Advisory boards amplify patients’ voices
A strong and growing desire to solicit feedback directly from patients, experienced participants and their support network is prompting many sponsors and CROs to assess, plan and implement patient advisory panels.
This feedback is providing valuable new insight into protocol feasibility, ways to improve study positioning and patient recruitment and retention communications, and clinical trial medicine kits. A select number of sponsor companies are even hoping to make patient advisory panels a compulsory part of study design and operations planning.
Feedback from advisory panel members is coming from a number of sources. Some panel members are drawn from communities who have extensive experience dealing with and caring for a disease. Others are former clinical trial participants and caregivers. But advisory board members are not currently active participants in clinical trials.
Sponsors and CROs are trying a variety of formats and approaches to solicit advisory panel feedback. The most labor-intensive and targeted approach has been one-on-one interviews. Approaches with the most extensive reach include automated online feedback, crowdsourcing and social media communities.
Ultimately, patient advisory panels hold the promise of accelerating study startup and overall cycle time, improving recruitment and retention, and gathering more relevant clinical trial data.
There are a number of for-profit companies and a nonprofit organization providing services designed to solicit feedback from patient advisory panels. Here, CenterWatch profiles three examples.
Startup company HealthiVibe’s approach is to obtain rapid feedback to conduct mock clinical trial simulations and utilize online, crowd-sourced surveys from its database of 10 million patients. The company has experience running focus-group format and Web-based virtual patient advisory panels.
“We want to know how patients on the panel view their disease, how they were diagnosed, how they live with their condition, how they make treatment choices and what considerations are important to them when considering a clinical trial,” said Abbe Steel, CEO of HealthiVibe.
“When we drill down further to better learn what patients think about, they ask about the kinds of medical tests and the number of visits. They want to understand why they need so many MRIs or why their fourth study visit is four hours long—which, we explain, is because it involves an infusion,” said Steel.
The Center for Information and Study on Clinical Research Participation (CISCRP), an independent nonprofit organization, has been conducting patient advisory panels for nearly 10 years. Although CISCRP has organized and moderated online advisory panels, it prefers to hold single or a series of face-to-face meetings among seven to nine panel members. Most CISCRP panels are constituted and implemented in coordination with disease advocacy groups.
“One of the things we always see is that patients have opinions and ideas about the way clinical trials should best be run,” said Zachary Hallinan, CISCRP’s director of patient communications and engagement programs. “Patients are often being asked to do things that are inconvenient or that patients cannot relate to. Patients receive messages about clinical trials that don’t speak their language. It’s the patients’ viewpoint that has typically been overlooked by professionals writing and supporting protocols,” said Hallinan.
“We found that listening to the patient voice early in the clinical trial planning stages really helps the clinical teams design and execute better studies,” he added.
According to Hallinan, since it began conducting advisory panels, CISCRP has engaged patients for their feedback on protocol design feasibility, endpoint and outcome measures, informed consent form design, study branding and communication, patient compliance, clinical trial medicine kit design and administration, clinical trial participation technologies, and study-specific materials (e.g., new support materials and post-trial communications).
Private equity-funded Transparency Life Sciences takes a very different approach by relying on crowdsourcing and mobile health technology to develop clinical trial protocols. The company retains an ownership stake in each project and solicits financing for future projects from foundations, private equity, crowd funding and potential partners.
Unlike advisory panels that rely primarily on patients, Transparency’s crowdsourcing uses a combination of patients, physicians, researchers and other stakeholders to contribute input into the design of a client’s protocol. The company uses its proprietary TLS Protocol Builder—a crowdsourcing survey tool—to ask specific questions relating to each compound’s indication and clinical trial design.
The company recently completed a protocol design for testing lisinopril—an ACE inhibitor that treats high blood pressure and heart failure—to combat multiple sclerosis. A second generic offering, metformin, is a widely used oral drug for diabetes control that is being tested in men after they underwent prostate cancer surgery or radiation to prevent a reoccurrence.
Transparency Life Sciences maintains that its extensive Q&A approach will reduce clinical trial costs by at least 50% through partnerships with new technology providers. The company also is using mobile health technologies and telemedicine with the goal of reducing the burden of study volunteer participation while enhancing data quality for sponsors.
“We have different philosophies and don’t believe a five- or seven-patient panel can make a substantial difference in the protocol and clinical trial efficiencies,” said Transparency founder and CEO Tomasz Sablinski, M.D., Ph.D. “Once a study design document is in semifinal form and subject to review, there is significant resistance to change. So changing existing documents is quite difficult. Asking physicians, patients and researchers—and anyone else who wants to contribute to the design of the protocol—is a paradigm shift. Our approach has been accepted by the FDA,” he said.
For some sponsors, the opportunity to alter their current approach to clinical trials and be more patient-centric by using patient advisory panels has shown significant promise.
“Using advisory panels helped us launch a mock trial simulation for our phase III study where the feedback provided highly valuable information—it was amazing,” said Deirdre BeVard, vice president of development operations at Nektar Therapeutics, who turned to HealthiVibe for real-time feedback that she called an “intensive and immerse process.”
“Using simulations that included an experienced investigator and coordinator—and real patients—with our chronic lower-back pain medication, we gained insights and feedback for many different things,” said BeVard. “They ranged from new educational materials for patients [to] study tools for our sites. We changed the graphics and instruction images on our packaging,” she said.
“The process also led us to create a more patient-friendly adherence to the study schedule that was hopefully less burdensome, along with helpful tools for trial participants that did not require them to need to refer back to the consent form,” said BeVard. “We also gained insights into how best to train investigative sites. HealthiVibe has been a great partner in our efforts to incorporate the perspective of the patient and the site into the way we operationalize our clinical trials.”
At EMD Serono, a patient advisory board session might last four to six hours and enable the seven- to nine-member panel from CISCRP to discuss a variety of issues, according to Vice President Paulo Moreira, who heads global clinical operations and external innovations. He said the company has conducted several clinical trials using different patient advisory panels for every study the company launches. He added that each panel is comprised of patients, including two from patient advocacy groups and others who are former clinical trial patients and people who have never participated in a trial.
“For us, the operational implementation of the clinical trial is very important to make sure patients understand the number of visits, the number of procedures like blood draws and other tests that have to be performed during the site visits, and the intensity of those procedures,” said Moreira. “We are also aware of [the scheduling of] those visits and want to make sure that the time spent and distance traveled is not too burdensome.”
After just a few panels, EMD Serono said that it has seen a positive impact from the early feedback including changes to make studies more feasible and smoother and more effective patient recruitment. To ensure that clinical teams understand the patient’s view, CISCRP holds sessions with the advisory panel in one room. A team of EMD Serono researchers observes and listens next door through a one-way mirror.
“We usually start with protocol design, and then move to informed consent to make sure that patients understand the messaging is appropriate, and then go to ancillary things such as data collection—ePRO, diaries and quality-of-life questions. We’ve built an infrastructure where, with CISCRP, every time we start a new trial, we will assemble the advisory board. We think of it as our new standard.”
This article was reprinted from Volume 22, Issue 09, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>