April 29, 2013 | Guest Commentary | “It’s easier for patients and it makes us more efficient.” Laurie Jassenoff, Vice President of Clinical Affairs at Palm Beach Research Center, is talking about the benefits of electronic patient reported outcome (ePRO) systems for collecting data from clinical research patients. 

Headquartered in West Palm Beach, Florida, the Palm Beach Research Center’s therapeutic expertise includes arthritis, asthma, back pain, constipation, diabetes, diabetic gastroparesis, IBS, knee pain research, osteoarthritis, and psoriasis.  

The majority of new trials use ePRO systems to improve patient data quality, and protocol and regulatory compliance. Jassenoff estimates ePRO systems save patients and staff between 25 and 40% of the time it takes to conduct paper-based clinical studies. And, they increase patient compliance about 33%. 

Patients give too little or too much information with paper diaries. For example, paper questionnaires for a knee pain study asked participants if it hurt to run up and down stairs. One patient wrote that he lived on the first floor, so he didn’t know what he should write. Patients must complete ePRO questionnaires accurately and in the correct order. They can’t add unrequested information.

When Jassenoff’s staff is working on a study that uses paper diaries, data lock—the time and date the sponsor agrees they will not submit any more patient data to support their New Drug Application (NDA)—is less likely to be on schedule. “A lot of time is lost when coordinators have to enter patient information into the eCRF,” she says.  “We don’t know if a subject is being compliant with a paper diary,” Jassenoff said. “Why would a sponsor or CRO want to enter data manually when it can be seamlessly integrated through electronic devices?” 

 

Without real-time access to accurate patient data, study coordinators also can become concerned about the safety of the patient and their ability to participate in a study. 

And, paper diaries are more likely to be misplaced, lost or destroyed. “With paper diaries I’ve actually heard ‘my dog ate it,’” Jassenoff laughed.  

Patients of all ages find eDiaries easy to understand and use.  Coordinators find that patients enjoy reviewing their completed questionnaires during follow-up visits, which can be up to an hour shorter than paper visits. 

If patients have an iPhone or a mobile device they can complete their questionnaires anywhere.  Patients complete questionnaires through their device or a study-specific software app. The ePRO System automatically loads the data to an online reporting portal and transfers it, sending custom reports and metrics to the sponsor or CRO.

Because data is integrated into EDC systems and can be reported immediately, coordinators are more likely to know if a patient is qualified. Palm Beach Research Center uses its enrollment metrics to track patients in real time.  With ePRO Systems, Jassenoff gets emails alerts only for patients who aren’t completing their diaries on time. She forwards the emails to the study coordinator, who contacts the patient. 

Even for pediatric studies of infants when you can’t get first-hand PROs, Jassenoff points out that you can collect good observational PRO data by recording parents’ or caregivers’ observations of a child’s reactions to a new drug. 

In addition to the handheld eDiaries, the Palm Beach Research Center uses other devices like PEF meters for Asthma and COPD studies, and Glucometers for Diabetes. These devices patients take home relieve the pressure of “White Coat Syndrome.” Patients can become anxious visiting a site, or they might have had coffee or other caffeinated beverages before their site visit. These portable devices enable 24 hour monitoring so coordinators can see what’s happening with the patient after they leave the site.

Laurie Jassenoff says using ePRO Systems also improve Palm Beach Research Center’s operations. They eliminate duplication because the team enters the data once. They can review data, enrollment, and compliance and send custom reports to the sponsor quickly. When they do QA for studies, it’s easier to enter data.

With mobile reporting, study coordinators aren’t tied to their computers. They can walk around with their mobile devices and get instant metrics to see if patients are compliant, and if they aren’t their site visits can be rescheduled. 

The Palm Beach Research Center staff is enthusiastic about enabling patients to use the web to participate in clinical research programs. Jassenoff explained, “The cost savings is incredible when you think about a patient who doesn’t have a phone line at home and needs a wireless device. Patients like going wireless.  And sponsors and CROs don’t have to pay for devices or telecommunications costs.” 

The world is moving to faster and better technology based devices are available. “Personally I find it fantastic that as a clinical researcher I’m able to  use electronic methods to collect patient outcomes,” Jassenoff said.