Houston, a vast and sprawling but certainly dynamic place also happens to be America’s fourth largest city known as an international hub of medicine and energy, and represents an important hub in the war on COVID-19. Thus a Houston research firm, actually part of a sizeable network of clinical investigator sites conceived and built by a successful clinical research site entrepreneur named Mohammad Millwalla, was selected by major vaccine sponsors to participate in COVID-19 vaccine clinical trials as recently showcased by local media. At least one major sponsor, the BioNTech and Pfizer partnership, selected the Texas Center for Drug Development and DM Clinical Research to capitalize on the group’s access to a diverse pool of patients in this immense metropolitan region and beyond, in addition to their deep expertise and experience in conducting research site operations. Access to an ethnically diverse participant population for vaccine and drug development sponsors is of paramount importance and Houston represents a compelling choice for this research imperative. Mr. Millwalla has developed the largest privately-owned investigative network in Houston and a sizeable network of investigative sites in Texas, Louisiana, and Illinois.
Participation Key for Vaccine Trials
With reports that at least in some locations, finding volunteers to participate in COVID-19 vaccine trials could be challenging, Dr. Vicki Miller was recently quoted on local media KHOU-11: “We do want more people who are high risk, such as healthcare workers, firefighters, essential workers, people who work in grocery stores, but we do have vaccines for all different risk levels.”
Vaccine Research in America: Participant Diversity Important
Dr. Miller emphasized the importance of diversity in clinical trials such as vaccine research. Houston’s diversity is one of the reasons why this area and site was selected. Miller commented, “In order for trials to be shown effective and safe in all populations, all different types of people, all genders, races need to participate.” But this has been a challenge traditionally in research as underserved, underrepresented groups such as ethnic minorities, from African Americans to Hispanic/Latino and certain Asian populations or certain Anglo populations are harder to reach for research purposes.
Houston: a Diverse Place
Houston is America’s 4th largest city with about 2.3 million in the city and 7 million in the metropolitan area. One of America’s international cities, in part due to its concentration of academic institutions and strong biomedical, energy, manufacturing and aerospace industries, Houston’s population is one of the most diverse of big cities with 25.3% African America, 37% Hispanic/Latino and 5.3% Asian. If a clinical trial sponsor seeks a diverse region for volunteer or patient participation, Houston should be considered. With over a half million African Americans, the City of Houston has the fourth largest black population in the United States. For those interested in some of the underlying factors and forces behind clinical trial participation challenges see the TrialSite News African American Survey (coincidentally undertaken in Southeast Texas in the City of Beaumont and online) on why African Americans don’t participate in research.
From the recent local KHOU-11 broadcast, the research site may be representing multiple vaccine sponsors. TrialSite News has confirmed that the Texas Center for Drug Development is in fact a selected site in clinical trial NCT04368728 sponsored by Pfizer and BioNTech, a multi-site, Phase 1/2 , 2 part dos-escalation trial investigating the safety and immunogenicity of four prophylactic COVID-19 RNA vaccines using various dosing regimens. The investigational vaccine candidate is known as BNT162.
The Research Site
The Texas Center for Drug Development is a large, multi-specialty clinical research organization with over 12,500 square feet of dedicated research space divided into three separate clinical research sites in the professional building for the Medical Center of Bellaire, in Houston.
This organization consists of a large group of experienced doctors and staff including 5 Principal Investigators, 6 Sub-Investigators, 12 clinical research coordinators (5 of whom are foreign medical graduates with MD degree), and separate departments for regulatory, quality assurance, data entry and finance.
Patient recruitment capability is a critical function for a high performance research site operation. This group in Houston appears to understand this and has developed a five-person recruitment team, responsible for buying local media time to promote studies, hosting health fairs, and conducting community outreach as well as working with local physicians for referrals. The group understands that transportation can be a challenge, especially in a sprawling metropolis such as Houston and have invested in a patient shuttle and full-time driver. For more capabilities associated with this site, follow the link.
According to the company’s website, they have three research-only databases, made up exclusively of previous study volunteers. Their research databases are divided into a 15,000 subject internal medicine databases, a 4,000 patient psychiatric database and a 3,000 person healthy volunteer database for vaccine and Phase 1 studies—it is this latter database of course that will undoubtedly be utilized for the BioNTech/Pfizer COVID-19 vaccine study.
DM Clinical Research Connection: the CEO
The local news reported the joint effort with both the Texas Center for Drug Development and DM Clinical Research. They are both owned, as mentioned previously, by Mohammad Millwalla. This healthcare entrepreneur saw the potential in health research nearly two decades ago and is a Certified Clinical Research Professional (CCRP). According to their website, DM Clinical Research is a network of investigator sites in Texas, Louisiana, and Illinois, and the largest privately owned investigative network in the Houston area.
According to their website, they operate in partnership with the Texas Center for Drug Development and focus on linking pharmaceutical sponsors and research organizations to caring individuals seeking to power the advancement of medicine. By working with qualified physicians with a diverse range of specialties (e.g. cardiology, endocrinology, pediatrics, rheumatology, etc.), they have conducted a wide variety of studies with successful enrollment targets. They understand the importance of highly educated, well trained coordinators.
Houston Fights COVID-19
The Texas Center for Drug Development and DM Clinical Research partnership has developed a website to educate local Houstonians about the COVID-19 pandemic and clinical research. Titled “Houston Fights Covid,” the website was developed to inform members of the public as to the pandemic, the importance of research and, of course, of participation. It is actually part of a community education campaign that must be implemented to support major research studies.
Call to Action: If you reside in the Houston area and want to contribute to fighting COVID-19 by helping research then check out Houston Fights Covid to learn more.