Dr Gordon E. Crofoot has practiced on the forefront of medical care and research caring for Houston’s LGBQT community for thirty years now, combining a clinic and trial site for comprehensive, culturally competent care for one of America’s (and the world) most diverse cities. Established as a unique private clinical practice, Dr. Crofoot offers targeted, empathetic and comprehensive care to vulnerable populations, including the LGBTQ (Lesbian, Gay, Bisexual) community—in addition to a growing Black and Hispanic/Latinx case load impacted by the virus. The Houston-based physician’s earned the credentials and, importantly, the “street cred” on the ground having practiced medicine with special attention to HIV/AIDs, Hepatitis and other infectious diseases—and the communities this disease has impacted for years. The HIV crisis led many clinics’ move to embrace research, representing a natural progression. In fact, it was HIV/AIDs-focused clinics such as Crofoot Research Center that in fact helped pioneer clinical research as a care option movement. Frankly, there was little choice as a killer virus had no treatment, meaning research was the only key to saving lives. And establishing a clinic and trial site center sensitive to the needs of its patients’ community built a strong and growing following of patients. This led to a growing research arm with prominence and respect, now offering site research services for Phase I-4 studies in infectious disease and vaccine studies. By late 2019, Crofoot Research Center was selected to serve as a research hub representing the metropolis that is Houston in the 3,800 HIV-negative Mosaico study, the only Phase 3 efficacy study for an HIV vaccine. Taking on ever larger, more complex studies, this Houston-based trial site needed to evaluate its systems and processes to ensure it could take on and manage important, larger efforts while maintaining its core community ideals, as well as a dedicated commitment to ethics, patient safety, and quality. The trial site adopted the Site Vault system and embarked on an ongoing mission to transform the practice from one that was 100% manual and paper-based to a research operation that’s now 100% digital when it comes to documents associated with clinical trials. Recently, the center expanded its digital capabilities by becoming one of the first trial sites in the world to have a patient complete an electronic consent in Veeva’s new eConsent platform.
TrialSite’s founder Daniel O’Connor caught up with Crofoot Research Center’s Charles Sydnor, CCRA, ACRP-CP, project manager for the trial site organization. TrialSite, using transparency and research accessibility from the site perspective, was intrigued that this Houston-based organization was one of the first sites to make use of the Veeva eConsent cloud-based service, a MyVeeva for Patients application built on the Veeva Clinical Network.
What’s this site’s background, why is it unique, and how did they find their way to a cloud-based, digital regulatory binder and eConsent service? TrialSite profiles in Site Watch Leading Crofoot Research Center in Houston.
A Commitment to a Cause
While COVID-19 still rages, anyone with any age under their belt knows all too well of the terrible HIV/AIDS epidemic that started in the 1980s and continues to this day, although far more contained thanks to a combination of research, medical treatments, and committed patient advocacy.
While major breakthroughs have made the prevention and treatment of HIV far better, still several thousand new HIV transmissions occur every day. By 2017, up to 25,831 people struggled with HIV in Houston, America’s fourth largest city and a metropolis that documented 1,133 new cases that year, according to a profile of the Crofoot Research Center last year.
Minority populations now bear the brunt of the HIV/AIDs pathogen, as in Houston, the African American population had the most infections at an estimated 48.2% followed by Latinos at 34.8% and 12.9% for white transmission. Trans-communities also struggled disproportionately with this condition, and Dr. Crofoot’s clinic has evolved and adapted the practice and trial site facility over the years to become ever more inclusive, applying empathetic care to many thousands of patients annually.
The Fight Against HIV/AIDS Continues
While the use of PrEP (pre-exposure prophylaxis) has made a big difference to manage what in the early days of the 1980s was a literal death sentence, the HIV infections and associated deaths still occur all too frequently. And some new disturbing trends have emerged. Not long ago, TrialSite’s Daniel O’Connor interviewed Duke University’s Schenita D. Randolph, PhD, MPH, RN, CNE and Ragan Johnson, DNP, MSN, APRN-BC, on the Duke University School of Nursing’s effort to utilize various innovative community channels to promote HIV prevention and awareness among Black women in the American South. TrialSite learned and reported, thanks to the Duke University-based research, that Black women in that region of the nation become infected with HIV at a faster rate than any other group in the country. This HIV epidemic hasn’t gone anywhere and, in fact, has shifted to include new vulnerable populations.
On the topic of HIV/AIDS and Houston (and the South), Dr. Crofoot quoted last year in OutSmart, “Houston, and the South in general, unfortunately bear a disproportionate burden of new and overall HIV infections for a variety of reasons.” The principal investigator continued “It is important to look at key places where the HIV epidemic is still a concern in order to look for ways to stop it. Additionally, Houston is the most diverse city in the U.S., and research needs to ideally reflect the makeup of the population. You need to study ways to prevent HIV in all persons, not just one group. Houston is a great place for clinical research because, hopefully, we can get participation from a very diverse group of volunteers.”
Crofoot Research Joints Global HIV Vaccine Study
With continued need for more prevention and protection, by 2019, Crofoot Research Center was selected to participate in the global Mosaico study (NCT03964415) to investigate the use of an investigational HIV vaccine called Ad26.Mos4.HIV, a novel tetravalent vaccine.
This mosaic-based vaccine candidate contains mosaic immunogens that were developed using genes from a number of HIV-1 subtypes with the goal of delivering a global vaccine deployable anywhere in the world.
Welcome to the Big Time
With site activation and study start up, Crofoot Research Center became more visible on the global HIV research landscape, participating in what was one of the largest, most prominent infectious disease trials in the world, serving as a research hub for America’s 4th largest city.
While still small in size (the clinic employs about 20), this community-centric clinic and research practice, took on nearly 20 trials concurrently, joined global HIV vaccine studies, and consequently became a trial site of choice for select infectious disease and vaccine research endeavors. Global sponsors (pharmaceutical companies) had this trial site on the list for new relevant studies.
Clinical research sites operate in heavily regulated environments, meaning that policies, processes, systems and tools must be designed and executed in such a way as to continuously bolster and augment quality operations, also known as good clinical practices. Moreover, with changes in the industry, promulgated by ICH E6R2, and embraced by the U.S. Food and Drug Administration (FDA) an emphasis on risk-based compliance practices necessitated ever more sophistication and expertise at the trial site.
In theory, the FDA can pay the trial site a visit at any time for an inspection—a review of practices, procedures and whether the site adheres to the study investigational plan.
While site compliance with FDA has been a constant, the global regulatory landscape gets ever more sophisticated necessitating trial site investments in systems, processes and talent, and part of this means the inevitable trial site shift from a paper-based clinic to a digital research center.
While most clinical trial sponsors, that is biotech and pharmaceutical companies, adopted electronic trial master file systems as well as electronic portals over the past several years, trial sites, on the other hand have taken longer to transform the clinics and practices. While electronic medical records systems were in place, the important site trial master files, also known as site regulatory binders, were for the most part, all paper.
Charles Sydnor with Crofoot Research Center shared with TrialSite in a video call this week that they were no different, managing all of their clinical trials with paper-based regulator binders. Sydnor acknowledged that as the practice grows, takes on more studies, and patients and activity, that this paper-based world made it more difficult to scale.
Adoption of Site Vault
In “No Site Left Behind,” TrialSite shared that Veeva, a Pleasanton, California-based software vendor, one that completely disrupted the pharmaceutical research sector with its cloud-based software solutions over the past several years, kicked up the disruption level notches a couple levels back in late 2019 when it offered SiteVault Free at no charge to clinical investigational sites. TrialSite absolutely applauded this effort; it evidenced more than just marketing gimmick but actually an authentic commitment to the trial site community.
Most independent trial sites, such as Crofoot Research Center, lack deep pockets—they are not large corporations, but rather, operate as medical services providers operating in difficult, competitive, highly regulated U.S. healthcare environments.
Crofoot Research Center Goes Digital
While the adoption of the Site Vault Free occurred prior to the pandemic, the benefits of such a system became apparent during this difficult, unfolding health crisis. Charles Sydnor explained that by transitioning all of site file documentation into the Site Vault, that’s helped transform the clinical operations and compliance support within the practice.
While it’s a small research center and not huge discretionary budgets, they’ve been able to streamline processes while fully digitizing clinical trials site-side document management. As TrialSite showcased, SiteVault Free offered in late 2019 a full range of features to Crofoot Research Center, such as a complete, turnkey electronic regulatory document management application for the site, one that supports electronic signature, audit trail, and search functionality necessary for FDA-focused compliance and validation. Importantly, the system also supports secure success for remote patient monitoring, making the site more attractive to other potential sponsors.
Joining a Broader Community
Interestingly, Sydnor shared with TrialSite that Crofoot Research Centers runs nearly twenty clinical trials at any given time, and they work with several prominent sponsors. Although for reasons of confidentiality, TrialSite doesn’t mention the sponsor names here but be assured they are blue chip pharma names, the biggest names in the industry. Much of the pharma industry has adopted the Veeva platform for electronic trial master file and now the vendor expands its reach with other applications from clinical trial management system to electronic data capture, and even a connector technology connecting the pharma eTMF and the site electronic site file (eISF).
Sydnor shared that so many clinical trial sponsor CRAs are familiar with the Vault interface and system; and the fact that the system was robust, fully functional, easily accessible, and a relatively low learning curve made the choice an easy one. Moreover, joining the Veeva community connected the trial site with other sites, CROs and sponsors, a platform for networking, sharing best practices and business development opportunities, all critically important for the smaller independent trial site organization.
The First Veeva eConsent
The pandemic changed everything, and we were certainly glad to have the Site Vault in place, reported Sydnor. Moreover, now with lockdowns and severe restrictions on travel during the first months of the declared emergency, Crofoot Research Center adopted another Veeva tool called Veeva eConsent, a MyVeeva for Patients application built to help streamline the interaction with prospective patients for clinical trials.
Sydnor told TrialSite’s O’Connor that the trial site sought out a cloud-based, secure and compliant application to help patients access initial study information and engage with the site remotely while determining whether the study is appropriate. For the trial site, permissioned staff had real-time visibility into the patient consent process, that is the status, date and related information. All of this data is tracked and monitored in reports so that for any given clinical trial, Crofoot Research Center maintains a centralized digital dashboard of study startup status, tracking patient participation and facilitating the informed consent process.
Just a couple of months ago, Sydnor went on the record, “As one of the first sites using Veeva eConsent, we’re excited to collaborate with Veeva to help the industry shift from paper to digital consent for the benefit of patients and clinical research.” He continued, “Veeva eConsent makes the process easy for our patients and allows us to break down the barriers of paper and location, expanding the reach of our study.”
Not surprisingly, this move to a digital system has helped facilitate a more efficient clinical trials process, making it easier for prospective study participants under semi-lockdown conditions for example, to determine if the particular study was the right one.
Crofoot Research Center continues to work hard at ensuring its historical commitment to maintaining and reinforcing its ties and practice to its community, one that’s deemed vulnerable, underrepresented, and continuously at risk. While the clinic continues its care programs, and the trial site takes on more research, including a large multinational HIV vaccine study, the organization was able to scale up to the next level of operational excellence, using powerful traditionally sponsor-based technology.
Veeva smartly has established itself as a public benefit corporation and continues to leverage the financial returns from the sponsor business to subsidize distribution to trial sites. Crofoot Research Center isn’t done making technology decisions. It must still modernize its clinical trial management and undoubtedly consider offering its patients and subjects ever more digital healthcare options.