Running modern pharmaceutical and biologic clinical trials is an increasingly demanding and costly undertaking, even under the best of circumstances. These challenges are even greater when done in a pediatric patient population, and present additional scientific, logistical and ethical difficulties to even the most experienced development teams. However, with recent legislative changes, and the needs of the medical community and the healthcare marketplace, Schering-Plough Research Institute as sponsors must now increase their research efforts in this vulnerable population, where quality efficacy and safety information is so very important to the effective care of children. Dr. Flint’s presentation will address the major issues commonly encountered with trials in a pediatric population and look at practical solutions that sponsors can use when planning and conducting these types of studies. The issues being presented will include designing “family friendly” trials, addressing special ethical and logistical issues, way to encourage patient recruitment and retention, understanding fundamental differences within pediatric age groups, and maximizing a team approach to running pediatric drug development programs.
The Global Clinical Trial Operations conference brings together leaders, directors, vice presidents, heads, managers, supervisors, and CROs from all over the world to collaborate and discuss the latest developments in clinical trial operations and logistics and covers clinical trials in emerging markets, first-in-man clinical trials, pediatric clinical trials, material storage, distribution, site selection, patient recruitment and retention, technology in clinical trials and case studies of running global clinical trials.
For more information including a detailed agenda, exhibitor opportunities and registration information visit http://gtcbio.com/
