Inspire Plays Pivotal Role In Search For Super-Genes
By Deborah Borfitz
February 9, 2021 | The pilot project of a new HealthJourney program being developed by healthcare social network Inspire is all-virtual recruitment for a clinical research study being conducted in partnership with Pfizer, the Manton Center for Orphan Disease Research at Boston Children’s Hospital (BCH), and Citizen Genetics. The study is endeavoring to identify people in families with a history of autoimmune disease who carry “super-genes,” variants that make them resilient to lung cancer progression, according to Richard Tsai, Inspire’s senior vice president of marketing.
By traditional means, finding research participants would be difficult at best, he says. The study population includes individuals with a past diagnosis of lung cancer who have been in remission or had no evidence of disease, ideally for at least the last five years, as well as an historical diagnosis of early- onset eczema or atopic dermatitis—together with other family members who exhibit similar traits—all of whom need to consent to submitting blood or saliva samples for DNA sequencing and to share their medical records.
In the past, Pfizer researchers had considerable difficulty finding a cohort of patients who met the criteria so its research hypothesis could be tested, Tsai says. They proposed the collaboration after learning about Inspire’s plans to build out the HealthJourney platform.
It took Inspire only a few weeks to identify more than 100 eligible and willing patient/family pairs for the Patient Forward Access to Clinical and Technological Research (PFACTR) study that launched earlier this year. The enrollment process, which is being handled by Alan Beggs, Ph.D., and his team at BCH, is now well on schedule, says Tsai.
BCH is the main clinical research and patient enrollment partner for its expertise in rare diseases, clinical genetics, and the Manton consent protocol, which is a global digital consent process that has been approved by the hospital’s institutional review board, he adds.
Inspire has assisted with hundreds of clinical trials, either to gather patients’ perspectives on protocol design or to help generate awareness and recruit patients into studies, Tsai continues. In more recent years, Inspire has also been called in to rescue poorly enrolling studies that even sweeping advertising campaigns could not fix.
But this was the first time the organization was tapped to help potentially make novel genetic discoveries from its community, by identifying and screening study participants and introducing them to the clinical investigator, Tsai notes. Inspire already had enough basic and deidentified phenotypic data about its members to know who might be interested in the PFACTR study, which helped it quickly reach the enrollment goal.
The study is headed up by Beggs, director of Manton Center and professor of pediatrics at BCH. The Manton Center is handling the informed consent process, says Tsai, which includes the option for participants to receive medically actionable (per current American College of Medical Genetics recommendation) genetic sequencing reports that may impact their health, such as inherited risk for cancer.
The option comes with access to a genetics counselor—a preference voiced in Inspire’s member survey on patient perception and experience of genetics research conducted in 2018, Tsai says. No one has asked to be dropped from the study once enrolled.
Citizen Genetics, a patient-centered contract research organization, is helping to manage the genomic research capabilities, working with vendors to build genomic sequencing kits, handle logistics of the biosamples, and perform sequencing, he says. Most study participants have chosen to self-collect samples at home rather than travel to a local lab to have it done.
The end goal is to identify a potential genetic driver of lung cancer and possibly a target for drug development, says Tsai. Much more follow-on basic research at the bench will be needed around results coming out of the PFACTR study before further clinical studies can proceed. The team wants to publish findings and share them back with participants and the community at large, he adds.
Next-Gen Online Health Community
Inspire HealthJourney has yet to formally launch, says Tsai, but the idea is to build a next-generation online community where patients have access to their own medical data and are able to interact with each other and compare experiences with others who have been where they are at.
Inspire collectively has more than two million members engaged in over 3,600 disease areas, and many of those support communities (for patients and caregivers) are exclusively partnered with a national patient advocacy group that helps manage the group. HealthJourney is a means for them to accelerate research and life-changing discoveries by leveraging cloud technologies so they can “share [their] consented, real-world voices, medical records, and self-reported health experiences,” he says.
The PFACTR study about genetic influences on lung cancer and atopic dermatitis is the first of potentially many collaborative trials, Tsai adds. The areas expected to be explored next include a cardiovascular disease and an orphan condition where over 60% of the estimated total patient population is already engaged in an Inspire community.
Patients who have opted into an Inspire support community generally can learn more about relevant clinical trials offered by sponsors and advocacy partners via webinars and online post-and-reply exchanges with investigators, says Tsai. One of its more active partners, the Melanoma Research Alliance, has also implemented a community-specific clinical trial finder tool.
Trials overall have had noticeably more digital components and synthetic control arms sourced with real-world data since mid-2020, Tsai notes. But many companies with novel digital solutions that are supporting pharma in the shift are still turning to Inspire for help in accessing the specific patient populations they need to engage, especially for cancer, rare diseases and other symptomatic chronic conditions.
A recent survey of about 1,300 Inspire community members found that some of them were “really upset” that COVID-19 put a halt to a clinical trial that was their only remaining therapeutic option, says Tsai. Clinical trials in general have generated less interest from would-be participants since the pandemic hit. The PFACTR study has been a striking exception.