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Our experienced pediatric team addressed regulatory and operational concerns associated with this vulnerable population and recommended practical strategies for planning and conducting pediatric clinical research. Topics included:
- Developing a Feasible Pediatric Plan for PREA/PMDSIA Compliance
- Planning your Paediatric Investigation Plan (PIP) Submission in Europe
- Guidelines for Effective and Appropriate Pediatric Assent & Parental Permission
- Pediatric Considerations beyond Assent
To listen to the archived recordings or download copies of the slides, click here.
Premier Research understands that children are not just little adults and that research must be conducted within this special population. Having conducted more than 75 trials and consulting projects in pediatrics, Premier Research recognizes the nuances associated with these trials, for both the patient and the family, and has the experience and expertise to meet those challenges.
Our pediatric experience is exemplified by our six year contract as the Coordinating Center for the Best Pharmaceuticals for Children Act (BPCA) under the purview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) within the NIH. Throughout this program, responsibilities have included the initiation and launch of the first coordinating center under this act. After Premier Research developed and established all program processes, our role was to provide services to maintain, coordinate and manage multiple networks of clinical centers conducting pharmacologic studies of drugs that may lead to pediatric labeling. The scope of this program has spanned from regulatory submissions through full-service study activities through final study report.
Vulnerable Populations
Through various initiatives including the work we have conducted as the Coordinating Center for NICHD as part of the BPCA, dosing and safety information for pediatric medications has improved in recent years. However, the need for increased pediatric research continues and as seen in legislation passed in the United States and Europe in 2007, has been acknowledged by regulatory agencies.
Special protection must be given to children participating in clinical research. Because their involvement is essential to making improvements in children's healthcare, enrolling a child in a trial is ethically acceptable and necessary. Premier Research has the experience with pediatric trial design and execution to ensure that while children benefit from medical
progress, they are not exposed to unnecessary risks by participating in clinical trials.
Premier Research understands pediatric research and has insight of working with both sponsors and regulatory agencies in developing novel approaches to successfully manage pediatric clinical trials.
Patient recruitment and retention is one of the biggest challenges in pediatric research. Premier Research has the expertise to evaluate the requirements of the clinical trial and develop recruitment plans in partnership with the sponsor and investigative sites in order to meet project timelines. We work with site staff to achieve recruitment goals. Collaborative efforts with the sponsor and site staff include evaluation of study design and impact upon the parents and patient, education of the parents and patients in order to ensure that they understand their obligation to study procedures, and consideration for the needs of the families, such as scheduling visits after school hours.
Premier Research ensures that investigators are fully trained and understand their responsibilities in the parental permission/informed consent and assent process. In order to ensure a successful trial for all involved, it is essential that the investigators provide understandable study information and clearly explain expectations to both the patient and the parents during the parental permission/informed consent and assent process and for the duration of the study.
Premier Research has the experience and expertise to successfully conduct studies in neonates, infants, children, and adolescents. We manage pediatric trials from study design to submission of pediatric data required by regulatory agencies including compliance with the Pediatric Research Equity Act (PREA) and the newly enacted Pediatric Regulation under EMEA. We have experienced in-house regulatory professionals that provide guidance on pediatric development and regulatory strategy. In addition, we can assist with FDA Written Requests for marketing exclusivity.
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