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INDUSTRY LEADER Industry Leader THE STAKES ARE HIGH In 2011, the FDA approved the first new drug to treat lupus in 56 years. Lupus disproportionately affects women, and usually develops between ages 15 and 44. Estimates vary on the number of lupus sufferers in the United States, ranging from approxi- mately 300,000 to 1.5 million peo- ple. People of all races can have the disease; however, African American women have a three times higher incidence (number of new cases) than Caucasian women. Two clinical studies with lupus demonstrated the safety and effectiveness of the drug, but patients of African heritage par- ticipating in the two studies did not appear to respond to treatment. The studies lacked sufficient numbers to establish a definite conclusion, so the sponsor agreed to conduct an addi- tional study of people with those back- grounds to further evaluate the safety and effectiveness of this lupus drug. This is a recurring story suggesting that proactive planning of such proto- cols could eliminate having to go back readily available from many sources on the Internet, diabetes affects over 60% underrepresented populations, whereas enrollment of such popula- tions in clinical trials averages about 11% or less. There is no better time than now to take stock of the current burgeoning shift in population demo- graphics and how it will affect the business of new drug development. and do additional studies. The most dramatic of examples is the incidence of diabetes in the United States ver- sus adequate study enrollment repre- sentation. Looking at published data The ability to reach and moti- vate patient communities rep- resenting populations needed to participate in today's clini- cal trials is not insurmount- able; however, it is challeng- ing. Progressive and enlightened companies that embrace clinical trial diversity as an integral part of their research planning and processes will build new bridges with the patient and physician communities. Adopting a multicul- tural competence methodology at the clinical-team level must include aggressive strategy and investment devi- ating from the current norm. THE FINE AR T OF CLINICAL RESE AR CH Local knowledge. Global strength. CHILTERN SERVICES • Early Phase • Global Clinical Development • Late Phase • Biometrics • Medical and Regulatory Affairs • Resourcing Solutions At Chiltern, we're ready to meet new challenges in the world of clinical trials. We understand that in a complex and rapidly changing environment you need a flexible, responsive partner – one that delivers complete trust and quality. We offer global reach through our experienced team comprised of nearly 1,400 people globally, and we've conducted clinical trials in more than 40 nations around the world. Established in 1982, we've grown to become a leading global Contract Research Organization, with extensive experience in contract staffing and conducting Phase I-IV clinical trials across all major therapeutic areas. That's Chiltern – ready to help when and where you need us. Latin America & North America +1 423 968 9533 info@chiltern.com www.chiltern.com Asia Pacific & Europe +44 (0) 1753 512 000 Chiltern is an equal opportunity employer and we ensure that we give full consideration to individual needs for work life balance, personal fulfillment and growth. We are constantly looking for talented individuals at all levels of experience. If you want more information or would like to register your details with us please visit the Careers section of our website. smart phone link The CRO Leadership Awards 2012 LifeScienceLeader.com 33