Informing the Protocol Building Process with the Patient in Mind

By Maxine Bookbinder 
July 15, 2014 | In response to increasing pressure on biopharmaceutical sponsors to offer lower-cost, shorter-duration, and patient-centered clinical trials, a pharma veteran has started a company offering patient feedback—before trials—designed to help sponsors and patients by improving patient experience and reducing clinical trial cost and time.  
“Despite improved technology, trials take as long or longer now, cost more, are more complex, and patient needs still haven’t been met,” says Abbe Steel, founder and CEO of HealthiVibe, who spent 24 years in the life sciences industry focused on patient recruitment, retention, education,  adherence, and marketing.  HealthiVibe “was born out of frustration of not seeing patients’ needs included in the clinical design process. The patient voice hasn’t risen the way it should to help patients and bring drugs to market faster.” 
Steel recalls participating in several investigator meetings in which site staff complained that the   protocol wouldn’t work with their patients, resulting in protocol amendments even before the first patient was enrolled. “We rarely ask patients what they think about study requirements. They sometimes spend a year or more in a trial. They miss work, travel long distances, and take their kids out of school. Patient participation in clinical trials is often more demanding than traditional standard of care. Some patients have told me they don’t even get a ‘thank-you.’” 
HealthiVibe emerged in April 2014 to provide a systematic, structured process to obtain patient feedback at the protocol level. While its clients are pharmaceutical companies, the mission is clear: to enable patients to contribute to the design and conduct of clinical trials, resulting in faster, more effective and less expensive research and development that ultimately meets patient needs.  Steel’s structured process addresses precise questions and specific trial issues; a multi-functional team includes former trial participants, pharma researchers, and subject matter experts who design and execute qualitative and quantitative global market research.
The client gives Steel a draft protocol. The next step is to obtain feedback from patients and caregivers, through advisory boards, phone calls and focus groups, exploring operational considerations of trials, insights around endpoint development, and feedback on unmet patient need. “We look at the things that make or break a trial. If someone dropped out, why?”  
HealthiVibe then develops a survey from this feedback and fields a survey from a global, consumer panel of 10 million people providing a representative patient sample. “We want the ‘every man on the street,’” says Steel. “We want the guy pumping gas or the mom taking her kids to school.”   Respondents are not required to have participated in previous trials or be actively engaged in a patient community.  The survey results are analyzed and packaged with specific, actionable recommendations and then given to sponsors for consideration. Respondents are not currently recruited for trials. 
“We want to give sponsors actionable, meaningful feedback before they start a trial. This allows sponsors to focus on areas of risk and modify things before finalizing the protocol,” notes Steel. “They might consider things like hiring a patient recruitment vendor, reducing or combining study visits, collecting specific patient outcomes, or utilizing new technology such as wireless glucometers.”
Steel is assembling metrics and collecting data but says it is too early to determine HealthiVibe’s impact or to quantify hard data. She has not published case studies yet but adds that “the scientific rigor can hold up to publishing.” 
Steel says her goal is to relieve patient burden and stress, identify specific drop-out risk areas, and increase patient retention and, ultimately, improve trial recruitment rates.  “The terms ‘patient engagement’ and ‘patient centricity’ are overused. At HealthiVibe, we ask, ‘How do we capture the patient voice and involvement?’” Eventually, she would like to incorporate brief, blinded end-of-trial feedback surveys, as well. “Some things we can’t control,” says Steel. “Let’s work with the things we can control.”