3 - Specific competencies and capacity to provide export advice
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Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Duke Clinical Research Institute (DCRI) |
|
| Number of peer reviewed publications in the last 5 years | 535 | http://www.ncbi.nlm.nih.gov/ pubmed |
| Number of competitive grants obtained in the last 5 years | Publications of pediatric research group members | |
| Access to expert groups | Yes | Our clinician-researchers can seek and rely on their colleagues expertise in the DCRI (we have 200 clinician researchers) and throughout Duke University (https://duke.edu/) and the Duke University School of Medicine (https://medschool.duke.edu/). Our pediatric clinician-researchers are also active members of many outside professional organizations, specifically: the American Academy of Pediatrics, the Infectious Diseases Society of America, and the Society for Pediatric Research. |
| Capacity to answer external scientific questions | Yes | DCRI’s external website is located at: https://www.dcri.org/. But research at DCRI covers many areas in addition to pediatrics and our expertise in these areas can overlap (e.g., safety surveillance or biostatistics). All of the trial services DCRI offers may be found at: https://www.dcri.org/our-services The faculty leader for DCRI’s Pediatric Research Group is Daniel K. Benjamin Jr., MD, PhD, MPH DCRI Faculty Associate Director, Kiser-Arena Distinguished Professor of Pediatrics. Dr Benjamin’s contact information is accessed through the DCRI website, therapeutic area: Pediatrics https://www.dcri.org/our-research/pediatrics Dr Benjamin is also the Principal Investigator for the Pediatric Trials Network, a $95 million, 7 year contract with the National Institute of Child Health and Development (NICHD). In addition to Dr Benjamin, the DCRI PTN leadership team includes P. Brian Smith, MD (our proposed primary contact person for Enpr-EMA) Michael Cohen-Wolkowiez, MD, who has lead our PK studies, and Katherine Berezny, MPH, the program manager. The NICHD awarded a contract to Duke Clinical Research Institute (DCRI) to establish the PTN. The main objective of the PTN is to provide an environment and an appropriate infrastructure for conducting safe and effective pediatric clinical trials for the Best Pharmaceuticals for Children Act (BPCA) drug development program and for performing ancillary activities in support of these trials. The PTN conducts pediatric clinical drug trials in a variety of therapeutic areas, including but not limited to cardiovascular diseases, cancer, infectious diseases, gastroenterology, respiratory diseases, neonatology, and medical devices. PTN website: http://pediatrictrials.org/ |
| Site feasibility | Yes | |
| Participant recruitment | Yes | |
| Budget calculation for studies | Yes |