsive to this concern, adding a human element to their assessments of how well a compound is working against a patient’s disease. In addition to data gleaned from blood draws and X-Rays, conclusions about a treatment’s effectiveness are informed by whether patients actually feel better or worse or are experiencing any side effects. And recent FDA guidance encourages PRO in oncology trials to focus largely on disease-related symptoms, reinforcing patients’ potential to express any concerns they may have regarding an experimental medicine’s effectiveness in treating their disease.
Patient engagement, especially through a focus on PRO, aims to provide an antidote to recruitment hurdles by treating patients as collaborators in research whose experience and concerns matter as much as the data gathered from them. Across all types of Phase I trials – both those involving healthy volunteers and patient populations – PRO efforts are made more convenient and efficient when equipped with eSource technology. Medrio’s eSource PRO application is designed specifically for use in the clinic, making it even better tailored to Phase I, in which patients spend more time on site. This application represents Medrio’s biggest contribution to the wave of patient engagement efforts sweeping the clinical research industry.