Clinical trials have historically lacked representation from diverse ethnic and racial groups, while also lacking diversity in gender and age. Clinical trial populations are often not proportionate to the populations that are affected by the disease. Recent studies have shed light on the lack of diversity in clinical research. One example can be found in gender representation. Women and specifically women of color have historically been underrepresented in clinical trials. A recent Northwestern Medicine study analyzed over 20,000 clinical trials between 2000 and 2020 and found that women are underrepresented in clinical trials in cardiology, oncology, neurology, immunology and hematology. This stat is particularly troubling given that cardiologic and oncologic diseases are among the leading causes of death among women in the United States.
Minorities are also vastly underrepresented in clinical research. A 2019 article in JAMA Oncology highlighting the disparities in race reporting and diversity in clinical trials in oncology found that on average, 76% of trial participants were white, 18% Black, 3% Asian and 6% Hispanic. Even more striking, a recent analysis of Alzheimer’s trials found that while Black people are more prone than White people to develop Alzheimer’s disease, they represent only 2% of those included in clinical trials.
Adequate representation is critical in clinical research for various reasons. First, disparities in access to clinical trials prevent minorities from benefiting from advances in science. Additionally, lack of adequate trial diversity can result in trial outcomes that are less applicable to the entire population. Further, therapies can have different efficacy and safety effects in different subpopulations. Therefore, lack of diversity in clinical trials may fail to assess racial differences that affect clinical outcomes. Diversity in trials is needed to promote equitable access to healthcare and to improve outcomes by making trial populations better reflect the population across various racial, ethnic, gender and age groups. However, historically, no clinical trial site network platforms have specifically focused on diversity and increasing representation of minority groups.
Solution
Alcanza, which means reach in Spanish, is focused on targeting diverse clinical trial participants and underserved markets to improve equitable representation in the clinical research space. Alcanza Clinical Research is a multi-site, multi-phase clinical research platform with locations currently in Massachusetts, New Hampshire, Michigan and South Carolina. The company has established a presence across Phase I-IV studies and various therapeutic areas, including Neurology, Dermatology, Psychiatry and Vaccine. This is a roll-up strategy in which Martis Capital formed Alcanza upon the acquisition of three initial sites, has since acquired a fourth site and intends to continue to grow both organically and via acquisition of additional sites. By leveraging its national footprint, best-in-class systems, standard operating procedures and deep sponsor relationships, Alcanza is positioned to become a market-leading platform in a highly fragmented space of more than 2,500 independent research sites.
Why We Invested
Minorities continue to be under-represented in clinical trials. However, racial, gender and age diversity is critical in ensuring the equality, validity, and scientific rigor of clinical research. While the issue is beginning to gain wider acceptance, scientific research still suffers from a severe lack of representation across all therapeutic areas. Recently, the FDA and pharmaceutical sponsors have called for greater trial diversity that better resembles the overall population. Further, lack of patient recruitment diversity can slow the drug development process, as evidenced recently by the Moderna COVID vaccine clinical trial. However, while the FDA has called for greater representation in clinical trials, no specific regulations have been enacted. Given the FDA and society’s push for pharmaceutical corporations to implement adequate patient diversity in clinical research combined with the fact that there is no existing market leader in the space, clinical trial site networks such asAlcanzaare well positioned to differentiate themselves by driving recruitment of minority populations. A scaled clinical trial platform such asAlcanzawill have the integrated systems and capabilities to run larger and more complex trials with diverse patient populations, thereby advancing innovative treatments through the various clinical trial stages.
The Alcanza team has extensive experience in the clinical research space and integrating sites. More importantly, the team has an explicit focus on the patient experience and recruiting diverse patient populations; diversity in clinical trial participants is core to the Alcanza team’s mission. Specifically, CEO Carlos Orantes has over 25 years of experience in the drug development industry. Carlos previously led a leading site network brand and oversaw over 50 clinical trial sites. He has direct expertise integrating sites into a broader platform and brings with him a depth of industry relationships and clinical trial expertise. Further, Alcanza’s leadership and the lead investor, Martis Capital, are working closely together in further professionalizing the Alcanza platform. More recently, the Martis Capital and Alcanza teams have developed a true partnership, working together to launch the Alcanza platform and develop the core business strategy. The Martis Capital and Alcanza teams share a similar mission to build a leading clinical trial site network that is committed to increasing representation in the clinical trial space.
Impact
We believe that Alcanza can not only increase representation for minority groups in the clinical trials that it manages, but also has the potential to serve as a market leader in this space and help to change the way the industry approaches diversity in clinical trials. Central to our investment thesis is the fact that Alcanza aims to increase representation for underrepresented groups in clinical research. However, recruiting and retaining diverse populations into clinical trials is not always straightforward as specific subpopulations may be hesitant to enroll in clinical trials, may lack the means of adhering to the trial requirements and may be uneducated as to how their involvement in trials may impact their own health as well as contribute to broader scientific research. Therefore, there is a high level of engagement required by Alcanza in order to educate and engage diverse populations. We are confident that Alcanza has the expertise and the commitment to address this issue. Alcanza has brought on a well-regarded industry expert to serve as the Chief Patient Experience Officer, a leadership role unique to Alcanza within the industry, which further solidifies Alcanza’s focus on this issue. Alcanza intends to specifically focus on aspects related to community and patient engagement in order to successfully recruit and retain diverse trial participants.