A Division of P&E Associates Limited, Inc.
14902 Preston Road, #404-744, Dallas, TX 75254   Phone: 972-517-1254   FAX: 775-252-7109
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Racial Disparities in Clinical Trials: Statement of Need
Patient Outreach & Recruitment Development (P.O.R.D.)
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Patient Outreach and Recruitment Development

Overview

Thanks for the opportunity to submit this information about our minority patient recruitment outreach for use in clinical trial research. We look forward to speaking with you soon about collaboration opportunities.

P&E Associates / NPFR can greatly impact clinical trials recruitment by outreaching to recruit in minority communities. Our unique expertise lies in our ten years of partnerships and collaborations within the African American health communities. We use this knowledge to help you develop and implement a recruitment outreach strategy. This can include developing strategy, Site investigator Lead Generation or Patient Recruitment Outreach for ethnically diverse audiences. We develop client agreements around our special capabilities and your recruitment goals.

National Outreach:

Every city is different. Each city gets a different combination of outreach programs based upon the level of outreach, and city personality. It's recommended that since we can’t do all programs in any one city, that we utilize varying recruitment expertise in each city. For example, we might recruit 6 patients in one city and 100 in another. That’s why we anticipate a 18 - 24-month outreach program in order to cover as many cities/states as possible.

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Outreach Program Summary

Three Clinical Trials Outreach Programs:

OUTREACH FOR NUMBERS P.O.R.D.:

We take you where large numbers of minorities gather for conventions and conferences.  We outreach for partnership for disease education and clinical trials recruitment

OUTREACH FOR SITES

…LOOKING FOR SITE INVESTIGATORS? We network you in our target cities and surrounding areas to give you leads resources and resumes of potential Site Investigators.

…ALREADY HAVE SITE INVESTIGATORS? And need some " Pumpin' up?" We work with existing site investigators (see #3) for community and media outreach programs.  Sites targeting  African Americans and ethnic minorities are our focus, It may be setting and scheduling up a newspaper feature story (which we've generated), radio talk show with African American celebrity or survivor about disease education for the trials, creating an opportunity for a S.I. to speak before a church or participate in a fair in order to educate and recruit for trials. We find opportunities for Site to recruit with community over a 6-12 month period of time.

OUTREACH FOR SITE PROMOTION

If you have 1 - 20 cites with multiple sites and up to 3-12 key sites, you may want to ramp up the enrollment of African Americans or under served (possibly those without insurance or prescription plans) to participate in your clinical trials.  We are attuned to this market which is an untapped resource. And, with the proper education and understanding, for which we work with you to provide events and programs, can yield surprising results in many trials related to critical diseases of that culture.  We both develop events for outreach and find local event and media opportunities for Sites to develop ongoing partnerships for recruitment in key cities. ( See OUTREACH FOR SITES #b)

MARKETS:  Primary: African American; Secondary: General, Hispanic, Native American

Each disease has it’s own program and components. For companies with multiple trials, we do each trial separately.  We can do outreach for more than one disease at a time. However, we cannot do outreach for two or more disease products (or clinical trials) within the same program structure.

Program Dependence: Most Ethnic diverse programs depend upon communications advantages and disadvantages. This important information is determined city by city, and based upon (a) site support, (b) ongoing site initiatives related to disease and (c) local health networks available and in place in that city.

NOT ALL CITIES WILL HAVE THE SAME PROGRAMS. We develop a calendar of events to partner or create for that city along with, conventions, Expos and national ethnic networking opportunities in order FOR YOU TO SEE WHAT WE SHOULD BE DOING IN EACH CITY.

Our services may include:

 • Patient Outreach Recruitment ONLY

 • Targeted outreach strategy that includes disease education/awareness and implementation of recruitment opportunities

 • Community leader outreach to recruit within formed partnerships for disease.

 • Community and Media Outreach programs to recruit under served.

 •  Disease-related physician events and meetings. 

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“PORD”

I. Patient Outreach and Recruitment Development

PORD is a term we coined that means Patient Outreach and Research Development (PORD) Consultants. Our goal is to help companies work form strategies for community recruitment outreach. We help “include” diversity in your recruitment by utilizing our national partnership networks to help you come up with the best plan for your disease outreach objectives.

Our ongoing program surveys show that 63% of intelligent, well-informed African Americans said they think more clinical trials should target them and 32% said they would participate in clinical trials if asked (1). This lack of awareness by leaders is seriously off-balanced in relationship to masses of African Americans taking both OTC and prescription drugs which have passed in trials. It’s more alarming to find that most would participate if they know about them. If Black leaders are not aware, then the under served, who look to them for direction on important community issues, are even further behind-- an expansive data potential.

NPFR has many networks. Through experience we’re able to gauge “politically correct” positions within segments of the African American medical and political communities. In each community there may be from 3 to 12 key people and/or organizations that we can partner with to educate their constituencies and set up recruitment. We design your community outreach, specifically targeted to a clinical trial, and develop programs around the disease.

It is erroneous to think that a single strategy will reach all African Americans to make them available for recruitment into clinical trials. However, we feel our collaboration has added value in our knowledge of this market. Our approach reaches both the under served and most importantly the community leaders who may head large constituencies.

As part of PORD we work to implement, involve and include the ethnic communities and influential minority group leaders in this plan for the upcoming clinical trials. In order to outreach to ethnic minorities, targeted education is essential and can increase clinical trial recruitment through planned outreach designed for each community.

It is important to utilize specific strategies to capture attention and commitment of ethnically diverse audiences.

We collaborate initially during a six-month period (i.e. January through May 2006), and by the summer of 2006, can be ready to kick off outreach in a number of cities and for several clinically researched diseases. Our programs are also applicable to different ethnic races as well as different diseases.

It is important to understand that sometimes we need to think outside the box to solve some of our problems. We believe that with our excellent reputation and nation-wide networks, we can help you achieve your goal and improve the number of minorities in clinical trials for diseases that affect them most. 

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II. Site INVESTIGATOR Support

We work to help you identify outreach opportunities to Minorities  in key cities for clinical trial recruitment.  Sites/investigators are contacted  in advance to determine the best support strategy. Our goal is to locate qualifying African American and/or Hispanic patient prospects, in order to help develop pool of minority clinical participants, similar to the general population of that city or state.

P&E Associates will screen key cities for investigators or sites. To eliminate duplication, we will request list of names and cities (only) of sites already within your company’s network of Investigators for this disease. 

Recommended Cities with highest populations of African Americans (based upon 2000 U.S. Census) and/or bordering states with high population of Hispanics. Identified States having high percentage of both African American and Hispanic Populations in areas. Those cities with 10% or more African American are priority (2).

 
P&E Associates’ TARGETED Cities within STATES
Percentages are for STATES with over 10% African American population.


1. Chicago, IL- 15.1%
2. Atlanta, GA- 28.7%
3. Detroit, MI - 11.2%
4. Washington, D.C.- 60%
5. Miami, FL- 14.6%
6. St. Louis, MO - 11.2%
7. Raleigh/Durham, NC- 21.6%
8. Memphis, TN - 16.4%
9. Jackson, MS - 36.3%
10. Los Angles, CA/ San Diego **
11. Houston, TX **
12. N. Charleston, S.C. - 29.5%
13. Birmingham, AL - 26%
14. Cleveland, OH - 11.5%
15. Philadelphia, PA - 10%
Other States with significant African American population (specific cities undetermined)
16. Maryland - 27.9%
17. Delaware - 19.2%
18. New York - 15.9% (also high Hispanic Population)
19. New Jersey - 13.6%


** Indicates not states with high African Americans, but bordering state for Hispanic Population

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III. Patient Recruitment Outreach

Our Goal is to generate 12 - 20 Sites Contracted in Targeted cities for Your company’s Clinical Trials P Recruitment. Typical outreach targets 8-12 cities/sites.

Patient Recruitment Outreach may or may not encompass all cities prioritized. This will be determined by programs already in place. However, we can begin talks to determine where you are going and how we might assist.

For 18-month Clinical Trials projects, programs overlap: Phase I, Diversity Awareness Outreach (with surveys)  for key cities begins  June, through November. Phase II or Site Investigator community and media outreach support  runs March-October . Phase III , Physician and patient recruitment outreach runs May-November of following year.

Utilizing all of our Affiliate resources generated through Targeted Site/ Investigator Lead generation, P&E Associates will design city-by city outreach to support patient recruitment based upon the “personality” of each city. This includes events, community partnerships, media outreach, convention inclusions, etc.

  

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Community and Media Outreach

1. Venues: Neighborhood outreach and focus groups for paid participants.

2. Neighborhood Programs

3. City Transportation:

4. Networks:

5. Ethnic pre-promotion

6. Educational Exhibits

7. Team of Churches:

8. Public Service:

9. Celebrity Promotion:

10. Celebrity Outreach Projects

11. Media Outreach Program:

12. Direct Mail: Paid Labor Distribution.

13. Ethnic Expos and Conventions

FOR CANCER PROGRAMS we partner with :

50 Hoops National Cancer Awareness Basketball Tournaments.

We have used such tools as focus groups, media features, man on the street interviews, dinner lecture series, academic-based seminars, celebrity spokesperson promotion and others etc.

We can telephone conference to discuss your goals and the diversity outreach opportunities you may have to recruit or influence attitudes about your products and services.

 

Patricia Sanders

Senior Consultant, P&E Associates

 972-517-1254 (direct) peasoc@hotmail.com

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