POPS - Information for Providers

       

POPS Study Overview

This study is an opportunistic pharmacokinetics (PK) study in collaboration with the Pediatric Trial Network (PTN) and Duke Clinical Research Institute (DCRI). This study is the first clinical trial to be initiated as part of our IDeA States Pediatric Network, and our Nebraska site will begin enrolling patients in the coming weeks. However, this study has been successfully up and running at Duke since 2011, resulting in 6 publications and 4 drugs submitted to the FDA.

As you know, many drugs used in pediatric patients are prescribed off-label and don't have official FDA approval for use in kids. The goal of this study is to gather PK data from kids who are already being prescribed these medications per standard of care. This information will help in determining more accurate pediatric dosing, as well as obtaining safety information for FDA approval. There are currently 32 "drugs of interest" (DOIs) from multiple therapeutic categories that the study team will use to identify potential subjects. If consent/assent is obtained, we would draw an extra study tube alongside their other regularly-scheduled labs, from hours up to 28 days after a dose has been given. For a certain few medications, we may also collect urine, CSF, or other body fluids if they are available. However, none of these samples would be collected as a separate law draw, so it is considered a minimal risk study.

Please visit the PTN POPS website for more information, including current study statistics, news, and publications.

If you are interested in being listed as a co-investigator on this study, please contact us for more information! 

New Opportunity for Investigators!


The ISPN recently received news about an exciting opportunity available to our sites. As mentioned above, the POPS study aims to shrink the gap between pediatric and adult dosing information available to prescribing pediatricians. The PTN has launched an official process by which new drugs of interest (DOIs) can be proposed. While evaluations of DOI submissions won't begin until spring of 2019, we wanted to pass on the information so that colleagues may begin thinking of potential drugs of interest and gathering support for their inclusion in the study.

There are 82 DOIs that have already been studied, or have plans to be included in the future, so please review the list of past DOIs before moving forward in the process. In addition, you may wish to review the Best Pharmaceuticals for Children Act (BPCA) Priority List, which identifies current therapeutic needs in the medical treatment of children and adolescents. Each calendar year, new therapeutic areas are selected for discussion and further prioritization. 

 

Drug of Interest Proposal Process:

  1. Download DOI Proposal Form
  2. Submit completed form to the NPCTU or directly to DCRI by December 31, 2018.

Please feel free to contact us if you have any questions or are considering a DOI submission. The NPCTU team is happy to help with the submission process!