A Division of P&E Associates Limited, Inc.
14902 Preston Road, #404-744, Dallas, TX 75254   Phone: 972-517-1254   FAX: 775-252-7109
Programs & Strategies
Racial Disparities in Clinical Trials: Statement of Need
Patient Outreach & Recruitment Development (P.O.R.D.)
Clinical Trials Disease Groups
Sample Outreach for Numbers
Minority Leader Survey Results about Clinical Trials

National Baptist Congress Survey

Patient Recruitment Outreach
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Patient Recruitment Outreach


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 nine 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.

I. “PORD” Patient Outreach and Research 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.

II. Site INVESTIGATOR Lead Generation

We work to help you identify leads to Minority or Independent Medical Investigators in key cities for clinical trial recruitment. The number of sites/investigators is agreed upon in advance. Our goal is to locate qualifying African American and/or Hispanic Medical Investigators, in order to help develop equal distribution of minority clinical participants, similar to the general population of that city or state. Those cities with 10% or more African American are priority (2).

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.

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

Our objective will be to secure 1-3 investigators per city. Cities may change within a State, however, we will attempt to stay within the states targeted.

III. Patient Recruitment Outreach

Goal is to generate 12 - 20 Sites Contracted in Targeted cities for Your company’s Clinical Trials Patient Recruitment for Clinical Trials. Outreach to be developed for 8-12 cities.

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 this Clinical Trials project, P&E Associates will develop Patient Recruitment Outreach for cities to begin in June/July, 2006 through November, 2006. Second level of Phase II to run March-October, 2006.Third level of Phase III to run May-November, 2007.

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.

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.

FOR CANCER PROGRAMS: 50 Hoops National Cancer
Awareness Basketball Tournaments.

13. Ethnic Expos and Conventions
It is difficult to determine at this time which program(s) will be assigned to which city, until the first leg of Sites are approved, and we have conference with approved / contracted Sites.

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.

Each disease has it’s own program and components. We can do outreach for more than one disease at a time. However, we cannot do outreach for two or more diseases (or clinical trials) within the same program.

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 Recruitment outreach ONLY
• Targeted outreach strategy about disease and implementation of recruitment support
• Community leader outreach to recruit within formed partnerships for disease.
• Community and Media Outreach programs to recruit under served.

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.

Consultant fees are generic and based upon previous programs and Fair Market Value for services.

We can telephone conference to discuss your goals and diversity outreach collaboration.

Patricia Sanders, President NPFR
Senior Consultant, P&E Associates