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The All of Us Research Program

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News, Updates and Potential for Early Career Investigators

Gregory A Talavera, MD, MPH

Principal Investigator

All of Us Research Program

San Ysidro Health

March 25, 2022

National Hispanic Medical Association

25^th Annual Conference

Crystal City, MD

Goals of My Talk

People Have Different Disease Risks

• Understand the mission, objectives, and scientific framework of the All of Us Research Program

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• Discuss the unique resource/potential currently being developed within the All of Us Research Program

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• Announce the release of the Controlled tier of data
• Announce the Genetic Health Related Return of Results

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• Describe the role and contributions of the Federally Qualified Community Health Centers to the All of Us Research Program

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About All of Us

What is the NIH All of Us Research Program?

The All of Us Research Program is a historic, longitudinal effort to gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, socioeconomics, environment, and biology, we hope that researchers will one day uncover paths toward delivering precision medicine – or individualized prevention, treatment, and care – for all of us.

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“All of Us is among the most ambitious research efforts that our nation has undertaken!”

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NIH Director Francis Collins, M.D., Ph.D.

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People Have Different Disease Risks

The All of Us Research Program is part of the broader Precision Medicine Initiative.

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Mission & Objectives

Nurture partnerships

for decades with at least a million participants who reflect the diversity of the United States

To accelerate health research and medical breakthroughs to enable individualized prevention, treatment, and care for all of us

Deliver one of the

largest, richest

biomedical datasets

that is broadly available

and secure

Catalyze an

ecosystem

of communities,

researchers, and

funders who make All of

Us an indispensable

part of health research

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The All of Us Research Program: An Innovative Research Effort

• Diversity at the scale of one million people or more

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• Focus on participants as partners

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• Longitudinal design, ability to recontact

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• Multiple data types: EHR, surveys, baseline physical measurements, biospecimens, genomics

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• National, open resource for all: broadly accessible to all researchers with open-source software & tools

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• Security and privacy safeguards for all participant data

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Two Methods of Enrollment

HEALTH CARE PROVIDER ORGANIZATIONS

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Current Protocol

Enroll, Consent and Authorize EHR

Answering�Surveys

Physical Measurements*

Provide�Biosamples*

Recruiting 18+ years old initially; plan to include children in future

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Online, interactive consent

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Includes authorization to share EHR data

Current Surveys:

• The Basics
• Overall Health
• Lifestyle
• Health Care Access & Utilization
• Personal & Family Health History
• Social Determinants of Health

Blood pressure

Heart rate

Height

Weight

BMI

Hip circumference

Waist circumference

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Blood (or saliva)

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Urine specimen

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Biosamples will be stored at the program’s biobank

*Based on diverse sampling and capacity

*Based on diverse sampling and capacity

Share data from wearable fitness devices, starting with Fitbit

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Coming soon:

Integrated apps to track mood & cardio-respiratory fitness

Wearables and Digital Apps

Additional surveys will be released on an ongoing basis

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Federally Qualified Health Centers (FQHC): Contributions to All of Us��

All of Us, the All of Us logo, and “The Future of Health Begins with You” �are service marks of the U.S. Department of Health and Human Services.

The History and Role of FQHCs in AoURP

• 7 FQHCs working with other Health Provider Organizations
• Service the underserved with less access to care
• Non Profit
• Community Board of Directors
• Accept all patients
• Urban, rural and homeless

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Waianae Coast Comprehensive Health Center

Waianae, HI

Our seven FQHCs serve nearly 600,000 patients.

FQHC Contributions

Research Hub

Data and resource access is tiered

Selected Data Snapshots

(Updated 9/21/21)

Enrollment Numbers

The following numbers are approximated to protect participants’ privacy.

Numbers are updated as of September 20, 2021.

Participants

Participants who have completed the initial steps of the program

Please update the figures before using (see notes for link). And then delete this box. Thanks!

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Participants included in All of Us data are diverse.

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Selected Data Snapshots

Race & Ethnicity

(Updated 9/21/21)

Please update the figures before using (see notes for link). And then delete this box. Thanks!

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All of Us Consortium Members (beyond community partners, as of October 2021)

The Participant Center

RMCs

All of Us California

Illinois Precision�Medicine�Consortium

All of Us

New England

Trans America

Consortium

New York City�Consortium

Participant Technology Systems Center (PTSC)

All of Us Pennsylvania

All of Us Southern Network

All of Us Southeast Enrollment Center

All of Us Wisconsin

FQHCs (Federally Qualified Health Centers)

VA Medical Centers

Communications & Engagement

Biobank

Genomics Partners

Data & Research Center (DRC)

University of Arizona�and Banner Health

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HPO Network

(Health Care Provider Organizations)

HPO Lite

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Genomic Dataset Rollout

Margaret Farrell and Tamara Moore, Communications

The Controlled Tier and Genomic Dataset is HERE!

Only available via

the Controlled Tier

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Genomics

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Assets that highlight experiences of registered researchers

Predictive analytics for glaucoma

How diverse data can power more

impactful research

Studying health care access and utilization among adult cancer survivors

Sally Baxter, MD, MSc

Assistant Professor, Shiley Eye Institute

University of California San Diego Health

Jason Karnes, PharmD, PhD, BCPS, FAHA

Director of Scientific Programs

University of Arizona/Banner Health

Jie Chen, PhD

Professor and Division Chief,

Biostatistics and Data Science

Medical College of Georgia, Augusta University

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Conclusions

• Assembling the largest, richest biomedical dataset of its kind with plans for genomic data and comprehensive clinical information

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• Successfully engaging participants as partners

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• New data types continuing to be rolled out

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• Ancillary studies of specific populations or disease states possible

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• Will facilitate research across multiple disease states and could serve as controls for disease-specific studies that lack healthy controls

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Thank You!

AllofUs.nih.gov

JoinAllofUs.org

ResearchAllofUs.org

@AllofUsResearch

#JoinAllofUs

It takes All of Us….

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Clinical Trial Projects for Latinx Physicians�

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Joseph Martel, MD

Assistant Dean of Graduate Medical Education

Chair, Department of Ophthalmology

California Northstate College of Medicine

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SoloKiko.org

The largest racial/ethnic minority group in the United States and is projected to continue increasing,

reaching 29% by 2065. In 1980, the Latinx population comprised only 5.4% of the US population. By 1990,

we comprised 9.0%, in 2000 12.5%, and by 2006 14.7%.

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Latinx Population

Hispanics will continue to become larger consumers of health care in the US

Latinx under-representation in clinical trials

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• Minorities have historically been underrepresented in clinical trials.

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•  In 2011, African Americans and Hispanics comprised 12% and 16% of the US population, respectively, but only 5% and 1% of trial participants were African Americans and Hispanics, respectively.

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So why are clinical trials so important?

 �Why is diversity in clinical trials so important?�

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• The diverse enrollment of subjects engaged in clinical trials research is, thus, critical to developing safer and more effective drugs and medical devices.

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• According to a review of 167 new molecular entities approved by the Food and Drug Administration (FDA) between 2008 and 2013, approximately 1 in 5 had differences in exposure, response across racial or ethnic. groups

Example of the Demographics of an approved Diabetic medication:

Barriers to Diversity

Latinx Physicians are uniquely position to address this problem

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• Serve Latinx community
• Culturally sensitive and competent
• Generally, speak both English and Spanish
• Have the trust of the community
• Understand their patients needs
• Frequently have family members afflicted by these illnesses

Latinx Physicians can Improve Diversity

• Make a commitment to improve diversity in your clinical trials
• Identify barriers to recruitment and enrollment- ask the patients and staff what barriers they perceive
• Develop cultural competence in yourself and your staff

a. referring physicians

b. Investigators

c. Study coordinators

• Acquire the necessary documents to conduct clinical trials with bilingual communities
• Develop a recruitment/enrollment program that will optimize diversity in your clinical trials based on your practice

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Some Pearls

• Latinx physicians are uniquely positioned to improve diversity so consider doing clinical trials

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• Often Clinical Sponsoring companies do not automatically include translation of research material to include Spanish. Once this issue is raised “in writing” they almost universally comply

• Hispanic patients without a social security are often reluctant to participate because they are afraid of being reported to the government because of the 1099 tax form. This is not a significant issue if patient stipend is under $600 and no 1099 is required

• You can do a lot of good, and it can increase significantly your practice income

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..Our Team

Drug Development

CLRI

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Edward Mena., MD FAASLD,MBA

CEO of California Liver Research Institute (CLRI)

Pasadena Liver Center (PLC)

Hispanics are now the highest group in the US at risk for liver cancer. WHY?

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In Hispanics, liver cancer is 2x as likely vs. non-Hispanic whites.

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• Nearly 50% of Hispanics live with Fatty liver disease —NAFLD— is caused by a combination of obesity, diabetes.

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• Hispanics are 2x as likely to develop type 2 diabetes vs. non-Hispanic whites. 

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Sign up to learn more at a future, free online LIVE event delivered by a Physician Expert.

Phase 1

• Purpose: Safety and Dosage
• Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects
• The drug will be tested in a small group of 15 to 30 patients healthy volunteers or people with the disease/condition participate in Phase 1
• looking at what the drug does to the body and what the body does with the drug
• Placebos (inactive treatments) are not used in phase I trials

Phase II

• Purpose: Efficacy and Side effects
• researchers administer the drug to a large group of patients with the disease or condition for which the drug is being developed
• researchers answer research questions related to
• how it works in the body
• the side effects associated with increased dosage
• early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits
• Phase 2a is focused specifically on dosing requirements
• Phase 2b trials are designed specifically to rigorously test the efficacy of the drug in terms of how successful it is in treating, preventing or diagnosing a disease

Phase III

• Purpose: Efficacy and Monitoring of Adverse Reactions
• design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population
• known as pivotal studies, involve 300 to 3,000 participants
• Often, these trials are randomized
• means that patients are put into a treatment group, called trial arms, by chance. Randomization is needed to make sure that the people in all trial arms are alike
• Phase 3a
• To get sufficient and significant data
• Phase 3b
• Allows patients to continue the treatment

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FDA Approval

• when phase III clinical trials (or sometimes phase II trials) show a new drug is more effective or safer than the current treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval
• Based on the review, the FDA decides whether to approve the treatment for use in patients with the illness the drug was tested on
• If approved:
• the new treatment often becomes a standard of care and newer drugs may be tested against it before they can be approved
• If the FDA feels that more evidence is needed to show that the new treatment's benefits outweigh its risks, it may ask for more information or even require that more studies be done.

Phase IV

• Purpose: Safety and Efficacy
• Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring
• Phase IV studies look at drugs that have already been approved by the FDA. The drugs are available for doctors to prescribe for patients
• The drug is tested in several hundreds or thousands of patients
• Phase IV studies look at safety over time

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How do you start the Infrastructure

• The goal needs to be which disease state you plan to study
• What phases of clinical trial development are you interested in studying
• You will need to start with a Research Coordinator, research assistant and budget coordinator.
• The structure of your organization
• Nonprofit 501C3
• For profit LLC
• What type of IRB (Institutional Review Board) do you plan to work with
• Central
• Local IRB at your current institutions

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How to connect to larger system Trials

• Join a Consortium
• Research networks
• Meet with MSL (Medical Science Liaison) of the company and disease state. Connect with the company doing the research
• Gilead, Novartis, BMS, Pfizer, etc.
• Talk with other physician conducting clinical trials in the same disease state.
• The questions that all pharma would like to know is how quickly can you start the clinical trial and how do you plan on enrolling patients.
• From your personal clinic? Hospital or group practice?

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How do you recruit Hispanic patients and retention

• The key is trust.
• Knowing that you have their best interest in mind
• These studies are highly regulated by the FDA
• Lose the fear of clinical trials
• Guinea pig scenario
• Fear of being at big medical centers
• Discuss safety and efficacy
• The importance of studying disease effects on our specific population
• Hepatitis C and NASH
• NASH genetic predisposition
• Education to our providers on the importance of Clinical trials and drug development
• Cost of Clinical trials
• free
• Transportation
• Site will provide transportation

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How did I get training

• I did research through most of my career
• Trial and experience and jumping into clinical trials and opening a clinical trial center
• Mentorship
• Working with physician and peers who have done clinical trials
• Networking and Consortiums
• NHMA has research network - on Hispanic research
• NHMA setting up conferences and networking capabilities among Latino physicians doing clinical trials
• Expanding young physicians in participating in clinicall trials

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Pharma

• Pharma is always willing to partner with active a successful sites
• More willing to partner with non-academic centers to speed the enrollment process by using a Central IRB
• Once successful the pharma will continue to use your site for all future and upcoming studies.
• They help with equipment, training of staff, etc.

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CLRI studies

Research Hound

• App designed to connect patient to clinical trial centers across the country

Thank you

Importance of diversity and inclusion in clinical trials and the potential it brings

Yvonne Rodriguez

Clinical trial populations are not reflective of the target population who will use the medicine

Historically, Industry sponsored ≠ NIH trials

Underrepresented populations are needed to ensure validity of results and reliable benefits to all

Oncology: Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018 JAMA Oncol. 2019;5(10):e191870. doi:10.1001/jamaoncol.2019.1870

Latest FDA Snapshot of representation

FDA Guidance driving new industry initiatives

Clinical trials, and the people who volunteer to participate in them, are essential to help develop safe and effective medical products to fight diseases and illnesses.

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The FDA guidance provides recommendations for how sponsors can increase enrolment of underrepresented populations in their trials.

https://www.fda.gov/news-events/press-announcements/fda-offers-guidance-enhance-diversity-clinical-trials-encourage-inclusivity-medical-product

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Why is this FDA Guidance important?

Information taken from National Quality Minority Forum presentation

Clinical trial designs are not relevant for patient populations

Representative data about true patient population missing from clinical guidance

Patient counseled with wrong information

Physician prescribes wrong or no test/treatment available

What is the potential?

• Clinical trials as a care option
• Providing hope and access to your patients
• Opportunity to offer patients latest cutting-edge therapies
• Contributes to expending knowledge base of medicine
• Ability to diversify your practice –
• This could be a value add for the patients in your practice.
• Earn an honorarium, average income is $66,248 as of Feb 25, 2022.
• Range falls between 60,473 and 72,658
• This can vary depending on education, certifications and additional skills, including the number of years you have in your profession.

What infrastructure do you need?

• Clinical Research Coordinator
• Able to identify potential participants in your patient charts/EMR
• Scheduling
• Conducting visits
• Data Entry
• Laboratory Technician
• Project Manager
• Budget
• Key person that will identify what you can negotiate per assessment
• Legal
• Review documents to ensure your rights are protected

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NHHF National Center for Hispanic Health Research

• Educational webinars to highlight guidance
• How to interpret code of federal regulation
• Mentorship for physicians wanting to get started in clinical research
• Best practices to run a successful trial
• Maximize use of medical records to highlight potential to sponsors
• Understanding requirements that are important to good clinical practice
• Drug storage
• Local Labs
• Medical equipment (eCG machines, centrifuge, calibrations)

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NHHF National Center for Hispanic Health Research

• Goal of building relationship with Collaboration with Parexel Academy and Parexel (Global Clinical Research Organization) to support community sites through educational programming and access to clinical studies
• Goal of building partnership with CISCRP (Center for Information & Study on Clinical Research Participation)
• Partnerships with Egality Sciences, a group of clinical research professionals, ready to help your site is set up for success.

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Take away

• We recognize there is a problem
• FDA provided guidance
• Egality Sciences, PAREXEL Academy, NHHF led by Dr. Rios, and other organizations are partnered up to actualize FDA guidance to create the solutions for your practice