Transcript Jose L. Reynal, MD VP, Trial Coordination and Site

Diversity in Clinical Trials
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Global Clinical Operations & Therapeutic Areas
Rationale, Significance, Importance of Diversity
U.S. Population Projections
U.S. Population participating in Clinical Trials
versus J&J Trials
Clinical Trials lack minority participation
Investigator/patient benefits
Responsibilities of serving as an Investigator
Q&A
 Improve speed, quality, and cost of
clinical operations
GCO
 Give all Johnson & Johnson Pharma
companies access to global clinical
development
 Provide an operational service that
can be expanded to include new
Pharma R&D companies
 Can be leveraged to other J&J
segments
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Oncology
Breast, lung, prostate, Bcell malignancies,
colorectal cancer
Cardiovascular
& Metabolism
ID/Vaccines
Heart disease, diabetes
and obesity
HIV, HCV and
influenza
Immunology
Neuroscience
Rheumatoid arthritis,
psoriasis and
pulmonary diseases
Schizophrenia, bipolar,
Alzheimer’s pain & stroke
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The United States demographic landscape has been
changing at an ever increasing pace over the last
several decades
The pharmaceutical industry has not adequately
increased the number of minority subjects to reflect the
representation within the population as a whole, nor to
reflect adequate representation for specific disease
states
The main reason for low minority representation in
clinical trials is that minority patients are more likely to be
cared for by minority physicians
The insufficient number of minority clinical
physicians/investigators has led to low minority study
subject participation into clinical trials
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If our clinical trials do not reflect proportional minority
representation in general, or disease specific proportional
representation, then the conclusions drawn regarding
efficacy and safety may be flawed.
If the subjects in Phase 2 or 3 clinical trials are not
representative of the population that is most likely to
receive the treatment, then we may see data in Phase 4
trials which may raise unexpected safety and/or efficacy
concerns.
It is highly probable that Regulatory Agencies will
mandate that clinical trials be representative of the
population most likely to be served.
Data from Clinical Trials related to diverse populations
can be leveraged to support the commercialization of
products to customers.
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Some of the most significant chronic health
conditions: diabetes & cardiovascular disease
disproportionately impact specific minority
groups (Office of Minority Health)
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County-level Estimates of Diagnosed Diabetes
for Adults aged ≥ 20 years: United States 2007
Centers for Disease Control and Prevention: National
Diabetes Surveillance System.
Available online at:
http://www.cdc.gov/diabetes/statistics/index.htm.
Retrieved 2/5/2010.
Minorities in Clinical Research
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Minorities Become Majority
2040 is Today
- % Ethnic
Population
3 States
California
New Mexico
Texas
57%
56%
54%
4 of Top 5 Cities
New York
64%
Los Angeles
67%
Chicago
67%
Philadelphia
57%
Boston
46%
*% Ethnic Population (All AA, HH
and Asian) US Census 2000, Quick
Facts
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U. S Clinical Trials
1%
3% 0%
13%
White
African Am.
83%
Hispanic
Asian, Pac Islander, N.
Hawaiian
American Indian
According to Evelyn et al (2001), the figures represent the participation of the population,
race and ethnic group, in US clinical trials during 1995-1999 (75,357 subjects)
Evelyn, B., Toigo, T., Banks, D., Pohl, K., Gray, B., Robins, B., Ernat, J. (2001). Participation of Racial/Ethnic Groups in Clinical Trials and Race Related
Labeling: A Review of New Molecular Entities Approved 1995-1999. Journal of the National Medical Association, 93 (2), 18s-24s.
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2%
3%
White
13%
Black/African Am.
Hispanic
Asian
17%
65%
Pacific Islander/N.
Hawaiian
Am. Indian/A. Native
Other/UNK/NR
Data from J&J e Clinical
14,792 subjects/US trials only
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Race/Ethnicity
2%
White
1%
12%
Black
A. Indian, Alaska
Native
Asian
28%
57%
Hispanic
Other
Data from J&J e-Clinical
2371Subjects/US Trials
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Minority physicians are interested in participating in clinical trials;
however they lack:
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awareness of clinical trials
trained clinical trial staffing
staff experience in clinical research
infrastructure
finances to conduct clinical trials
The top two criteria when considering a physician for a clinical trial are, staff
and experience; therefore, these physicians are less likely to be
approached or selected to conduct clinical research trials.
Powell, J.H., Fleming, Y. Walker-McGill, C.L., Lenior, M. (2008). The Project IMPACT Experience to Date: Increasing Minority Participation and
Awareness of Clinical Trials. JNMA v 100 (2).
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Subject
 Poor access to primary medical care
 Health care happens in ER
 Lack of preventative care
Investigator
 Perceived increased cost to recruit, retain minority
subjects
 Limited access to minority patients at academic centers
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Cultural
 Language barrier
 Patient-physician relationships
 Failure to acknowledge disease, need for treatment
 Perceived loss of control
 Role of faith
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“As a clinical trial investigator, you will play an
integral role in the development of medicines
and medical devices used to help combat
disease, treat chronic and degenerative
diseases, and improve the health of people
worldwide. You may be able to offer your
patients alternatives that could only be available
through their participation in clinical trials.”
Pharmaceutical Product Development (2011). Why be an Investigator: Retrieved February 17, 2011 from
http://www.clinicaltrials.com/investigators/advantages.htm
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• Professional development: Be on the cutting
edge of your therapeutic area of expertise, meet
other investigators, exchange ideas, plan future
collaborations, and work with investigational
medications and processes that are not yet
approved by the FDA.
• Professional recognition: Use your role as an
investigator to co-author articles for publication and
be recognized as a thought leader within the
medical community.
Pharmaceutical Product Development (2011). Why be an Investigator: Retrieved February 17, 2011 from
http://www.clinicaltrials.com/investigators/advantages.htm
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• Personal satisfaction: Offer your patients new
medical alternatives that may only be available through
participation in clinical trials.
• Compensation: Clinical trials may provide
compensation for your time and resources.
• Role in the advancement of medicine: Be a leader in
your field by potentially bringing breakthrough drugs
and medical devices – products that could impact the
health of people around the world – to market.
Pharmaceutical Product Development (2011). Why be an Investigator: Retrieved February 17, 2011 from http://www.clinicaltrials.com/investigators/advantages.htm
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Offers opportunity for patients to receive an
experimental medicine only available through a
clinical trial
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Receive specialized/focused medical care
associated with the clinical trial
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Awareness: enhance understanding of their
disease/condition
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Supervision of the conduct of a clinical investigation:
• Protecting the rights, safety and welfare of the
subjects under the investigator’s care
• Ensuring that the trial is being conducted according
to the signed investigator statement, International
Conference Harmonization (ICH) guidance for
industry, E6 Good Clinical Practice (GCP):
Consolidated Guidance are followed
U.S. Department of Health & Human Services. Food & Drug Administration. (2009). Guidance for Industry. Investigator Responsibilities-Protecting the Rights, Safety, and
Welfare of Study Subjects.
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• Understand the drug property: potential risk & side
effects
• Controlling drugs, biological products, and devices
under investigation
• Ensure that staff to whom a task is delegated is
qualified by education, training, and experience
U.S. Department of Health & Human Services. Food & Drug Administration. (2009). Guidance for Industry. Investigator Responsibilities-Protecting the Rights, Safety, and Welfare
of Study Subjects.
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Good Clinical Practice
Overview on Clinical Trials and Clinical Trial
Process
Principles of Clinical Pharmacology
Introduction to the Principles and Practice of
Clinical Research
Ethical and Regulatory Aspects of Clinical
Research
Dangerous Goods Training
Safety Reporting (i.e SAE/AE, definitions)
*On-line courses are available through NIH, CITI, and commercially available Investigator training groups
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If interested in being considered as an
investigator for upcoming J&J GCO clinical trials,
complete the short questionnaire
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