Pain is a universal human experience—and finding ways to relieve or better manage it continues to be a priority for the life sciences. Fifty million American adults live with chronic pain, and even more cope with acute or episodic pain. The challenge of accurately assessing pain in clinical research applies to many therapeutic areas, from arthritis and migraine to GI and oncology. While everyone experiences pain, its intensity and severity are subjective, which makes measuring pain tricky. Most pain clinical studies rely on patient reported outcomes, but too often these PROs are marred by a combination of bias and compliance issues that can call data accuracy into question.
When a decentralized clinical trial is carefully designed and implemented, these data accuracy concerns can be reduced significantly. Here are five considerations when virtualizing a pain study:
Transitioning validated questionnaires like the Numerical Rating Scale (NRS) and Visual Analog Scale (VAS)from paper to digital formats can cause consistency issues. Smartphones and tablets come in many different sizes; many ePRO technologies are not as adaptive to screen size as they need to be and this matters more than one might expect. Even small variations in line breaks can cause participants to infer a different meaning, creating data accuracy issues and skewing study results.
Study teams must preserve the integrity of questionnaires in a digital format. Participants should see the information presented the same way – no matter what type of device they are using. It is incumbent upon study and app designers to ensure this is the case.
Since ePRO is a primary source of evidence in DCT pain studies, protocols often include multiple daily questionnaires. Patients can find these monotonous, and often they tire out, resulting in low compliance. Living with pain can also make it tough for participants to complete daily diaries.
Fortunately, the newest generation of apps are easier to navigate, with more user friendly and interactive scales to answer intensity questions. Companies like ObvioHealth have created functions like the pain indicator that allow the user to log a pain event with the click of a button ,making it easier to track the time and frequency.
Another challenge with ePRO is that patients who forget to report may not retain a clear memory of the duration or intensity of the pain event. The more time goes by, the more difficult it is to remember. This is where ongoing support from the study team becomes essential. ObvioHealth’s COACH (Clinical Oversight and Coordination Hub) team monitors reporting in real time so that they can detect and resolve compliance issues more quickly. Team members can personally reach out to participants and encourage them to get back on track. The team also provides regular touch points to answer questions, ask about symptoms and intervene in case of a suspected adverse event.
Pain trial findings are often skewed by unreported rescue or concomitant medications. Participants may use these drugs out of habit, to strengthen the effect of the study medication or because they are using a placebo that doesn’t provide relief. To conduct a successful study, sponsors need to ensure patient safety and comfort while preserving data integrity.
ObvioHealth’s app makes it easy for participants to report a concomitant medication anytime by asking them daily whether they took any medications or supplements outside of the study product.
Since pain is highly subjective, it’s often difficult to gather unbiased evidence in a clinical trial. That’s why patient training is critical to the success of a pain study.
Giving patients guidance into the trial process can help them understand how to use scales such as the NRS and VAS. In addition, researchers have found that educating patients about the placebo effect can reduce placebo response rates by over 50%.
For a virtual trial, patient training should be accessible within the same platform where data is collected so patients can easily refer to the educational materials at any point during the study. Training in the virtual setting can also be more engaging with quizzes, videos and progressive disclosure that gives patients the information they need at each step of the process.
Digital tools can help researchers find new ways to uncover evidence of pain, relying less on subjective patient reporting. These tools can connect the dots between data points to better characterize pain, which ultimately helps develop improved diagnostic and treatment tools.
Sponsors can identify novel outcomes by aggregating various data sets—for instance, declared data and mobility data. Some potential applications could include:
· Using a digital device embedded in a patient’s shoe to measure pressure points that indicate how pain in their back or leg affects their gait
· Asking patients to “deep press” a button on their smartphone to indicate their pain level, similar to squeezing a finger to show how much pain they’re in
· Capturing “selfie” videos of participants showing their facial expressions associated with different movements, like sitting up or moving extremities
Preventing acute pain from worsening into chronic pain is a major priority within pain management.
Now, a new ObvioHealth partnership with Dedalus Group is poised to help sponsors and other research organizations to conduct more longitudinal pain research by offering access to meta-data insights from electronic health records of large patient population over time. These meta-data insights may reveal correlations between pain and comorbid conditions that can enable more targeted treatments.
For as long as humans have pain, researchers will need to innovate new treatments. Virtualizing pain-related clinical trials offers the possibility for breakthrough research on this debilitating condition. Harnessing real-time data and novel outcomes can help sponsors bring new treatments to market and improve millions of lives.