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Breakout Session A

Disease Process and Disparities

AccreditationUAN 0024-0000-12-009-L04-P

Participation in this activity earns 1.75 contact hours. To receive credit, participants must complete an evaluation form at the conclusion of this session.

Presented at the Xavier of Louisiana College of Pharmacy's Fifth Health Disparities Conference | March 6-8, 2012 | New Orleans, LA

All Rights Reserved - No forms of duplication nor distribution allowed without author's consent

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Breakout A

At the completion of this activity, participants will be able to:

• Discuss research methods and approaches to address disease processes and healthaddress disease processes and health disparities; and

• Discuss strategies for translating evidence‐based clinical guidelines to their own practices.

OPENING REMARKSJanel Bailey-Wheeler, PharmD

01.01.01 – ANTIOXIDANT EFFECTS OF SEP IN LIVER TISSUE FROM DIABETIC RATS

Ugochukwu J. Agwai, BS



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Antioxidant effects of sepiapterin (SEP) in liver tissue from spontaneous diabetic (Type I) rat

Agwai Ugochukwu, Chinnatambi V, Mukhopadhyay S, Ravella K, Shackel J, Gangula PR

Meharry Medical College, Center for Women’s Health Research, Nashville, TN-37208

Background

• Aim: To investigate whether spontaneous diabetes causes a change in liver oxidative stress levels, and if so will supplementation of SEP restore levels back to ppnormal?

• Hypothesis: Levels of oxidative stress in diabetic animal liver tissue is higher compared to non-diabetic animals, as measured by antioxidative markers. Supplementation with SEP decreases levels of oxidative stress in diabetic animals compared to non-supplemented animals.

What is SEP?

• SEP is a substrate for tetrahydrobiopterin (BH4) synthesis via the salvage pathway. BH4 is an essential co-factor required for the degradation of phenylalanine, biosynthesis of neurotransmitters, and it serves as a catalyst for the production of nitric oxide (NO).

• The role of NO in the liver is still controversial, but we believe that when generated constitutively, it serves a protective function for the liver. This is primarily based on the vasodilatory effects of NO.



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Design methods

• Adult ovary-intact female Sprague Dawley rats (9 wks old) were selected in the present study.

• Diabetes was induced in overnight fasted animals by a single• Diabetes was induced in overnight fasted animals by a single intraperitoneal injection of streptozotocin (STZ, 55 mg kg−1).

• Control animals were injected with the vehicle (9 mmol citrate buffer, pH 4.0).

• Blood glucose levels were examined in overnight fasted animals, 48 h post STZ injection. Animals exhibiting blood glucose levels more than 250 mg dL−1 were considered diabetic and included in the study. Blood glucose levels in vehicle-treated overnight fasting rats ranged between 80–95 mg dL−1.

• At the end of 8th week of diabetes induction, animals were divided into three groups, i.e. control female rats (C), diabetic female rats (DB), and SEP tablets (20 mg/kg b.w/10days) supplemented diabetic female rats (DB + SEP).

• Liver tissue samples were collected from non-diabetic rats as control, SEP treated rats and spontaneous diabetic rats as experiments.

• Tissue samples were snap frozen in liquid nitrogen and stored at −80 °C until analyzed. Proteins were measured by Bio-Rad protein assay (Bio-Rad, Hercules, CA, USA) and 30 μg protein was separated by 6% SDS polyacrylamide gel electrophoresis (SDS-PAGE).

• The samples were homogenized into smaller pieces, andThe samples were homogenized into smaller pieces, and protein concentration estimation was performed using Western Blotting methods.

• We explored the levels of oxidative stress in the liver from spontaneous diabetic rats using antioxidative markers.



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Antioxidant markers used• Nuclear factor (erythroid-derived 2)-like 2 (NRF2): interacts with KEAP-1

to facilitate the expression of Glutamate-cysteine synthetase (GCS).

• Kelch-like ECH-associated protein 1 (KEAP-1)

H (HO 1) th t t l th d d ti f• Heme oxygenase (HO-1): an enzyme that catalyzes the degradation of heme, it responds to oxidative stress.

• Glutamate-cysteine synthetase catalytic and modulatory subunits (GCSc/m): the rate limiting step required for glutathione biosynthesis. Glutathione is a tripeptide that acts as an antioxidant to protect cells from free radicals.

• Dihydrofolate reductase (DHFR): an enzyme required for tetrahydrobiopterin (BH4) synthesis.

Results

1 4

2.1

2.8

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CONT DIA-II SEP



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Conclusions

• Spontaneous diabetes causes an increase of oxidative stress in the liver causing damage of liver functionsliver functions.

• According to the results, supplementation of SEP may become beneficial in reversing the damage of oxidative stress seen in diabetic patients.



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Acknowledgements

The project described was supported by NIH/NCRR – 2G12RR003032-22 Meharry RCMI program and the Meharry Women’s Health Center I would like tothe Meharry Women s Health Center.. I would like to thank them for their continued support.

02.02.06DETERMINATION OF BODY FAT

Pratibha Phadke-Gupta, PhD



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DETERMINATION OF BODY FAT: A PILOT STUDY MEASURING BODY COMPOSITION AMONG COLLEGE ATHLETES AT A HISTORICALLY BLACK COLLEGE/UNIVERSITY

Presenter :Pratibha Phadke‐Gupta, PH.D , Research Assistant P f C f All i H l h Di i i Professor , Center for Allaying Health Disparities

through Research and Education (CADRE)

Co‐Presenters; Daniel Shook, PhD.; Joshua Searcy, PhD; Greta Winbush, PhD; Karen Mathews, MD; & Kellen Winslow, JDDepartment of Health, Physical Education, and Recreation; Department of Social and Behavioral Sciences; Student Health & Counseling Services Center; & Athletics and Student Wellness

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HUMAN EXERCISE AND PERFORMANCE LABORATORY (HEPL) at Central State University

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INTRODUCTION

Obesity and Diabetes in AfricanAmericans

Objective

S ifi Ai Specific Aims

ResearchMethods

Evaluation of BodyComposition

Clinical Relevance

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Obesity and Diabetes in African Americans

Type 2 diabetes and obesity are major public healthpriorities because of their high prevalence and incidence

African Americans have the highest prevalence to obesity(29%) and diabetes (11%) among racial groups

Obesity and diabetes are strongly associated with otherdi ith hi h t lit tdiseases with high mortality rates: Hypertension Coronary artery disease Cancer

Non‐drug treatments: Diet Physical Activity

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Objective

The purpose of this investigation was threefold:

Present a profile of body composition assessment using air displacement plethysmography on a population of plethysmography on a population of college athletes at Central State University

Evaluate Body Composition

Determine body fat in College Athletes

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Specific Aims

1. To Determine Body composition

2.To Evaluate and asses specific Composition

3. To Identify risk associated with and based on body composition

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Importance Of Body Composition

With obesity on the rise and diseases associated with excess body fat becoming more involved body fat becoming more involved, the need to measure body composition has become more important than ever

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Body Composition:%Fat and %Fat Free Mass

Body composition is a measurement of a person’s fat mass and fat free (lean) mass

Testing body composition is a great way to monitor and reach realistic health and fitness goals

Weight and BMI can be less specific in relation to a person’s general health and individual goals

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Research Method

Recruited student athletes involved in any sports activities such as volley ball, basketball or any other athletic sport to participate in the study sport to participate in the study

51 college athletes male and female, (average age 21) participated in the study

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The BOD POD is an Air Displacement Plethysmograph(ADP) that uses whole‐body densitometry to determine body composition (fat vs. lean)

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BOD POD measures body mass (weight) using a very precise scale, and volume by sitting inside the y gBOD POD. Body density is calculated: Density = Mass/Volume

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The relative proportions of body fat and lean body mass are calculated. yThis 5 minute test is considered very accurate (+ or – 2%), fast, easy, and non invasive

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Body Composition:%Fat and %Fat Free Mass

Body composition is a measurement of aperson’s fat mass and fat free (lean) mass

Testing body composition is a great way toTesting body composition is a great way tomonitor and reach realistic health and fitnessgoals

General measurements such as weight and BMIcan be less specific in relation to a person’sgeneral health and individual goals

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Where is the fat?

Visceral fat is also known as organ fat or intra‐abdominal fat

Subcutaneous fat is found underneath the skin

Fat free mass is comprised of all of the fat free l t f th b d t h l i t i ti iti f elements of the body to help maintain activities of

daily living and to help prevent diseases such as osteoporosis

It is important to eat adequate calories and use resistance training to maintain more fat free mass, especially during weight loss

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BODY FAT IN WOMEN

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Study Results in Body Composition

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FEMALE DISTRIBUTIONS BY BODY FAT CATEGORIES

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7 7

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FEMALES ‐ BODY MASS VS % BODY FAT

Body Mass (lb)

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SUBJECT

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BODY COMPOSITION IN FEMALES

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Body Composition Lean Weight and Body Composition Fat Weight and Body Composition % Fat:

Female Basketball Athletes

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Basketball Athletes

body composition lean weight

body composition fat weight

body composition % fat

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BODPOD % Fat, % Fat Free Mass, Fat Mass, Fat Free Mass, Body Mass: Female Basketball Athletes

bod pod % fat

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bod pod % fat free mass

bod pod fat mass

bod pod fat free mass

bod pod body mass

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BODY FAT IN MEN

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MAINTAIN HEALTH

CONCLUSION:

Studies have shown that a combination of physical activity

d ll i t i d di t and a well maintained diet produce the best effect of a decrease in fat mass and a maintenance or increase in muscle mass

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CONCLUSIONS

Body composition, or fat vs. fat‐free (lean) mass, reflects the results of a person’s physical activity and nutritional practices.

Monitoring body weight alone can be very misleading, because a scale can’t tell the difference between a pound of fat and a pound of muscle

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CONCLUSIONS

Sedentary people sometimes gain fat and lose muscle without any noticeable change in their weight

While on an exercise/weight training program a person may not experience a significant change in weight, yet their muscle mass is most likely increasing, while they are also probably losing body fat

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OPTIMAL HEALTH AND CLINICAL RELEVANCE

Benefits of maintaining a healthy body composition

A healthy lifestyle including a well y y gmaintained diet and adequate physical activity can produce many health benefits and increase quality of life

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Some of these health benefits include a decrease in risk for and improve conditions in improve conditions in cardiovascular disease, diabetes, metabolic disease, osteoporosis and a host of other diseases

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Regular physical activity and maintenance of a healthy body composition can also improve ability p p yto perform activities of daily life, increase energy and help to maintain cognitive function and decrease stress

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QUESTIONS

THANK YOU

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01.01.04RURAL COMMUNITY-BASED CANCER CLINICAL TRIAL PROGRAM

Mary S. DeShields, MD

Rural Community Based Cancer Clinical Trial Program: A National Best Practice Model Which Addresses Disparities in Clinical

Research Participation

CLAUDIA R. BAQUET, MD, MPHM De Shields, MD; J Bromwell; S Richter

University of Maryland School of Medicine, Eastern Shore Cancer Research Network; Eastern Shore AHEC, Shore Health System

Xavier University of Louisiana Fifth Annual Health Disparities Conference

March 6‐8, 2012



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Factors Contributing to Cancer and Health Disparities

• Risk factors/exposures

• Biologic and genetic determinants

• Health care determinants (access

• Socioeconomic status

• Cultural competence and cultural determinants

L k f ti t t d

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to care, health insurance, quality, bias in care delivery)

• Co‐morbid conditions

• Treatment disparities – NOT based on clinical factors and evidence

• Lack of patient centered care

• Post‐treatment access to and compliance with care

• Low participation/retention rates in clinical trials

• Differences in pain management, palliative care

Assuring Diversity in Clinical Research Participation

• A national priority

• Minority, uninsured, poor, and rural communities have lower participation rates.

• Underserved communities experience substantial health disparities.

• Barriers across multiple levels impede participation

• Building community-academic partnerships and community trust is essential.

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Issues in Cancer Clinical Trial Participation

• 2011: – Estimated 1.4 million new cancers diagnosed– Over 500,000 deaths projected

• 3-5% of cancer patients participate in clinical trials

• Low participation by underserved communities (African American, uninsured, poor, rural)– A declining percentage of African Americans participating

• 32% of Americans would be willing to participate in trials if asked; an additional 38% would be inclined to participate if asked but had questions/reservations.*– Factors other than patient intent or willingness present barriers to

participation in clinical trials.**

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*Comis RL, et al. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. Mar 1 2003;21(5):830‐835.

**Baquet et al. 2008.



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Barriers to Research Participation

• Patient

• Health care professional

• Structural design co-morbidityStructural, design, co morbidity

• Knowledge and awareness in general public

• Insufficient community infrastructure to support clinical research and trials

• Historical factors

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Researcher Barriers

• Lack of training in:– Cultural competence – Culture and health – Disparities

• Communication skills– Literacy– Literacy– Language– Sensitivity

• Lack of culturally tailored approaches to trial accrual and retention

• Fear or distrust of academics/researchers by patients and community

• Partnership and sharing skills– Not sharing results

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Approach: Fostering Public Trust in Research and Trial Diversity

• Issues:– Lack of public trust and need for diversity in research participation

– “Research Literacy”• Community: Lack of basic information on why research is• Community: Lack of basic information on why research is

important, how it is designed and reported; concern for “helicopter research; ethical protections for research participants

• Community Primary Care Clinicians: Fear of losing control over patient care; distrust of academia and “stealing “patients; how to refer/enroll patients in studies; need for feedback from researchers

• Historical research abuses and scandals affect public trust

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• Examined relationship of socio-demographic factors on accrual of Maryland cancer patients to NCI sponsored cancer treatment trials– n=2,240 Maryland cancer patients accrued onto NCI-sponsored

treatment trials (1999-2002)

• Purpose: To determine extent to which Maryland cancer patients and patients residing in lower SES and/or rural areas were accrued to cancer t i l d t ti f ll ti t i M l d

Accrual of Maryland Cancer Patients to NCI sponsored Treatment Clinical Trials Study

trials and were representative of all cancer patients in Maryland.

• Data sources: – NCI’s Cancer Therapy and Evaluation Program (CTEP) for Maryland

cancer patients– Maryland Cancer Registry – US Census and the Department of Agriculture

64Baquet CR, Ellison, G, Mishra, S et al. Analysis of Maryland Cancer Patient Participation in NCI Supported Cancer Treatment Clinical Trials. Journal of Clinical Oncology. July 2008.

Accrual of Maryland Cancer Patients to NCI sponsored Treatment Clinical Trials

Baquet CR, Ellison, G, Mishra, S et al. Analysis of Maryland Cancer Patient Participation in NCI Supported Cancer Treatment Clinical Trials. Journal of Clinical Oncology.July 2008. 65

Maryland Clinical Trial Barrier Research“Multivariate Predictors of Recruitment and Participation in Clinical Trials”

• Were significantly more likely to be recruited:– in poor health (OR=1.83, CI=1.21-2.76), – had public health insurance coverage (OR=1.98, CI=1.57-2.51), and – had some college or higher level of education (OR=2.32, CI=1.84-2.92).

• Were significantly more likely to actually participate:e e s g ca t y o e e y to actua y pa t c pate– informed about clinical trials by their health care provider (OR=1.69,

CI=1.08-2.65), – knowledgeable about clinical trials (OR=2.09, CI=1.26-3.46), and– able to make the time commitment (OR=1.67, CI=1.06-2.63).

• Black respondents were significantly less likely to be recruited (OR=0.61, CI=0.44-0.85) and less likely to participate (OR=0.38, CI=0.21-0.68) in clinical trials.

66Baquet CR, et al. Recruitment and Participation in Clinical Trials: Socio‐Demographic, Rural/Urban, and Health Care

Access Predictors. Cancer Detection and Prevention. 2006; 30.



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Strategies for Overcoming Barriers and Increasing Participation

FORMAL PARTNERSHIPS : • Public and Ministers Model (Times Community Services)• Clinical Eastern Shore (Eastern Shore CRN)• Print Media

COMMUNITY PARTICIPATION AND EMPOWERMENT:• Faith and community based organizations: Ministerial Alliances • Local health departments and community hospitals and FQHCs• Print and broadcast media• Policy makers

TRAINING for research personnel regarding:• Community concerns• Communication • Sharing results

INFRASTRUCTURE: Cover regulatory & data expenses

COMMUNITY HEALTH PROFESSIONAL: AHECs CME/CE:• Physicians and Nurses• Urban and rural

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Maryland Community Clinical Trial Program Components

• Research: Barriers and Strategies– Random digit dial (RDD)– Qualitative research– Results used to target

educational/awareness efforts– Theory based

education/outreach

• Community engagement – Faith-based– AHECs– Print Media– CBOs– Local Health Departments– FQHCseducation/outreach

• Track accrual rates/trends– CTEP analysis

• Health care professionals– Trial referral– Continuing Education– Grand Rounds

• Training for Researchers

– Formal Partnerships

• Policy Research and Advocacy

• Community based infrastructure

• Technical Assistance for elected officials and staff

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Clinical Trials in Rural Maryland



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Why rural community based trials?

• 80% of cancer patients are treated in community clinics

• Participants should reflect the heterogeneity of the US l iUS population

• Accrual shortens the time from discovery to delivery of novel therapies

• Provide state of the art therapy

Stakeholders

• Patients/participants

• Society

• Physicians

• Local Health Systems

Shore Regional Cancer Center



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Barriers to Participation

• Less than 5% of adult participants are enrolled in clinical trials:

– Clinical trials not available

– Not presented as a treatment option

– Screen failure due to stringent eligibility requirements

– Enrollment failure due to fear/mistrust

Unique Challenges in Rural Communities

Elderly population

Cultural and geographic Barriersgeographic Barriers

Physician refusal

Patient refusal



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Key Components

• For a successful community program:– Funding Source(s)

– Physician “champion”

– Dedicated on site clinical trials research nurse

– Data manager

– Institutional Review Board; local or central

– Infrastructure

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Three Point Approach

• Physician awareness and support

• Patient awareness

• Community awareness

Outcomes

• Clinical trials for all major sites of cancer opened within the first year

• Three major cancer prevention trials NSABP P1, NSABP P2 and SELECT opened with excellent accrual

• Cumulative patient enrollment increased from three to 136 as of December 2011

• 20% African American Participants (2011)

• Successful completion of audits by CTSU, ECOG, SWOG

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Clinical Trials Accrual 1999‐2008

40

50

60

70

80

90

# Trials

0

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40

1999‐20002001‐2002

2003‐20052005‐2008

# Accrued

#Total

Funding and Support

• NCI U01 CA 144650

• Maryland Statewide Health Network

• Susan G. Komen for the Cure, Maryland

• Research Bases: Eastern Cooperative Oncology Group and ACOSOG

• Fox Chase Cancer Center Community Affiliate

• Cancer Trials Support Unit (CTSU)

National Best Practice Award

US Department of Health and Human Services

Secretary’s Committee on Science and Policy

Maryland Community Clinical Trial Program

• A Model For Increasing Availability Of Community-Based Cancer Clinical Trials In Rural Eastern Shore Maryland, September 2004

– http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1

• Awarded to Claudia Baquet, MD, MPH and

Mary De Shields, MD

81Supported by: NCI MSPN/CNP; NIH/NCMHD P60; MD CRF; Susan G. Komen For The Cure Maryland



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Bioethics Research Infrastructure/Center Grant

• Funding agency: NIMHD/NIH

• Grant number: RC2MD004761

• Goals: – foster public trust in research, – education/training on bioethics, and – increase minority, rural and underserved community

diversity in research participation including clinical trials.

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Health Professional CME/CE Programs

• Initial programs have been 2-hour live (face to face)

• Pre/Post Assessments

• CME evaluation and credits

• Web based programs currently being developed

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Community Bioethics Mini Medical School

• The Mini Med program provides the general public to receive basic i f ti bi thi

Goal: Remove mystery and stigma of research and participation

information on bioethics, clinical trials, how research participants are protected and the role of ethical research in improving health.

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Bioethics Center Programs and Research: Taking Our Expertise Nationally

• Community Bioethics Mini Medical Schools

• Physician and Nurse CME/CE

• Faculty, Trainee Summer Course and Fellowship

• African American Community Newspaper Journalist TrainingTraining

• National AHEC Organization

• Research on Informed Consent and Ethics

• Summer High School Science Teachers

• Web based HSP and HIPAA Training

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Outcomes to Date

Public education

– 2100 trained in research ethics, bioethics, clinical trials 101

– Nurses/Physicians: 160 CME/CE

– 25% rural African American cancer trial participation

– Cancer Center: 38% African American accrual

– CKD Trials: 60% African American

– 15 National Bioethics Fellows

– Two community IRB members: 6 additional being processed

– Greater willingness to participate in research studies as well as tissue donation

– Greater willingness to refer patients to trials

– Over 2000 web based trainees/certificates

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Thank You

QUESTIONS AND ANSWERSPanel Discussion

Thank you for your participation!



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