Earlier this year, the FDA released draft guidelines for improving diversity and inclusivity in clinical trials to provide a framework for sponsors developing medical products to increase the enrollment of participants representative of the patient population. By encouraging sponsors to pay particular attention to enrollment of ethnic and racial minorities, the desired outcome of the guidelines is to have safety and efficacy results generated within trials that reflect what can be expected from the target treatment population.[1]
Diversity and inclusivity in medical research are important, and yet, clinical trials tend to enroll a population skewed towards White. Participation is not set up to include everyone who needs care. The disparity is even more apparent considering that for any particular disease, minority populations are often disproportionately burdened compared to the general population.
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Based on the 2021 US Census Bureau[2], the US population can be broken down by race as 76% White, 14% Black or African American alone, 6% Asian (including Pacific Islander and Native Hawaiian), and 1% American Indian or Alaskan native. Layering in ethnicity, 19% of the US population is characterized as Hispanic or Latino. In comparison to enrollment in clinical trials, and limiting only to the subset that reports on race and ethnicity from 2010-2020, minority groups are underrepresented across all groups. For American Indian or Alaskan native, 0% were found to participate in this subgroup of trials and multi-race was not captured, with a substantial proportion remaining unknown.
These results are attributable to only providing limited or inconsistent self-identification options collected at trial enrollment, especially when considering that race and ethnicity are separate concepts that often get lumped together. [3]
According to the Alzheimer’s Association, Black Americans and non-White Hispanic Americans are 2 and 1.5 times, respectively, more likely to develop Alzheimer’s disease. Looking at the adult population over the age of 65, this means a Black person has an 18% chance of having AD compared to 10% for a person that is White.[4] Despite the increased risk of developing Alzheimer’s disease, minorities are not participating in medical research to a degree that could be considered representative. In the recent aducanumab trials evaluating the clearance of amyloid plaques, only 19 of 3,268 Alzheimer’s patients or just 0.6% were African American and 104 (3%) were Hispanic.[5] Although this was an unintentional study finding, it does evoke the question of why.
In another example, non-Whites are disproportionately impacted by lupus and the related kidney disease, lupus nephritis (LN). Lupus prevalence among Black patients is several times greater than that of White patients (116.1 vs 34.8 per 100,000 persons). The trend continues for those who progress to end stage renal disease (15.3% Blacks, 4.5% Whites) where the only intervention is routine dialysis or kidney transplant. Not actively planning for diversity in clinical trials can have costly consequences. For example, clinical trials assessing the efficacy of belimumab, a newly approved biologic used in the treatment of LN, did not represent the expected demographic distribution resulting in the opening of a follow on study to assess efficacy within Black patients separately.[6]
Finally, in clinical trials involving patients with multiple sclerosis (MS), 40% do not report data on race or ethnicity. Among the trials that do, over 94% of patients are White.[7] Randomized control trials are conducted on a fraction of patients relative to the number of people living with the disease. Findings in efficacy and safety should generalize to the greater population, however, it is difficult to do when the trials have wide research gaps when it comes to diversity.
A recent publication from the National Academy of Sciences highlights several considerations that should inspire us to pay attention and take strides towards a course correction in inclusion of ethnic and racial minorities in medical research.[8]
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Site based studies mean that participants must live within a commutable distance or travel to sites for treatments, monitoring, and follow up care on the frequency defined within the trial protocol. This may present an extra challenge for minority patients who can’t absorb the financial implications of participation due to socioeconomic factors including travel, missed days of work, or finding child care while they are away.
The trials themselves often include criteria that directly excludes minority patients from participation. For example, a study of trial criteria found that many had language and educational requirements, or required caregivers to be present at all appointments. These are obvious barriers to participation in trials. More subtly are exclusion of participants with comorbidities including being diabetic or having BMI outside a particular range. While seemingly innocuous, these criteria disproportionately impact minority participants that are more likely to have these conditions.[9]
For good reason, distrust in the medical research community is deep-rooted in many minority populations due to historical racism within clinical trials and universally throughout the healthcare system.[9,10]
Decentralized, patient-centric models give patients living in rural areas or away from centers of excellence equal opportunity to engage in research without requiring travel, time away from work, or constraints on childcare that have historically been barriers to trial access and participation. As an example, PicnicHealth is geographically neutral, meaning that patients enroll from all 50 states and any community, holding to the general principle that real-world approaches can meet patients where they are. Data can be collected digitally and assembled from a number of data sources including electronic health records, claims databases, and surveys collected directly from patients. Removing geographical boundaries and financial burdens, real-world data studies encourage participation by a more representative and diverse group of patients. Using a decentralized approach, PicnicHealth has built a real-world MS cohort. As shown below, this cohort includes 17% Black or African American patients while traditional randomized control trials were found to enroll only 2%.
Real-world data collection can also provide a more comprehensive view of the patient because participants with rich and complex medical histories are not excluded from research. Patients enrolled into a PicnicHealth cohort are followed through their medical journeys and data is collected across a full spectrum of care providers. Data collection is not limited to medical care associated with a single primary condition, comorbidity, insurance provider, or care network. Where traditional trials might exclude participation due to a host of criteria like age, vaccination status, blood pressure range, recent surgeries, BMI, pregnancy status, or previous therapies, real-world data does not.
Real-world data collection appreciates the diversity of patients providing an equal opportunity for participation in research and can fill in gaps that would otherwise be lost in trials with stringent exclusion criteria.
Gaining patient’s trust in a medical system that has historically neglected or unethically depended on ethnic and racial minorities will take time. Real-world data collection can help identify discrepancies between real world patient care and care received through a controlled trial environment. Mandated plans to improve diversity within the clinical trial setting may speed up the process, but are unlikely to solve the problem overnight. By offering study participation in a low cost and low time commitment real world study, participants of all backgrounds can contribute to research. Providing feedback on how their data contributes to changes in care or particular study outcomes can help establish a positive relationship with the medical community and research on human subjects.
Pharma can step up to the diversity and inclusivity challenge by partnering with RWD companies like PicnicHealth. Offering real-world datasets in Alzheimer’s Disease, lupus nephritis, multiple sclerosis, and many more conditions, PicnicHealth is delivering representative data.
Reach out for more information about data solutions in your therapeutic area at partnerships@picnichealth.com.
patients onboarded to platform
medical visits processed
facilities provided medical records
healthcare providers
research programs
published posters and manuscripts
partnerships with top 30 pharma
Discover how PicnicHealth data powered medical research in 2021
New methods to improve the identification of lupus nephritis patients in RWD using narrative text extraction were presented at the American College of Rheumatology Convergence virtual conference.
Ultragenyx and PicnicHealth presented preliminary data at the International Network for Fatty Acid Oxidation Research and Management (INFORM) LC-FAOD conference, showcasing the power of linking medical records to patient reported outcomes to better understand the complexities in LC-FAOD care.
We joined Roche-Genentech and other key researchers to introduce a longitudinal, patient-centric Hemophilia A real-world dataset that features abstraction of data points from medical records at scale and supplementation with patient-reported outcomes at the American Society of Hematology annual meeting.
Also at ASH 2021, Roche-Genentech and our research partners presented new findings looking specifically at mild and moderate hemophilia A patients found in PicnicHealth’s RWD cohort to better understand disease burden and healthcare resource utilization in this historically underrepresented patient group.
This year, experts from PicnicHealth joined podcasts, webisodes, virtual summits and much more to speak to the importance of patient-centric approaches when building complete, deep real-world datasets.
CMO Dan Drozd joined The Evidence Base to discuss how to build and measure data completeness
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BBC Storyworks and Roche featured Noga Leviner and her medical journey in “The power of partnerships”
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CEO and Co-founder Noga Leviner joined our partners Komodo Health to discuss patient-centric RWD in “For the Health of It”
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PicnicHealth experts joined Arsenal Advisors in 3 summits to highlight our research partnerships
(from 13 patients with LC-FAOD)
38% Female
15 providers / patient
7.5 years of data / patient
(from 13 patients with LC-FAOD)
patients onboarded across 19 conditions
medical visits processed
healthcare providers
Facilities provided medical records
Change Champions onboarded
Research programs
published posters and manuscripts
partnerships with top 30 pharma
At ASH 2022, Genentech, a member of the Roche group, and our research partners presented their study examining the epidemiology and bleeding phenotype in females with mild Hemophilia A (HA), a minority group that is poorly characterized, compared with a cohort of males with mild HA.
At EHA 2022, Novartis used PicnicHealth’s real-world data to characterize sickle cell disease and burden of illness in the United States.
Genentech leveraged the FlywheelMS cohort to describe COVID-19 vaccination patterns and COVID-19 outcomes among people with multiple sclerosis (pwMS) and in subgroups of pwMS, including by disease-modifying therapy (DMT) status.
We partnered with Alexion, AstraZeneca Rare Disease to help identify flares in Lupus Nephritis patients by combining structured and unstructured medical records with lab data.
Cohort Overview. Understand patient healthcare utilization throughout disease history with ability to probe for meaningful mentions and events.
Sickle cell (SC) is the most common inherited blood disorder in the United States. Red blood cells become rigid and shaped like crescent moons, preventing oxygen from getting to parts of the body. This can cause fatigue, severe pain, organ damage or stroke.
Addition of Narrative Text Abstraction to ICD-Based Abstraction Significantly ImprovesIdentification of Lupus Nephritis in Real-World Data
Join our early breast cancer registry to be counted and share your story with research.
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List the names of all the doctors, hospitals, and other facilities your loved one visits regularly, along with those they have visited in the past. Try to go back as far as you can, striving for at least the last 5-10 years, but do your best. Even if you can’t remember them all, having a strong baseline can help you quickly identify gaps in records.
It is important to make sure that you are fully empowered to make decisions on behalf of your loved one with Alzheimer’s. Your relationship status with the patient may not be enough to legally give you access to your loved one's medical information. It is a good idea to talk to an expert about securing special legal status, such as Power of Attorney (POA), a legal document that allows an individual to name someone as their decision maker should they no longer be able to make decisions on their own.
It’s important to have all of your loved one’s medical records together in one spot. This makes it much easier for you and your loved one’s physicians to accurately map the patient’s medical journey and more easily share information between doctors. Fortunately, tools exist to make record management and access simple. A free resource like PicnicHealth helps you collect and organize all of this information. PicnicHealth’s intuitive timeline allows you to pinpoint data across the medical history, eliminating your need for keeping heavy binders filled with paper records or keeping track of multiple software portal logins.
The better you understand your loved one's medical history, the better you can advocate on their behalf. Access and understanding of this information will help you to ask informed questions with physicians. Through regular communication backed by the data in the medical records, you can help your loved one’s care team develop a more successful care plan.
Learn more about PicnicHealth’s commitment to the Alzheimer’s community and the Alzheimer’s Association
Learn MoreWhen you’re juggling appointment times and insurance claims, putting a robust support system together might not strike you as the most urgent task. Investing the time to cultivate relationships with people can turn to in times of need will pay dividends. The next time you need a last-minute ride or just someone to listen, you won’t be on your own.
There are many condition-specific support groups and support groups for caregivers generally in person or online. In addition to the encouragement and empathy they provide, support groups can be a helpful source of tips, resources, and recommendations for navigating caregiving.
The backbone of effective caregiving is organization. Keep medical information, appointment schedules, and medication lists in order. Use a planner or a digital service like PicnicHealth to stay on top of your responsibilities. This attention to detail can prevent future complications and reduce day-to-day stress.
We’ve seen incredible breakthroughs in treatment over the past couple of years, powered by patients and their caregivers participating in research. Stay in the loop about the latest in medical advancements and available resources that could benefit your loved one. Whether it’s a new therapy option or a community service that aids independence, being informed can make a world of difference in the quality of care you provide.
It may seem self-centered to focus on self-care—but when you feel good, you can be a better caregiver. Whether it’s exercise, a mindfulness practice, a soak in the bath, or just time to rest when you need it, carve out those moments in the day when you can unwind, reset, and stay healthy mentally and physically. Think of it as building up your reserves of kindness, patience, and understanding—which can only benefit your loved one. No one can pour from an empty cup.
Easily manage all of your loved one's medical records and contribute to ongoing Alzheimer's research with PicnicHealth.
Learn More(from 13 patients with LC-FAOD)
38% Female
15 providers / patient
7.5 years of data / patient
(from 13 patients with LC-FAOD)
We hope you found this session informative! Sign up for PicnicHealth’s Alzheimer’s research program below.
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