The movement in making studies more patient-centric continues, as we recently featured Amgen’s new mHealth study that’s measuring migraine outcomes in patients, and Pfizer is now implementing its own mHealth study in Lupus. Pfizer is collaborating with The Lupus Research Alliance, a private funder of Lupus research to build and implement a new mobile app using Apple’s Research Kit platform through a non-interventional clinical trial called VALUE (VAlidation in Lupus of an Electronic Patient Reported Outcomes Tool) through their LuCIN program . The custom smartphone app will enable lupus patients to report on their fatigue and other symptoms in real time. In this interview, Albert Roy, LuCIN’s Executive Director, will discuss the VALUE study and how it is impacting lupus patients with the help of the Lupus Clinical Investigators Network (LuCIN).
Albert Roy: The Lupus Research Alliance has a long history with Pfizer, as we have conducted research within their clinical therapeutics and innovation branch (CTI). Pfizer was looking at technology efforts for conducting clinical trials, and they mentioned they had a partnership with Apple and were using Apple’s Research Kit in a variety of disease indications. Knowing that Pfizer has developed a Research Kit framework, we thought there could be an opportunity to do a clinical study in Lupus. So, we started discussing appropriate steps to use the same framework to build a Lupus-specific app, and run a clinical study to improve outcomes collection for Lupus patients. The purpose of this app is to address how technology could facilitate patient reported outcomes in clinical research.
MA: What patient reported outcomes (PROs) is the Lupus study mobile app measuring, and how is the mobile app different than traditional PRO data collection methods if you’re collecting the same data?
AR: Studies in Lupus look at three instruments that determine a patient’s disease activity. One is by measuring certain aspects of how the patient is feeling on a global assessment range. The second instrument is the short-form 36, a health survey that has 36 questions to measure functional health and well-being from the patient’s point of view. It is a practical and reliable measure of physical and mental health. It can be completed in 5-10 minutes and it is a generic health survey that can be used across all diseases and treatment groups. The third instrument we wanted to look at is the patient global assessment. It is a visual analog scale from 0 to 10 and is based on an algorithm. The patient moves their finger along the scale based on how they are feeling and it calculates the score. The higher the score, the worse the disease and their global health. Traditional patient assessments in Lupus are unfortunately done in a very arcane way; it requires the patient to come to the clinic and complete a paper form. Lupus patients don’t come to the clinic every week unless they are very sick, so they have to recall weeks and weeks of how they felt and address the question in the most accurate way. We wanted to reduce this burden on the patients and see if we could translate all these instruments from paper into an electronic format. Running the mobile app is an opportunity for patients to do the assessment on their own, in the comfort of their homes and on a smartphone. We could get more accurate data since they would be able to answer these questions once or twice a week versus once a month. We could measure that against paper form submissions to see what would be more effective—Is the paper form just as good/worse/better than the electronic version?
MA: What functionality does the app provide that is an advantage over paper-based PROs?
AR: The app offers flexibility and convenience to patients. For example, with the SF 36, if you’re taking it on paper in the clinic, you have to finish 36 questions in a 5-10-minute timeframe before you see your doctor. There isn’t an opportunity to go back and think about or change your answers or take a break or take it home with you. On the app, you have the ability to complete the SF 36 with a longer and more flexible timeframe, so you do not need to answer all 36 questions at once. You can answer a few, then come back to it and pick up where you left off. You also can set alerts that remind you to complete the assessments. Another advantage is that the site will have the ability to remind the patient to complete their instruments.
MA: Are you collecting any additional data from patients other than the PROs (i.e., biometric data) through wearables? How are you assuring data integrity and security on iPhones?
AR: There was some discussion about trying to link an Apple Watch for the study surveys and to collect biometric information; however, we discovered that it would get too complex because of the type of data that we are collecting, and due to the ethics and IRB issues at the institutions. We have capped the data being collected to be focused on these three PROs and not get into factors like the number of steps taken. The patient cannot use their own smartphone for the study; they are given a study-specific iPhone, which has texting, calling, and internet capabilities, but they will not be able to download additional apps due to data integrity. The only app that will be active on the iPhone is the app for the study.
MA: Can you describe LuCIN?
AR: LuCIN is a network made up of academic research centers that the Lupus Research Alliance has had a long-standing relationship with. Exclusively in North America, we have 59 sites—50 of which are in the United States—and nine are in Canada. We add value to the clinical trials process, specifically around recruitment of investigators and sites, and the design of clinical trials. We have Lupus experts and a significant number of patients that are within the Lupus network. Our studies run the gambit of the clinical trials from drug interventional trials, where the drugs were previously approved for another disease indication and are being repurposed for Lupus. We also look at non-drug interventional trials, such as using new technology like the Lupus app we just discussed for ePROs. We are looking at innovative imaging modalities assessing organ systems within Lupus patients, and are implementing non-repurposed drug trials with innovative therapies for Lupus. We have a pretty good portfolio of diverse trials and we are excited to get underway.