![Page 1: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/1.jpg)
Research Overview
Eunjoo Pacifici, PharmD, PhD
![Page 2: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/2.jpg)
Areas of Focus
• Safety • Efficacy • Quality
![Page 3: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/3.jpg)
NCATS
![Page 4: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/4.jpg)
USC’s NIH Activities through SC-CTSI
o Regulatory consulting
o Regulatory education
o Regulatory research
![Page 5: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/5.jpg)
Regulatory Consulting
– Translational Phase 1 stem cell project
– Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits • 2 close-out visits and close-out report
GCP consulting with 4 research groups • Adipose tissue • Gene therapy • Stem cell • Microbiome
43% 57%
Research Groups & Business Entities
USCAffiliated
Additional 35 small consultations: IRB, Oncore, CLIA, monitoring plans, other
![Page 6: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/6.jpg)
9:00 am Introduction Eunjoo Pacifici, PharmD, PhD | USC 9:30 am Regulatory Considerations Nancy Pire-Smerkanich, DRSc | USC 10:45 am Gene Therapy Trials and Tribulations Paula Kaplan-Lefko, PhD | UCLA 1:00 pm Clinical Trials for Stem Cell Therapies Michael Jamieson, DRSc | USC 1:45 pm Immunotherapy Trials Steven J. Swanson, PhD | Immunocellular Therapeutics Ltd. 2:45 pm CT Enabling Technologies Jonathan Cotliar, MD & Lisa DiMolfetto, PhD | Science37 3:30 pm Cutting Edge Technologies and Humanitarian Devices Gerald Loeb, MD | USC 4:15 pm Panel Discussion and Wrap-up All speakers
127 Attendees! 8 Speakers
Regulatory Education: Onsite Symposia
![Page 7: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/7.jpg)
Productivity Spinrad, A., Pire-Smerkanich, N., Pacifici, E. (2017). Applying Implementation Science to Improve the Quality of Clinical Trials in Academia. Chen, J., Spinrad, A., Pire-Smerkanich, N., Pacifici, E. (2018). Analysis of Drug Labeling for Information Specific to Geriatric Populations. Abstract submitted to Drug Information Association (DIA) 2018, Boston, MA. Chen, J., Spinrad, A., Pire-Smerkanich, N., Pacifici, E. (2018). Assessing Medication Safety: Analysis of Drug Labeling for Information Specific to Geriatric Populations. Ly, A., Spinrad, A., Pire-Smerkanich, N., Pacifici, E. Xie, A. (2018). Improving the Quality of Clinical Trials at Academic Research: Developing Training Modules Through an Implementation Science Process. Spinrad, A., Chokshi, V., Xie, A. (2018). Developing a Clinical Research Training Initiative on Practical Approaches to Monitoring and Auditing for Clinical Trials Conducted in Academic Health Care Facilities. Spinrad, A., Pire-Smerkanich, N., Pacifici, E. (2018). Applying Implementation Science to Improve the Quality of Clinical Trials in Academia.
Disseminating our findings
![Page 8: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/8.jpg)
Expanding our reach: undergraduate researchers
![Page 9: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/9.jpg)
Our Faculty Advisors
![Page 10: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/10.jpg)
Changing the Climate of Clinical Trial Diversity Expanding Medicine’s Future
Moderated by: Dr. Terry Church | Dr. Eunjoo Pacifici
Regulatory and Quality Sciences USC School of Pharmacy
Student Presenters:
Annie Ly Health and Human Sciences
Christian Reyes Pharmacology & Drug
Development
Pooja Singh Pharmacology & Drug
Development
![Page 11: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/11.jpg)
“The truth may be puzzling. It may take some work to grapple with. It may be counterintuitive. It may contradict deeply held prejudices. It may not be consonant with what we desperately want to be true. But our preferences do not determine what is true.”
- Carl Sagan, 1995
![Page 12: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/12.jpg)
Our Team
Nancy Smerkanich,
DrSC
Terry David Church,
DrSC
Eunjoo Pacifici, PharmD,
PhD
Randa Issa, PhD
Brittany Goodwell
Apurva Uniyal,
MA, MS
Annie Ly Christian Reyes
Pooja Singh
Stacy Uhm
Yu Chung, MPH, MS
![Page 13: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/13.jpg)
Climate Change
• What is climate? • If we think in terms of organizations, climate is the shared perceptions and
attitudes about the organization • It involves the shared beliefs and assumptions about expectations and values
• Sometimes the climate gets stuck in old patterns of prejudice and antiquated practices
• Climate change can and should be undertaken to move an organization, group, or culture forward
• These changes should be considered with short-term and long-term goals in mind
• Looking at current practices is often the best place to start when considering change
“Not all storms come to disrupt your life. Some come to clear your path.”
-Yiddish Proverb
![Page 14: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/14.jpg)
Clinical Trials
• Clinical Trials • Research program conducted with patients to evaluate a
new medical treatment, drug, or device • The purpose is to find new and improved methods of
treating, preventing, screening for, and diagnosing different diseases
• Clinical trials allow for the application of the latest scientific and technological advance to enter direct patient care
• There is a rigorous and constant review of ethics, safety, efficacy, and quality to reduce the chance of harm to participants
• Current climate of clinical trials • Middle-aged, suburban, caucasian males are the majority
of participants • What then does the data tell us from the research
conducted under the current climate?
![Page 15: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/15.jpg)
Women in Clinical Trials
77.84%
22.16%
58.45%
41.55%
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
PHASE I PHASE II PHASE I - FEMALE PHASE I - MALES
![Page 16: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/16.jpg)
Geriatric Drug Label Information
lack of understanding of how new drugs affect
geriatrics
knowledge gaps for clinicians and regulators
related to new drugs targeted to geriatrics
![Page 17: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/17.jpg)
Provost Research Award 2019
![Page 18: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/18.jpg)
Examination of FDA Pediatric Regulations:
Inclusion of Pediatric Participants in Clinical Trials
Annie Ly BA, Health and Human Sciences
![Page 19: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/19.jpg)
Methodology
CT Trials
Inclusive of Adult & Pediatric Populations
Inclusive of All Pediatric Sub-Populations
Exclusively Specific Pediatric Sub-Population(s)
% of Pediatric Subjects
% Newborn, % Infant, % Child, % Adolescents
Compared to Range of Sub-Population(s)
![Page 20: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/20.jpg)
Breakdown of Clinical Trial Information: Dasatinib as an Example of a Drug Approved under the BPCA
Study Title % Pediatric Subjects
% Pediatric Subjects (combined
categories*) Additional Notes
Dasatinib and Combination Chemotherapy in Treating Young Patients with Newly Diagnosed
Acute Lymphoblastic Leukemia --- 88.9%
Could not determine specific number of pediatric participants
from data presented.
Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC) 0% ---
Eligible for Study: 16 Years and Older
Trial of Dasatinib in Advanced Sarcomas 0% --- Eligible for Study: 13 Years and
Older
Therapy of Chronic Lymphocytic Leukemia with Dasatinib (BMS-354825) 0% ---
Eligible for Study: Child, Adult, Older Adult (No numerical
specification)
Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients 0% ---
Eligible for Study: Child, Adult, Older Adult (No numerical
specification)
![Page 21: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/21.jpg)
1
27
Studies with <1% Pediatric Inclusion
Total Clinical Studies
0 5 10 15 20 25 30
2016
25
69
Studies with <1% Pediatric Inclusion
Total Clinical Studies
0 10 20 30 40 50 60 70 80
2017
69
124
Studies with <1% Pediatric Inclusion
Total Clinical Studies
0 20 40 60 80 100 120 140
2018
n = 2 drugs approved
n = 11 drugs approved
n = 13 drugs approved
Overview of Results
![Page 22: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/22.jpg)
15,145 in-patient visits with ~26,503 out-patient visits who could have benefited from access to clinical trials
Children’s Hospital Los Angeles
~ 200,000 children visit ER Centers for Disease Control and Prevention (CDC)
![Page 23: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/23.jpg)
Thank you for your attention!
Any questions?
![Page 24: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/24.jpg)
Plain Language Initiative
Christian Reyes B.S. Pharmacology and
Drug Development
![Page 25: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/25.jpg)
“ “Plain language,” also known sometimes as “plain English,” is writing in a way that helps readers understand the content in a document the first time they read it. ” – U.S. Food and Drug Administration
![Page 26: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/26.jpg)
The Problem
Clinical Trial participants are not receiving results that they can understand. Some are not even receiving results at all.
The Present Only some of large industry sponsors are publishing results that are
understandable to participants. Investigator-initiated trials may not be publishing any at all.
What is a sponsor? Amgen, Pfizer, and Novartis.
Current EU regulation has pushed for the mandatory implementation of “lay summaries” by 2023.
The Process Major industry sponsors were identified based on the number of clinical
trials sponsored.
The sponsors’ websites or patient portals were then searched for availability of plain language summaries.
![Page 27: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/27.jpg)
The Products
53% 47%
Lay/Plain Language Summary Available?
Yes No
62% 38%
If No, Plans for Future Release?
Yes NoN=17 Sponsors N=8 Sponsors
Average Flesch-Kincaid Grade Level
10.2
![Page 28: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/28.jpg)
0
10000
20000
30000
40000
50000
60000
70000
80000
Numb
er of
Indiv
iduals
(Tho
usan
ds)
U.S. Educational Attainment of the Population for Both Sexes and All Races
.18 years and over
.25 years and over
Source: US Census Bureau
![Page 29: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/29.jpg)
Current Work: Templates Multi-billion-dollar companies are already
inconsistent, so what about smaller, investigator-initiated trials?
Problems could be solved through user-friendly templates.
Learn more at
![Page 30: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/30.jpg)
Diversity in Clinical Trials: Opioid Antagonists for
Opioid Overdose Reversal
Pooja Singh B.S. Pharmacology and Drug Development
![Page 31: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/31.jpg)
Background
![Page 32: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/32.jpg)
The Opioid Epidemic in the United States
● Increase in number of opioid-induced overdose deaths ○ Including prescription opioids ○ Including heroin ○ Including illicitly manufactured fentanyl
● 130+ Americans die each day from opioid overdose
● $78.5 billion annually to combat misuse of opioids
![Page 33: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/33.jpg)
What is Naloxone?
o Opioid antagonist medication o Brand names: NARCAN® &
EVZIO® o FDA-approved formulations
– Injectable – Auto-injector – Nasal spray
![Page 34: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/34.jpg)
How Does Naloxone Work?
o Rapidly blocks and partially or completely reverses the effects of opioids, especially after overdose
– Restores breathing during respiratory depression
![Page 35: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/35.jpg)
How Does Naloxone Work?
o Quick onset: 2-3 minutes o Temporary duration
– Starts wearing off after ~30 minutes – Repeat dosing often required
o Withdrawal symptoms and side effects can be experienced by the individual o Can be administered by a medical professional or a trained lay person o Only works if person has opioids in their system
![Page 36: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/36.jpg)
Results
![Page 37: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/37.jpg)
Naloxone Products and Formulations Currently on the Market
![Page 38: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/38.jpg)
Clinical Trials
![Page 39: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/39.jpg)
Clinical Trials
![Page 40: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/40.jpg)
Clinical Trials
![Page 41: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/41.jpg)
Government Actions
![Page 42: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/42.jpg)
Two Novel Developments
o Opiant Pharmaceuticals’ Nalmefene
o Insys Therapeutics’ Longer-Acting Naloxone
![Page 43: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/43.jpg)
Takeaways
![Page 44: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/44.jpg)
The opioid epidemic calls for a greater understanding of measures that can reduce the number of lives lost.
![Page 45: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/45.jpg)
Government agencies play a significant role in fighting the epidemic and influencing the development of novel opioid antagonist treatments.
![Page 46: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/46.jpg)
Development of novel opioid antagonists that can overcome Naloxone’s shortcomings is crucial in this effort.
![Page 47: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/47.jpg)
Equally important is the inclusion of diverse populations in the clinical trials of these novel opioid antagonist treatments.
![Page 48: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/48.jpg)
Inclusion of Diabetic Populations in Clinical Trials Conducted in Los Angeles County
Stacy Uhm Psychology B.A. Candidate
![Page 49: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/49.jpg)
Figure 1. Prevalence of Diagnosed Diabetes in Adults (≥18 years) by Race and Ethnicity in the U.S. (National Diabetes Statistics Report, 2013-2015)
10.7
13.7
8.2 8.2
[VALUE]*
[VALUE]*
0
5
10
15
20
25
30
35
Race or Ethnicity Pe
rcen
tage
Figure 2. Adults ((≥18 years) Ever Diagnosed with Diabetes (LACHS, 2015) *statistically unstable
Diagnosed Diabetes (all types) in US vs LA
12.1 12.7
7.4 8
15.1
02468
10121416
Perc
enta
ge
Race or Ethnicity
![Page 50: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/50.jpg)
Analysis of the 86 Clinical Trials that Reference Race
American Indian/Alaskan Native
Asian
Native Hawaiian or Other PacificIslanderBlack/ African American
![Page 51: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/51.jpg)
• Look into industry trials • Match start and end dates of clinical
trials with the time frame demographic data was obtained
Current Efforts to Improve Diversity Inclusion1
• Broaden eligibility criteria
• Target specific populations
• Improve enrollment
• Make Participation less burdensome
• FDASIA Action Plan: proposes strategies (i.e
collaborating with industry, federal agencies,
and interested stakeholders) to encourage
greater clinical trial participation and
diversity.
1“Enhancing the Diversity of Clinical Trial Population--Eligibility Criteria, Enrollment Practices, and Trial Designs guidance for Industry”
Future Research
Conclusion • Disproportionate amount of non-
Hispanic White participants • Lack of racial reporting
![Page 52: Changing the Climate of Clinical Trial Diversity Expanding ... · 3/6/2020 · 1 stem cell project – Clinical Phase Clinical trial auditors/monitors in 4 trials • 11 audits •](https://reader033.vdocuments.net/reader033/viewer/2022050514/5f9e17a485657e6ce80bf9f5/html5/thumbnails/52.jpg)
Thank You!