The Duke Clinical Research Institute (DCRI), the largest academic clinical research organization in the world, is partnering with Kaplan EduNeering, a leading provider of compliance and knowledge-management solutions, in a novel educational program to address one of the most vexing problems encountered when conducting clinical trials abroad - the absence of a ready and fully trained professional infrastructure to get the work done.
“Sponsors will be able to conduct site recruitment by filtering the database of globally certified personnel by location, areas of practice, years of experience, and other criteria”
Sponsored research is leaving U.S. shores at an astonishing pace, and concerns about patient safety and data integrity are growing in parallel. A recent Duke study noted that since 2002 the number of active FDA-regulated investigators based outside the U.S. has grown fifteen percent annually, whereas the number of U.S.-based investigators has declined by more than five percent.
"We don't see that trend changing," said Robert Harrington, MD, director of the DCRI. "However, what we do see is an increasing demand that studies be conducted according to the highest standards possible. To assure this global need is met, we now have a robust and comprehensive education and training program that can guarantee sponsors and participants alike an appropriately skilled workforce."
The initial program, called Clinical Research Education and Training via eLearning, or "CREATe," is a set of 28 computer-based, interactive learning modules designed for the novice investigator and key research personnel seeking a strong foundation for a career in clinical research. The content reflects a U.S. regulatory framework but is customizable to reflect local cultural values and customs.
According to Harrington, "the DCRI has collaborated with both university-based and private-practice colleagues around the world for many years. In some areas of the globe, such as India and China, the desire to participate in large clinical trials is strong, but there is a gap in training among the clinical research work force."
"From our experience in providing online training to thousands of clinical research professionals globally, we've learned that the quality and consistency of the content is the key to effectively trained personnel," said Ryan Carpentier, Chief Operating Officer and Managing Director - Asia, Kaplan EduNeering. "We're excited to partner with the DCRI, and help deliver the knowledge of their world-renowned faculty and their global experience across multiple therapeutic areas."
"This deep, global clinical research knowledge is being transformed into an engaging online clinical research learning experience that can be localized and personalized," Carpentier added. "The DCRI has made it clear that this program must address the unique clinical regulatory requirements of specific countries. Learners will be able to leverage Kaplan's global reach, including Kaplan EduNeering offices in Hong Kong and Beijing, to expand the online experience into face-to-face events, such as continuing education opportunities."
Harrington says the training program will be valuable for both professionals who are already working in the field and those who seek entry into the world of clinical trials. "We see many companies as well as the NIH interested in opening studies in India, for example, but the Planning Commission of India estimates a shortage of 30,000 to 50,000 trained personnel," said Harrington. "CREATe offers a way to develop skills among large numbers of learners efficiently, thoroughly, and in a culturally sensitive manner."
Initially, the training modules will be available through company sponsorship. Students who complete the coursework will earn a certificate from the DCRI, and site metrics will be maintained in a database that will be accessible to sponsors seeking appropriately educated personnel and research-ready locations.
"Sponsors will be able to conduct site recruitment by filtering the database of globally certified personnel by location, areas of practice, years of experience, and other criteria," said Carpentier. "The clinical researchers, in effect, receive a portable DCRI-global certificate that provides them with recognition across multiple participating sponsors." The program builds upon the strengths of both institutions. The Duke Clinical Research Institute is a global leader in clinical research, conducting clinical studies in more than 60 countries. Kaplan, a pioneer in education for the past 70 years, provides training to more than one million students at over 600 locations in 30 countries around the globe.
"Global research requires global solutions. Our belief is that educating a global workforce is good for patients and good for science," said Harrington.
SOURCE Duke Clinical Research Institute