How The All of Us Research is Restoring Trust and Bringing A Much-Needed Diversity to Medical Research

Did you know that the majority of research studies conducted in the United States are predominantly based on groups of white male participants? Color me unsurprised. While this fact is definitely worthy of an eye roll, it also has serious implications for the effectiveness of treatments and medications given to people from all walks of life who don’t necessarily fit the mold.

The All of Us Research Program was launched in May 2018 with the goal of tailoring medical care to the needs of the individual. Funded by the U.S. government through the National Institutes of Health (NIH), the study aims to gather data from Americans of all backgrounds in order to provide a hub for future research acknowledging the different factors that influence individual health.

A large, government-funded research study that seeks to collect data from a million Americans by 2020 could be cause for suspicion among members of black communities, who have a well-founded historical distrust of the medical system. We’ve turned to Dr. Edith Mitchell, professor of medical oncology at Thomas Jefferson University and a National Medical Association board member, for insight into the program.

Radiant Health: What is the goal of the All of Us Research Program?

Dr. Edith Mitchell: There has never been a study like the All of Us Research Program conducted in the U.S. or by the National Institutes of Health. This program is needed, because when you look at medical research, many studies now are being designed according to precision medicine. What that means is that there is no one-shoe-fits-all approach to disease. This is really a way of expanding precision medicine, in that the research and the healthcare delivery that will be developed based on this study will be designed and based on the individual patient.

We’re using precision medicine to find out a lot about disease processes and the contributing factors to development of disease. Some of the individuals in the program will be healthy, because we’re also looking to identify some of the contributors to the development of disease processes. That includes environmental exposure, family history, other risk factors, and (one of the most important areas to evaluate) the social determinants of health.

Overall, the study is about discovering through precision medicine some options for not only providers, but their patients. In the future, it’ll be about providing a public resource that already has volunteers, infrastructure, and data management, such that researchers can use this information for developing medical breakthroughs and new treatments.

It is also unique in that we intend to include individuals from all aspects of life in the U.S. We intend to include over one million healthy and ill participants of all races, ethnicities, gender presentations, health status, and other social determinants of disease.

RH: What are the benefits of participating in the All of Us Research Program?

Dr. Mitchell: You have access to your data. For example, if you’re found with a specific risk factor, you’ll have access to the data and be able to discuss it with your physician. Knowledge is power, and for participants there’s power in knowing your risk factors, accessing your data, and potentially changing your lifestyle, diagnostic services, or treatment parameters.

Another advantage is that there can be cumulative data. The study is designed to help not only the participants, but others who may be of similar circumstances, with similar social determinants of health.

If there’s found to be a unique genomic profile found in any racial or ethnic group (for example, diabetes is very common among African Americans), if we find there’s a unique risk picked up on the genomic profiling, this might help not only the individual, but others that might have similar genomic history.

It will help researchers in that they may be able to collect more data from this study as opposed to trying to collect from individuals in their own lab or research area.

RH: What steps are being taken to protect data?

Dr. Mitchell: We have some of the greatest individuals in information technology and digital health in the nation. We’re working with those organizations to protect the data and have continuous monitoring using some of the greatest techniques in the country. We also removed all identifiers, and the data is encrypted and stored on a secure platform. There’s no 100% guarantee that any security data system is totally secure, but there’s every effort available being used for the protection of participant information.

RH: How are you reaching out to African Americans and African immigrants, and why should this community care about the project?

Dr. Mitchell: It will be relevant to not only African Americans and other minorities underrepresented in previously conducted clinical trials, but it will include all individuals in the U.S., as long as they’re 18 or over and have the ability to sign informed consent. Later, we also intend to include children.

We collaborate and work with community groups, and through community engagement throughout the U.S. we’re reaching all populations. At this time, we already have over 200,000 who have signed consent and are participants in the All of Us program. More than half of that number are from minority or underrepresented ethnic groups. Patients and individuals will have access to their information, can withdraw consent at any time, and their information is highly confidential and protected through the electronic mechanisms that we have.

RH: Have you experienced any challenges in reaching out to minority communities?

Dr. Mitchell: We’ve had absolutely no difficulties. We’re collaborating with churches and community organizations such as the National Hispanic Medical Association and the National Medical Association. The latter was formed in 1895, when black doctors in this country were denied membership in other organizations. We’ve also worked with, among other community groups, African American sororities, who have memberships consisting of more than 100,000 women for each of the groups.

RH: What would you say to a black woman hesitant to join because of a distrust in the medical system?

Dr. Mitchell: We try to address that before we even go into a community to recruit or give educational programs. Interestingly, I’ve given these programs around the country, and in most situations, I have not had anyone after my lecture indicate that they’re afraid or would not participate. In most cases, they’re asking how they can participate, and for more information and opportunities for access.

We really have had success. The program just opened May 6, 2018. We’re not more than a year out and we have 200,000 participants. By collaborating through community engagement, where we don’t just go and give a lecture, we’re already working with various community organizations and people in those communities. I’ve given the lectures to sexual and gender minorities, black and African American audiences, Hispanic audiences—but I don’t do it all by myself; we’re already working with collaborators.

RH: Is the project targeting any diseases that particularly affect our community?

Dr. Mitchell: We’re targeting most of the common diseases and some rare diseases, in addition to healthy individuals who might not have signs or symptoms of any disease at this time, to find out what their risk factors might be and what kind of social determinants of health they might identify with.

RH: What are the next steps for the All of Us program?

Dr. Mitchell: At this time, our efforts are focused toward reaching populations to make sure this research applies to the individual. Later (and we actually plan to start sometime this year) there will be an opportunity for researchers to participate by using some of the data, without access to any identification parameters, to do research on specific disease processes or prevention.

The All of Us program could be a tremendously important tool in allowing researchers to halt the disease process, helping people in this country to live longer, more exciting, and healthier lives.

To learn more about the All of Us Research Program and how to participate, visit the program website.