What is PEDSnet?
PEDSnet is a community of patients, families, clinicians, scientists, and healthcare system leaders who work together in a distributed learning health system (LHS) that is dedicated to discovering and implementing new ways of providing the best care and ensuring the best outcomes most efficiently. It is producing reusable and expandable governance, logistical, informatics, regulatory, scientific, and training resources, organized as a Pediatric Research Commons. PEDSnet has ratified important policies that lay the groundwork for the network’s governance. These include a Steering Board Charter, Data Network Policy, and Single Institutional Review Board Policy. PEDSnet institutions have entered into a Single IRB Master Reliance Agreement and Data Use Agreement, which all promote efficiencies in the ethical oversight of a multi-institutional pediatric, clinical research network. Across its 8 founding institutions, PEDSnet has created a 7-year, analysis-ready database for 5.3 million children.
Why was PEDSnet created?
We believe that our health system can be better at meeting the needs of children who suffer from health conditions. Perhaps the biggest challenge results from the difference between children’s optimal health, achieved by applying the most effective healthcare when and to whom it will be most beneficial, and children’s actual health. The size of this gap is inversely related to the quantity and quality of evidence that informs clinical decision-making and the capacity of health systems, patients and families to work together to ensure that what is known is applied. Lack of scientific evidence from clinical and health services research leads to gaps between optimal and actual health.
In its current state, pediatric research generates evidence too slowly and at too high a cost. It does not answer the questions that are often most important to patients, families, and health system leaders or ensure that when new knowledge is produced it is translated into practice. Too often children must rely on hand-me-down evidence from adult studies. Because many pediatric health conditions are uncommon or rare, no single institution has a sufficient number of patients to produce generalizable research that can directly inform shared clinical decisions that are made by parents, children and youth, and their clinicians. A persistent challenge for pediatric research is the lack of a national interconnected, multi-institutional infrastructure.
PEDSnet was formed to improve the health of the nation’s children by creating a multi-institutional network of health systems that collaborate with patients, families, and clinicians to identify and answer the most important research questions rapidly and inexpensively with results quickly implemented to inform decision-making about the best treatments to improve the health of each child.
Are there conditions of focus within PEDSnet?
PEDSnet is a comprehensive data resource that is intended to be leveraged for all types of conditions. However, PEDSnet engages condition specific networks for collaborative research activities, and furthermore will also be serving as a platform for cross cutting collaborative research groups, where entities interested in common research areas can convene, connect, and collaborate.
What are features of a competitive study proposal application?
A successful research proposal should capitalize on available PEDSnet resources. The proposal should clearly address why the study is best suited to be conducted within PEDSnet versus other networks or settings.
Must a study only reflect a collaboration of the current PEDSnet institutions or networks?
No, a study could be conducted in collaboration with non-PEDSnet entities. The Principal Investigator could come from an institution outside PEDSnet, but he/she would need to have at least two PEDSnet partners, i.e. Co-PIs, located within a PEDSnet institution or network.
Is it sufficient to note intent and willingness to collaborate with other entities (e.g., other PEDSnet sites)?
Yes. We expect that institutions may formalize relationships after the development of a brief research proposal. Please note that to be considered a PEDSnet study, the study must involve the collaboration of two or more PEDSnet institutions or networks.
Do devices need to be FDA approved to be proposed in a comparative effectiveness trial for PEDSnet?
Proposals that include the evaluation of surgical and medical devices do not require FDA approval. We expect that PEDSnet would support research to evaluate the effectiveness of medical and surgical devices for children.
If the proposal uses Electronic Health Record data, and the request is for a dataset only, will there be a charge for a data extract?
Yes. PEDSnet has established a fee structure to support the operating costs of the PEDSnet Management Office and the Data Coordinating Center. The data access fee takes into consideration the nature of the funding opportunity and the complexity of the requested data set.
Should proposals only reflect the PEDSnet Common Data Model (CDM) v2.4- and its respective data elements?
The PEDSnet CDM (currently v2.4) should serve as a starting point for investigators to understand data available in the PEDSnet data network. The PEDSnet CDM is designed to expand over time with additional domains and data elements. The network is developing criteria by which new data domains and elements will be considered for expansion. Data requests that are limited to the CDM will reflect the most economical data access fees.
We expect and welcome investigators to propose studies that focus on the use of data elements not currently included in the data model, however the collection of data outside the current CDM could only be supported via external funding sources.
How can I engage with PEDSnet?
PEDSnet is now open for business. Please refer to our Access PEDSnet page to find out more.