The Goes Direct program works to form partnerships with area providers and other regional people to connect with a broader patient population. It uses the company’s IntElligo Research Stack, which aids recruitment by searching electronic health records for practices frequented by patients that fit certain study criteria. It then facilitates automatic preparation of data for submission and regulatory compliance.
At The Center for Women’s Health in Colorado, Elligo worked with healthcare leaders to increase women’s clinical trial access. Elligo also maintains approximately 50 women’s health-focused research sites and plans to add more. According to the company, its size makes it the largest women’s health network in the world.
Additionally, Elligo recently partnered worked with doctors and healthcare providers at a center in El Paso, Texas, to inform the largely Latino community of available research and treatment options. The outreach effort was profiled in a documentary.
John Potthoff (JP), CEO of Elligo, talked with Outsourcing-Pharma (OSP) about the importance of increasing the diversity of patient populations in clinical trials, and how his company is working to SOMETHING.
OSP: What’s your perspective on why diversity in patient populations is important?
JP: Different populations, such as races and age groups, respond differently to medications and treatments. This is something that the medical community knows, but within traditional research protocols, sites may not account for. That means they’re usually using 'cookie cutter' patients (typically white males). Addressing this by including a large, typically underrepresented population that is concentrated in one area, like the Latino community in El Paso, helps ensure research is being inclusive.
OSP: What are some of the areas in which sites frequently miss the boat regarding diversity in patient populations?
JP: Ethnicity, gender, and genetic background. Within those three areas, non-white ethnicity, non-male gender, and non-European genetic background are the largest examples of patient populations most often underrepresented in traditional sites.
OSP: Are there any other patient population demographics that clinical trial managers are even less likely to think about?
JP: Both economic status and age are important patient population characteristics. They are probably close to front of mind when we say “diversity.” However, other areas which should be considered are:
- Socioeconomic: This is more nuanced than simple economic status. Discrepancies in sociocultural status, combined with income considerations, can significantly affect a person’s ability to travel, take time off from work, etc. They may not have the same opportunities or receive the same level of outreach encouraging them to participate or engage.
- Geographic: Regionally, it’s easier for those in larger metro areas to access academic and other primary research centers. Being able to target community practices that are typically not considered due to their location is another way to incorporate a diverse PP. Also, those in specific areas of the country can be exposed to different diseases, and therefore respond differently to treatments.
- Pediatric/geriatric: More specific than considering age in general, those on both ends of the age spectrum are typically overlooked due to their dependence upon others to help them schedule treatment visits, obtain transportation to research centers, and adhere to a protocol.
OSP: How have efforts to increase patient population diversity evolved in recent years?
JP: Innovations in healthcare technology — specifically as it enables access to patient data in a localized way — has helped more accurately project patient populations and created new ways to reach patients who might participate in trials. These innovations have also helped with patient engagement. For some of the areas of diversity that have not been as frequently considered — such as geographic or regarding a particularly hard-to-reach socioeconomic group — wearable tech and shipping organizations that allow patients to stay at home and still participate have helped bridge gaps.
However, the overall narrative needs to change in order for sites to step away from the 'traditional' way of doing research.
OSP: Can you share an instance in which failure to attract an adequately diverse patient may have led to a negative patient outcome when a particular treatment was launched?
JP: A lot of the differences in response to drugs and the potential for adverse events, side effects has to do with pharmacogenetics. Differences in pathway/enzymes for metabolizing drugs result in poor or ultra-extensive metabolizers for different drugs lead, which leads to higher incidence and severity of side effects for different groups.
Examples of varied effects of drugs with different racial/ethnic groups:
- Differences in genetic variations associated with different levels of response to asthma medication class of beta-agonists – so fewer Hispanics may respond well to albuterol compared to Caucasians
- Asians vs Whites for some antidepressants/antipsychotics (Clomipramine, Clozapine, Haldol)
- Differences in therapeutic effect of antihypertensive drugs for African American and White hypertensive patients (ACE inhibitors, Angiotensin II receptor blockers, Hydralazine)
- Hispanic population has a different response to asthma
- The analgesic effect of morphine metabolized from codeine is lower in Chinese vs Caucasians
- Reduced ability to convert clopidogrel to its active form for poor metabolizers thus remaining at increased risk for MI and stroke – Pacific Islanders
OSP: Could you please talk a little bit about how Elligo Health Research brought about solutions, for example, in the El Paso community?
JP: The Medical Center of the Americas (MCA) serves innovative trials to patients who may be uninsured or under-insured. Patients were unsure, or unaware, of research opportunities unaffiliated with their trusted physicians. There is a large population of immigrants and/or first-generation residents, so not having to leave the comfort of their own doctors’ practices made a big difference. Also, having their medical history already on file was important and helped with engagement. The cost of trial participation was a large factor in the El Paso community. Not only was there little research being conducted in the local area, but the population also is largely working class/shift/contract workers for whom paid vacation days may not be available. The availability of local research, conducted flexibly around their schedule, was a major factor in recruitment.
OSP: Why is it important for clinical trial sites and managers to work with community physicians?
JP: By enabling patients to visit their trusted personal physician to participate in a clinical trial, you’re providing them with access to a more comfortable, more familiar process, relationship, and environment. By providing access to these, you are able to offer state-of-the-art research as a care option to largely overlooked and underserved populations. An additional advantage of having this model established in communities is that it brings in new physicians who are excited about the opportunity to participate in such research.