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Diversity in Medical Research Matters

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 by the numbers: how does the industry stack up?

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.  

Figure 1: Comparison of US population and trial participation by race and ethnicity

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]

Alzheimer's Disease

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. 

Lupus Nephritis

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]

Multiple Sclerosis

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.

What do we stand to lose?

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]

Figure 2: Consequences of limited diversity in medical research

Roadblocks on the Path to Diversity

Geographical barriers

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.

Clinical Trial Inclusion and Exclusion criteria

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]

Distrust of Research Community

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]

Real-World Data breaks down participation barriers

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%.

Figure 3. Comparison of PicnicHealth’s real-world MS cohort to traditional trials

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 [email protected]

References

  1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations
  2. https://www.census.gov/quickfacts/fact/table/US/PST045221
  3. Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am. 2022 Jul;11:100252. 
  4. 2021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23. PMID: 33756057.
  5. Lin GA, Whittington MD, Synnott PG, McKenna A, Campbell J, Pearson SD, Rind DM. Aducanumab for Alzheimer’s Disease: Effectiveness and Value; Final Evidence Report and Meeting Summary. Institute for Clinical and Economic Review, August 5, 2021.
  6. Ginzler E, Guedes Barbosa LS, D'Cruz D, Furie R, Maksimowicz-McKinnon K, Oates J, Santiago MB, Saxena A, Sheikh S, Bass DL, Burriss SW, Gilbride JA, Groark JG, Miller M, Pierce A, Roth DA, Ji B. Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2022 Jan;74(1):112-123.
  7. Onuorah HM, Charron O, Meltzer E, Montague A, Crispino A, Largent A, Lucas A, Freeman L. Enrollment of Non-White Participants and Reporting of Race and Ethnicity in Phase III Trials of Multiple Sclerosis DMTs: A Systematic Review. Neurology. 2022 Mar 1;98(9):e880-e892. 
  8. National Academies of Sciences, Engineering, and Medicine. 2022. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington, DC: The National Academies Press. 
  9. Franzen S, Smith JE, van den Berg E, Rivera Mindt M, van Bruchem-Visser RL, Abner EL, Schneider LS, Prins ND, Babulal GM, Papma JM. Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria. Alzheimers Dement. 2022 Apr;18(4):810-823.
  10. Obermeyer Z, Powers B, Vogeli C, Mullainathan S. Dissecting racial bias in an algorithm used to manage the health of populations. Science. 2019 Oct 25;366(6464):447-453.

Create a List

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.

Ensure You Have the Appropriate Legal Status

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.

Gather and Organize the Medical Records in One Place

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.

Review the Medical Records to be an Informed Advocate

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

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Together, we can make a difference.

Learn more about PicnicHealth’s commitment to the Alzheimer’s community and the Alzheimer’s Association

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1

Build a support network.

If your loved one is in the early stages of Alzheimer’s, putting a support system together might not seem like priority #1. But it’s never too soon to build a network of people that you can turn to in times of need. Cultivate connections today with the people who can be there tomorrow, or whenever you might need a hand.

You may also want to connect with other Alzheimer’s caregivers through a support group, whether it meets 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 the world of Alzheimer’s.

2

Stay organized.

If your loved one is in the early stages of Alzheimer’s, putting a support system together might not seem like priority #1. But it’s never too soon to build a network of people that you can turn to in times of need. Cultivate connections today with the people who can be there tomorrow, or whenever you might need a hand.

You may also want to connect with other Alzheimer’s caregivers through a support group, whether it meets 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 the world of Alzheimer’s.

3

Plan for the future.

It isn’t always easy to look into the future with Alzheimer’s—but doing the legwork now will save you from stress later. If your loved one is in the early stages of illness, you can involve them in conversations about legal, financial, and long-term care planning decisions. Despite the difficulty of these topics, you’ll all feel empowered by facing them early, and you can move ahead with greater confidence.

4

Explore treatments and clinical trials.

It’s an exciting time for Alzheimer’s research, with new treatments in development and coming to market. Ask your loved one’s doctors about therapies they can try or clinical trials they can join. One easy way to participate in research is to sign up at PicnicHealth, which helps to advance Alzheimer’s science by sharing participants’ anonymous health data with some of the brightest minds in research.

5

Make time for self-care

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 with Alzheimer’s. And don’t forget to keep a sense of humor along the way.

Having trouble managing your loved one's medical records?

Easily manage all of your loved one's medical records and contribute to ongoing Alzheimer's research with PicnicHealth.

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25,966

patients onboarded to platform

1,427,368

medical visits processed

56,861

facilities provided medical records

255,101

healthcare providers

95+

research programs

12

published posters and manuscripts

10

partnerships withtop 30 pharma

New Research

Discover how PicnicHealth data powered medical research in 2021

Keeping Patients at the Center

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.

LC-FAOD Odyssey: A Preliminary Analysis, presented at INFORM 2021

Data from real-world medical records:

(from 13 patients with LC-FAOD)

16 yrs old

Median age at enrollment

38% Female

15 providers / patient

7.5 years of data / patient

Data from patient-reported outcome (PRO) survey

(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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Krista Meyer. PhD is the Life Sciences Research Communications Lead at PicnicHealth. She is an energetic scientific professional with a passion for bringing the best care and tools to patients in their healthcare journeys. With a knack for summarizing complex ideas into highly communicative packages, Krista loves getting elbow deep into data to share learnings and insights with broad scientific audiences.

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