Diversity in Clinical Trials. Global Clinical Operations & Therapeutic Areas Rationale, Significance, Importance of Diversity U.S. Population Projections.

Jose L. Reynal, MDVP, Trial Coordination and Site Management – Americas Region

Global Clinical Operations – J&J PRD

Diversity in Clinical Trials

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

Agenda

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Global Clinical OperationCenter of Excellence

Improve speed, quality, and cost of clinical operations

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

GCO

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J&J PRD Therapeutic Area Focus

Oncology

Breast, lung, prostate, B-cell malignancies,

colorectal cancer

Cardiovascular& Metabolism

Heart disease, diabetesand obesity

ID/Vaccines

HIV, HCV and influenza

Immunology

Rheumatoid arthritis, psoriasis

and pulmonary diseases

Neuroscience

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

Rationale for Diversity

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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.

Significance of Diversity

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Some of the most significant chronic health conditions: diabetes & cardiovascular disease disproportionately impact specific minority groups (Office of Minority Health)

Importance of Diversity

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.

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Minorities in Clinical Research

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2040 is Today - % Ethnic

Population

3 StatesCalifornia 57%New Mexico 56%Texas 54%

4 of Top 5 CitiesNew York 64%Los Angeles 67%Chicago 67%Philadelphia 57%Boston 46%

*% Ethnic Population (All AA, HH and Asian) US Census 2000, Quick Facts

Minorities Become Majority

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Participants in U.S. Clinical Trials

83%

13%3% 1%

U. S Clinical Trials

WhiteAfrican Am.HispanicAsian, Pac Islander, N. HawaiianAmerican 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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Clinical Trials: GCO 2010 RAVE Database

65%

17%

13%

2% 3%

WhiteBlack/African Am.HispanicAsianPacific Islander/N. Hawai-ianAm. Indian/A. NativeOther/UNK/NR

Data from J&J e Clinical14,792 subjects/US trials only

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Clinical Trials: GCO 2010 INFORM Database

57%28%

1% 12%

2%Race/Ethnicity

White

Black

A. Indian, Alaska Native

Asian

Hispanic

OtherData from J&J e-Clinical2371Subjects/US Trials

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Minority physicians are interested in participating in clinical trials; however they lack:

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).

Lack of Minority investigators in Clinical Trials

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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

Lack of Minority Participation

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Cultural Language barrier Patient-physician relationships Failure to acknowledge disease, need for treatment Perceived loss of control Role of faith

Lack of Minority Participation

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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

Investigator Benefits

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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

Investigator Benefits

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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

Investigator Benefits

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Offers opportunity for patients to receive an experimental medicine only available through a clinical trial

Receive specialized/focused medical care associated with the clinical trial

Awareness: enhance understanding of their disease/condition

Patient Benefits

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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.

Investigator Responsibilities

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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.

Investigator Responsibilities (cont’d)

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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

Investigator Training

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If interested in being considered as an investigator for upcoming J&J GCO clinical trials, complete the short questionnaire

Are you interested?

Q&A