CINCINNATI, Dec. 13 /PRNewswire-FirstCall/ -- Recent legislation to promote the development of pharmaceuticals for children has led to an increase in the number of pediatric clinical trials conducted in the United States and Europe. Kendle International Inc. , a leading, global full- service clinical research organization, has participated in a number of pediatric trials and regulatory consultancies throughout the world in recent years, including South America, Central and Eastern Europe and the Scandinavian countries. These trials have been focused on the principal areas of pediatric drugs in clinical trials, such as cancer, vaccines, respiratory disease and the treatment of infectious diseases with antivirals and anti- infectives.
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Kendle experts recently commented on the best practices of successful clinical trials within the pediatric market during conferences titled "Overcome Regulatory Hurdles, Recruitment Barriers and Ethical Considerations to Ensure Pediatric Trial Success" Dec. 6 and 7 in Boston, US, and "Paediatric Clinical Trials" Dec. 1 and 2 in Brussels, Belgium.
Melanie A. Bruno, PhD, MBA, Vice President, Regulatory Affairs, presented "Pediatric Data Requests from FDA and Obtaining Waivers." Bruno discussed ways to improve communications with the FDA on specific pediatric trial terms; gain a clear understanding of FDA guidelines and required pediatric data; recognize when a sponsor can amend a written request; and the reasons and rationale for requesting waivers for pediatric trials.
"We advise our customers to discuss the pediatric requirements for their product with the FDA Review Division early on in the process," says Bruno. "The FDA's Written Request procedure is a formal request for pediatric data on a product that could provide meaningful health benefits to the pediatric population. The Written Request also can allow biopharmaceutical companies to obtain the benefits of pediatric exclusivity."
Alan Davies, MD, MRCP, European Medical Director, and a trained pediatrician, presented "Accessing Pediatric Populations in the European Market" and "Successful Completion of Phase II and Phase III Trials." With 20 percent of its population, or 75 million children, aged 16 or younger, the European market is ideal for pediatric studies. Davies discussed the process for filing applications for medicinal products in the European Union (EU) and examined the EU draft Regulation on "Medicinal Products for Paediatric Use" from the EU Commission issued Sept. 29, 2004. The possible role of the new Pediatric Committee -- the first regulatory committee to be managed by the European Medicines Agency (EMEA) -- also was addressed.
"The International Conference on Harmonization recognizes five categories of children: preterm neonates; full-term neonates; infants and toddlers; children; and adolescents, and it is unclear how the Pediatric Committee will interpret ICH E11," says Davies. "If European regulators demand pediatric studies in more than one age group, it would present significant challenges for our biopharmaceutical customers."
With the passage in 2003 of the Pediatric Research Equity Act (PREA) in the United States, all U.S. biopharmaceutical companies now are required to test new drugs for safety, efficacy and dosing information in children. "Because pediatric assessments are expected to become a regular part of the drug development process, it is projected that there will be a steady increase in the number of clinical trials being conducted in the pediatric population," adds Davies. "As a result of Kendle's significant expertise in this area, we are well positioned to capitalize on this growing segment of the clinical development marketplace."
About Kendle International Inc.
Kendle International Inc. is among the world's leading global clinical research organizations. We deliver innovative and robust clinical development solutions -- from first-in-man studies through market launch and surveillance -- to help the world's biopharmaceutical companies maximize product life cycles and grow market share. With headquarters in Cincinnati and more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory and validation services in more than 60 countries. Investor kits are available upon request from Kendle International Inc., 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202, or from the company's Web site at http://www.kendle.com/ .
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