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Industry Leader The Business Of Equitable Research: The New Stakeholders By James Gillespie and Kathleen Drennan F 32 or an industry com- mitted to delivering innovative health- care, and where science outpaces antiquated trial plan- ning and processes, there is no better time than now to take stock of the current burgeoning shift in population demographics and how it will affect the business of new drug development. But could it take another few decades to bridge the disparities gap of underrepresented patient populations in clinical trials compared to disease incidence — spe- cifically Black/African Americans and Hispanic/Latinos, who will be the larg- est consumers of healthcare (2010 U.S. Census)? It took until the middle of the 1990s to acknowledge the lack of inclusion of women in clinical trials in any significant numbers, leaving a legacy of medicines extrapolated from studies done only in men. The industry missed opportunities to recognize crit- ical scientific and gender issues affect- ing optimum treatments and outcomes in women's health, and it missed the biggest opportunity of all: Women are the largest buyers and decision makers of healthcare purchases. A COMPLEX CHALLENGE AND STRONG CALL TO ACTION The FDA is rapidly pushing the current diversity agenda of reducing disparity between disease incidence and preva- lence in minority populations and the sample size represented in clinical trials. The FDA established the Office of Minority Health in 2010 to advance the Agency's regulatory oversight in LifeScienceLeader.com achieving the highest standard of health for all. Is industry, including CROs, giving adequate attention and proactive plan- ning to guidelines and suggestions, which will surely become an issue at the time of FDA scrutiny, of their clini- cal trials and new drug approval? How many companies are addressing and including "multicultural competency" across their research endeavors neces- sary to make progress? What is cultural competence as it relates to developing new medicines through clinical trials for the three primary stakeholders as guided by the FDA? • For industry, it is a set of con- gruent behaviors, attitudes, and policies coming together in a system, agency, or among profes- sionals enabling those entities to understand and work effectively in cross-cultural situations. • For clinical sites, it is culturally competent physicians and study coordinators providing patient- centered care by adjusting atti- tudes and behaviors to account for the impact of emotional, cul- tural, social, and psychological issues on the disease. • For patients, culture is a set of behaviors taught and inherited as members of a particular group, guiding how to view the world and healthcare, how to experi- ence it emotionally, and how to behave in relation to other people and their disease. The CRO Leadership Awards 2012 Kathleen Drennan Kathleen Drennan is founding president and CEO of TrialAdvance, Inc., established to bring real-world insights of patients and trial sites to the relevant planning, execution, and manage- ment of clinical trials. Racial and ethnic segmentation strat- egies demand a departure from busi- ness-as-usual in the development of clinical trials, especially when envi- sioning trial-site communications, patient education materials, and doc- tor/patient relationships. New mind- sets and skills are needed to address long-entrenched patient skepticism and deeply rooted mistrust about the accuracy of healthcare information, medical institutions, and especially the industry itself. James Gillespie James Gillespie, Ph.D., J.D., M.P.A., is presi- dent of the Center for Healthcare Innovation, president of the National Biotechnology & Pharmaceutical Association, and president of the National Hispanic Life Science Society. INDUSTRY LEADER