Participated in clinical research before? Join our VIP program!
between science
and special populations.
Welcome to a new day in clinical research.
Clinical Ambassador is unique in the community, and in the marketplace.
We connect science and special populations to advance medical discovery and reduce disparities. And not a moment too soon. Lives are at stake.
Change (in perception, policy and practices) is critical for the survival of both citizens of color and the integrity of medical research/pharmaceutical industries, and the products they bring to market. Both have a lot at stake.
History bears the scars of all that has gone wrong with clinical research in the past. But there will be neither health equality, healthy outcomes nor scientific integrity without minority inclusion in clinical research. We each have significant roles to play. Now is the time to act on our collective obligations to know more.
Today, openness, informed consent, regulations and monitoring in clinical research are required, helping ensure patient safety and industry accountability. Underrepresentation by minorities perpetuates disparities and keeps life-saving therapies on the shelf. But access is equal parts "right" and "responsibility."
Now is the time to live up to our vast, collective potential. In so many ways, discovery holds more promise than ever. With respect, transparency and a hospitable environment, minority inclusion will become reality.
"Be the change you wish to see in the world." -Ghandi
Copyright Clinical Ambassador 2012. All rights protected, monitored and reserved.
Heads up! Before tackling our manifesto (list of core beliefs), be warned that the list below is long!
But to arrive at any meaningful changes, we have to shine a light on the roots of the problem.
Like anything of value, efforts will require time, faith, and determination, and 21 roman numerals!
Grab some coffee if you like, read on, then weigh in on our blog.
The Clinical Ambassador Manifesto
I. Clinical trials are the basis of all critical scientific information concerning new prevention, diagnosis, screening and treatment options put into use for conditions and diseases affecting all human beings.
II. Trust is a big deal. The ability to trust and apply the results of clinical trials, as well as translate them into practice and prescriptions, is related to the human volunteers who take part in those clinical studies.
III. Making significant progress with regard to reducing health disparities is seriously slowed by minorities who choose not to participate, either as volunteers or as clinical investigators in clinical research.
IV. Shifts in the racial and ethnic makeup of the U.S. require researchers to better understand the role of racial and cultural differences, how they impact study design, analysis and interpretation, and how best to engage diverse populations in clinical research.
V. Lack of minority inclusion in clinical research limits the accuracy of scientific results and leads to drug approvals that should be denied, the licensing and use of dangerous medical products, and also means that prescriptions thought generally safe for all may be recalled due to bad reactions in minority patients simply because they weren't included in the study sample.
VI. The potential of harm to underrepresented populations may not be revealed until after a drug is on the market. Equally unfortunate, new formulas thought to be useless in the general population may be of real benefit to minorities- if we know. More clinical research is required to better understand these differences, and as soon as possible.
VII. Historical medical abuses, long-term discrimination and unconscious bias on the part of researchers have created justifiable distrust among certain people toward clinical research. Earning trust back will be based on respect, research literacy, transparency, and a vested interest in better outcomes.
VIII. With low participation rates of minorities/women being a serious challenge to the integrity of clinical research, the lack of cultural confidence, competence and responsiveness on the part of industry will remain a real barrier to progress.
IX. Training researchers to be more cultural competent is now more crucial than ever, and will only be achieved by go-betweens--liaisons who can relate well with all stakeholders in order to put more aggressive inclusion measures in place.
X. The casual response of clinical researchers to the federal mandate for inclusion is problematic, and reflects lack of enforcement by law. We must put 'teeth' in current regulations to demand consistent language, tighter communication between governing bodies, and federal oversight with real penalties for lack of compliance where none currently exist.
XI. Not surprisingly, research already shows that the stress of living in a racist society has caused Black Americans in particular to experience stress-related conditions and behaviors that lead to chronic disease in higher numbers than Whites. We must vigorously demand more research that supports policy changes that impact the social determinants of health.
XII. From a purely economic and industry ROI perspective, weak patient recruitment is the number one reason clinical trials fail or experience costly delays. Patient recruitment in its current form is not working as a business model. Transforming the patient recruitment landscape, therefore, promises significant positive change industry-wide.
XIII. As the policing agents to patient protection, Institutional Review Boards (IRBs) lack consistent policing themselves. IRBs must be held to higher, more consistent standards that truly put patients--all patients-- first. IRBs must first understand, respect and acknowledge the need for minority inclusion in clinical research before they can enforce it.
XIV. A nationwide patient experience group is needed to collect and communicate feedback from past volunteers-- to capture their personal experiences, and to provide authentic perspective for community and insights for industry-- and to thank them for being heroes.
XV. Good Clinical Practice (GCP) demands a dedicated serious adverse event (SAE) registry that practitioners must be trained to utilize so that everyone is made aware when research volunteers have a bad reaction. And to improve the quality of care for all our citizens, this registry must also reflect the documented experiences of special populations in trials.
XVI. Good Recruitment Practice (GRP) suggests that patient recruitment is actually more art than science. Currently, far too much industry talk about improving patient recruitment fails to emphasize minority inclusion, fails to engage the art of communication, and fails to demand study design that tells us more than we already know.
XVII. Not only are innovative and targeted socio-behavioral strategies critical, but the community will be instrumental in designing what's best for them- from the inside out. Vested cultural competence will create the new centerpiece for trust.
XVIII. Too few clinical investigators are professionals of color. If the industry is sincere about wanting minority patients to participate, we will also need a friendlier professional environment in which to train, mentor, fund and support minority investigators in these leadership roles.
XIX. Clinical trials being conducted outside of the United States also threaten the appropriateness of therapeutic products approved for American distribution and us. Enhanced patient recruitment stateside- doing a better job of it here- will prevent the need by industry to use foreign bodies to draw conclusions about therapies that will work on us.
XX. As we pursue broader access to the promise of medical discovery, minorities will recognize the important role they play, and the danger of remaining spectators to progress. Communicating these facts is not a one-size-fits-all proposition. Special populations will gain empowerment when they have the facts delivered in culturally relevant ways.
XXI. For us, the best reward for being architects of Good Recruitment Practice (GRP) will be in evidence that minorities participate in clinical research at higher rates and are afforded appropriate treatment options because of what we do.
****
Mothers and fathers. Sisters and brothers. Aunts and uncles...
Too many gone too soon from often preventable, treatable and curable diseases. This crusade is a personal one. Family-past, present and future-is our motivation behind creating this ground-breaking, game-changing company. More than a company, this is a movement.
Unfortunately, we all know of someone (either in the limelight or simply center-stage in our own lives) who has experienced illness or disease such as cancer, stroke, diabetes or heart disease at an early age. Poor health, poor access to care, and poor outcomes plague our nation. But early-onset illness, late-stage diagnosis and premature death occurs at alarming rates in minority communities, creating the phenomenon known as health disparities.
Health disparities is simply--tragically--the disproportionate disease burden that minorities suffer as compared to Caucasians. Think about the people close to you, or even the celebrities you know of who are gone too soon: Heavy D , Luther Vandross , Israel Kamakawiwoole , Bernie Mac , Naomi Sims and countless others. Celebrity status underscores another important point: Even when income or socio-economic status are taken into account, minorities still suffer higher rates of many preventable, treatable and curable diseases. The time is now to participate in the solutions that will save our own lives.
The dark history of what is now called "medical apartheid"-- the widespread unethical scientific discovery (in abuses such as the Tuskegee Syphilis Experiment)-- created an environment hostile to minority inclusion in clinical trials. This was ultimately self-defeating.
The fallout has been twofold: minority underrepresentation in clinical research due to widespread distrust of the medical community along with overrepresentation of minorities in most disease categories due to lack of scientific progress. The industry now suffers from recruitment obstacles and shortfalls, and questions about negligent science and their inability to comply with recent mandates. The most urgent consequence, though, is persistent--and worsening--disparities for lack of minority inclusion in clinical trials.
Making headway to eliminate disparities demands universal participation, an "all hands on deck" approach. No longer can we adopt a "you first" attitude or allow ungrounded fear to paralyze us. One critical ingredient to finding answers and creating health equity is minority participation in clinical research. Racially and ethnically diverse studies offer scientific balance and insights not available any other way.
Minorities are woefully underrepresented even in studies of diseases (such as cancer, stroke, diabetes and heart disease) that disproportionately affect us, even despite strict patient protections currently in place. Even though we show higher incidence of many common diseases, we are largely missing from these studies. Since the federal mandate that went into effect in 1993 regarding the inclusion of minorities in all federally-funded research, the U.S. government monitors and publicizes all trials for more balanced representation and to reflect better medical ethics. Better safeguards from discrimination now exist.
But under-representation also compromises sound science ; the absence of special populations (minorities) not only undermines healthy outcomes but poses a threat to the integrity of clinical results. Without the inclusion of minorities (and women too) in clinical trials, we only have reliable evidence about the effects of medical interventions on white men. The vast majority of the products being prescribed and sold have been tested only on them. Are you comfortable with that? We aren't.
The clinical trial industry needs an agent with extraordinary diplomacy, vision, creativity, skills, charisma and links to the community. Not to mention uncommon conviction. Enter Clinical Ambassador.
We push the limits:
* rethinking awareness through the filter of culture & community
* facilitating dialogue
* expecting and monitoring transparency from the industry
* redesigning messages with relevant creative and placement
* retooling patient navigation & support
* representing minority patient interest at every step of the process
A critical element to recruiting minority patients for participation in clinical trials is establishing relationships. Clinical Ambassador supports the art and science of relationship-building that encourages underpresented populations to " get into the game ," insisting that nobody has a more vested interest in the process or outcomes than we do.
In essence, Clinical Ambassador is a creative communications agency with a focus on the critical intersection between cutting-edge research and underserved populations. We have carved out this niche between community and science to channel our passion for making a difference.
Besides trust and transparency, we capitalize on ingenuity and extraordinary people skills and mine for that which makes study participation 'cool.' Brutal honesty is key to bridge-building and to understanding disparities. Alongside EDICT (Eliminating Disparities in Clinical Trials), we're actively engaging populations currently underrepresented. And we know that nothing is cooler than that.
Clinical Ambassador occupies the empty space between community and scientists, between engagement and effective enrollment in clinical research, and between being paralyzed by fear and making real progress. Minority inclusion means facilitating honest dialogue, demanding transparency, creating culturally competent solutions, and managing everybody's expectations. This is what we do. Because the future is malleable. And we are change agents.
Our mission to improve minority inclusion in clinical trials is a lofty goal. It demands better understanding, trust and engagement. We acknowledge the dire need, the historical abuses and the daunting obstacles ahead. But we're gluttons for change and determined to make a difference on both sides of this equation.
Minority and scientific communities represent two separate cultures, with distinct beliefs, backgrounds, and styles of communicating. 'Cultural brokering' is defined as the act of bridging, linking, or mediating between groups or persons of different cultural backgrounds for the purpose of reducing conflict or producing change. Cultural brokers are go-betweens and those who advocate on behalf of another individual or group (Jezewski & Sotnik, 2001). Now more than ever, cultural brokers are needed in medicine to serve as system navigators, trust-builders, and empowerment advocates. That's where we come in.
We are determined to impact both sides of the disparities equation. On behalf of the community, we can improve research literacy and empowerment through well-conceived and community-tested information. To address industry challenges, we can lay the foundation for recruitment and facilitate compliance with the federal mandate for inclusion. We're a tangible solution to closing critical gaps and promoting empowerment, research literacy, and engagement in clinical research.
Some of our activities include hosting events, refereeing robust dialogues, developing ingenius marketing creative, and innovative support services to indulge all stakeholders: We're harnessing our expertise in health promotion to improve research literacy, bridge disparities, and shape a healthier future for all of us.
Resolving disparities in health and in clinical trials begins with heightening public awareness about research and the role of minorities in it. Accountabililty is a community affair. With our partners in the faith community, social service, and local organizations and businesses, each has a role to play. Together, we can relay the whole story—in the appropriate manner and in living color—in ways that cut to the chase, dispel untruths and eliminate confusion. Clinical Ambassador generates 'real' dialogue, enhances research literacy, engages motivation. We set the stage for greater trust and ser the table for broader cultural representation. For federally-funded research, our support of and demand for transparency helps ensure compliance with the federal mandate for inclusion. We also help fulfill the potential of community based participatory research (CBPR) in social and behavioral sciences in local initiatives. Survey development and implementation, focus groups, photovoice (also turned into exhibits) as well as workshops are ideal project elements to outsource to Clinical Ambassador. Our insider perspective and creative expertise gets to the heart of the matter to save precious time, resources, and lives!
It's not just a matter of black and white.
Differences in priorities, experiences, and resources make a difference, too.
Clinical Ambassador helps to voice the concerns and questions of underserved populations, and to provide authentic perspective. We also improve community access to treatment choices, provide practical information about research and the truth about becoming a participant, and explain what to expect as a study participant in a clinical trial. We provide reliable support at all stages of involvement: before, during, and after study participation. We conduct research literacy clinics and workshops; we develop community canvassing materials and surveys; and host health- and faith-based community events. Community suport activities also include related grant-seeking collaboration with non-profit organizations and churches for the benefit of their constituents and the broader community. We also conduct research literacy clinics (workshops); develop community canvassing materials and surveys; and host health-focused and faith-based community events.
Clinical investigators, drug sponsors and study staff often speak a separate language and find it challenging to communicate with a variety of patient populations. We help translate important information to improve transparency. We strengthen capacity, diversity, and reach for the sake of science. Clinical Ambassador conducts strategic outreach services, culturally competent marketing creative, focus group facilitation, and primary market research (surveys). Site support services include our proprietary study assessment tool; cultural competency trainings for sites and IRBs; as well as study orientation, patient navigation and retention services. Clinical Ambassador is available to clarify, calm nerves and avert misunderstandings. Our face time and hand-holding ensures that no participant feels confused, neglected, disrespected or taken for granted. Ever again.
It has to make sense for everyone. Clinical Ambassador specializes in cultural competence, building bridges of trust, access, and support between science and community. We're transforming the research landscape to make it easier for minoriites and other special populations to take part in medical progress. We're closing gaps and becoming architects of healthier outcomes. Our services-available nationwide-include:
(and VIPs-those who already have!)
Engage. Discuss. Inform.
Share. Collaborate. Include.
Lift your voice, up the ante, and crack the code.
Contact us here. Join the discovery revolution!
If you've ever participated in clinical research before, you can join our VIP
( very insightful participant ) program to share your story with the world.
The good, the bad and the ugly-
we want to hear about your experiences!
Our leadership team has represented the clinical research, public health, and drug development industries. We're scientists, communicators, creatives, sales and marketing experts, and members of the community ourselves. We're dedicated to better outcomes in clinical research and to being diplomatic liaisons and navigational guides for the good of science and society. Our individual and collective experiences reflect our core values: accountability, inclusion, cultural competence.
Clinical Ambassador keeps our ears to the ground by engaging community on all levels. Strength through diversity is our mission, and our street team reflects our commitment to community relationships. We share the common agenda of making a difference, understanding that progress is not a spectator sport. Across the country, we are executives, students, rappers, retirees, pastors, bus drivers, and politicians. Your experiences bring invaluable perspective and relevance to inclusion in clinical research. Please click hereto join our team.
Our industry clients include major drug sponsors, foundations, universities, clinical investigators, institutional review boards (IRBs), and patient recruitment specialists to name a few. Our clients represent universities, private research facilities, contract research organizations (CROs), hospitals, as well as the National Institutes of Health (NIH) and the Food & Drug Administration (FDA). Our clients share our vested interest in scientific integrity and the elimination of disparities in research. To engage us, or to discuss your specific needs, please click here.
Please complete this form for general questions and more information about getting involved in the fascinating world of discovery!
And for information specific to the services we provide to academic and industry clinical research professionals, click this button below to be taken to a separate portal.
Clinical Ambassador helps the biopharmaceutical industry bring more innovation to market via enhanced access to more diverse patient populations.
To introduce yourself or your study to the community, to sponsor an event, or to request a brochure, please fill out the form on this page, or email us at info_clinicalambassador.com.
Follow our blog _ http://clinicalambassador.wordpress.com/
