Private equity-backed site organization roll-up Velocity Clinical Research purchased eStudySite, contributing two trial site locations in San Diego, California to its North American site portfolio, now totaling 14 sites. Located in both La Mesa and Chula Vista, Velocity Clinical Research now operates in traditionally ethnic minority neighborhoods in Southern California. An important move as the march to precision medicine demands more trial diversity. TrialSite recently reported that the North Carolina-backed trial site organization’s status among sponsors was rising due to its participation in most COVID-19 vaccine trials. COVID-19 is devastating many communities, particularly those in lower-income and diverse communities, and the research enterprise must be present in such neighborhoods and districts for successful engagement ongoing.
Velocity Clinical Research, founded in 2017, continues to make considerable moves to establish itself as a major trial site organizational player in North American research. The pedigree and connections of its CEO and President, Dr. Paul Evans and his management have led to significant contracts with major pharmaceutical trial sponsors. Now comes delivery time as the group has commitments to enroll 20,000 volunteers across 10 of its existing sites. Big pharma brings what can be lucrative return business to those sites that can deliver on a continual basis. With the COVID-19 pandemic, the stakes could never be bigger, and the sponsors are carefully monitoring which trial sites are performing.
Enrolling minority patients in clinical research represents a significant challenge that is overcome by foundational commitments, provider and community networks and practices that work with, and are trusted in diverse demographic environments. The underlying trust necessary for such practice cannot be purchased but rather, represents the yield form directed investment and action over time. Medical practices and study sites that have developed deep ties into diverse communities are very valuable for the research enterprise for a number of reasons including the move to precision medicine to the need for representative testing of novel therapies during a pandemic such as now.
COVID-19 thus far has hit minority groups hard in the United States. APM Research Lab analyzed COVID-19 cumulative per 100,000 people death rates by ethnicity or race. Blacks and Native Americans are dying at nearly twice the rate as various white (European) ethnic groups for example. The COVID-19 mortality rate for African Americans stands now at 114.3 with Indigenous Americans at 108.3. White Americans’ COVID-19 mortality rate now equals 50.5: interestingly, Asian Americans have a slightly lower mortality rate than whites at 61.7. Hispanic (Latino) cumulative mortality rates to date equal 78.5
The data are clear that African Americans and Native Americans (Indigenous) are dying at almost twice the rates as of whites. Hispanics are at greater risk and although its’ not included in this analysis, an economic cohort analysis would probably reveal that the Hispanic (and all other) death rates may be higher in poorer neighborhoods due to social determinants of health (SDoH).
Velocity Acquisitions to Diversity
The dynamics described in the preceding section point to the rationale for the Velocity Clinical Research move into heavily Hispanic Southern California. Approaching 1.5 million in the city alone, San Diego represents the 8th largest American city by population. And it’s a diverse place: About 25 percent Hispanic, the city’s Asian population totals 16% and its African American population now stands at just under 7%.
Like most major American cities, San Diego represents extremes demographically, socially and economically. Generally, wealthy enclaves exist in northwestern coastal areas near University of California, San Diego in La Jolla, for example. There, communities tend to range from middle class to extreme wealth and are overwhelmingly populated by whites and considerable Asian populations. While the farther one travels east of downtown or south, toward the Mexican border, the more traditionally working class and Hispanic the city becomes, with pockets of African American and Asian enclaves including Fillipinos and Pacific Islanders (e.g. Samoans, Tongans).
eStudySite operates in both La Mesa and Chula Vista, which represent diverse parts of the county southeast and south of downtown. For example, La Mesa, with about 60,000 residents, is actually part of San Diego County and lies to the east of downtown. About 22 percent of its residents are of Hispanic origin, 8 percent African American and about 6 percent Asian.
The Chula Vista site sits in a separate city just south of downtown San Diego and its more traditional African American enclave known as National City. Approaching 300,000 residents, Chula Vista’s population is largely Hispanic at about 60 percent.
Now these sites are already embedded in the community and enrolling volunteers into COVID-19 vaccine studies according to Clinical Research Velocity’s most recent press release. According to CEO Dr. Evans, “Velocity has been aggressively expanding both its site portfolio and therapeutic ability since we launched three years ago. This acquisition is strategic for two reasons. Firstly, these sites are important for recruiting volunteers from minority communities and secondly, we anticipate a resurgence in the infectious disease areas.”
eStudySite declares on its website that it is actually an elite site in terms of patient enrollment representing, consistently, the top 5 percent of all participating trial sites for paid clinical trials involving NAFLD, NASH, MRSA, pain, sepsis, community-acquired pneumonia, hospital-acquired pneumonia, diabetes, dermatology, vaccines, CV, influenza, and others.
Founded by William O’Riordan, MD in 1999 along with twelve healthcare providers, Dr. O’Riordan was extensively involved with emergency medicine at St. Francis Medical Center, Paradise Valley General Hospital and Sharp Chula Vista Medical Center for over three decades. With impeccable academic and clinical credentials and pedigree, Dr. O’Riordan leveraged his connections, knowledge and expertise in medicine, not to mention the provider and specialist networks, to found the research site. Over two decades later, it now becomes part of an evolving new model for research.
Current CEO Dave McCarthy recently commented, “We believe that Velocity has the right people and experience to help evolve the clinical trial landscape and that’s why we are delighted to become part of the group. eSS shares Velocity’s vision of providing the infrastructure to speed up and standardize data collection during trials in order that drugs and vaccines are approved quicker.”
With Phase 1 study capability, the team at eStudySite have spent over two decades developing a high quality and patient-centric culture: an important element for any Phase 1 trial site caring for overnight volunteers. For a description, see the link.
Velocity Clinical Research Coverage
As TrialSite has explained in past articles, Velocity Clinical Research almost starts to look like a contract research organization in terms of aspirational size, sophistication and capability as the company leverages debt financing arranged by private equity firm Navimed to carefully and strategically expand across the United States. With the latest deals, this emerging “super site” organization can enroll patients in eight states including Ohio, Florida, California, Texas, Rhode Island, Utah, Idaho, and Oregon. Operation Warp Speed also keeps the firm incredibly busy based on the demands of the pandemic and the pivotal vaccine trials.
J Scott Overcash, MD, Clinical Medical Officer, Medical Director La Mesa, Principal Investigator
Michael Waters, MD, Medical Director, Chula Vista, Principal Investigator