Participants sought for FDA nonclinical data exchange pilot
The US Food and Drug Administration (FDA) is seeking volunteers to participate in a fit for use pilot program of electronic processing and analysis of nonclinical study data in developmental and reproductive toxicology.The pilot will look at data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data implementation guide for Developmental and Reproductive Toxicology version 1.1 (SEND-DART). FDA announced the pilot 21 October in the Federal Register.
The pilot will continue to build on FDA’s data modernization efforts by supporting standardization of study data submission. “Study data standards describe a standard way to exchange clinical and nonclinical research data between computer systems. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables and a standard way of doing calculations with common variables,” said FDA in announcing the pilot.
Study data standards are already required for study data submitted to the agency’s Center for Drug Evaluation and Research (CDER), according to existing FDA guidance.
The new pilot project follows an earlier pilot that evaluated the use of SEND 3.1 for sample toxicology datasets. This pilot allowed the development of an implementation guide for SEND and evaluation of the capabilities of data validation and analysis tools. The implementation guide was revised following the evaluation.
Currently, data submitted from all studies initiated after 17 December 2016 needs to be formatted as dictated by the FDA Data Standards Catalogs, except for investigational new drug applications, where the requirement applies to studies started one year later, on 17 December 2017.
FDA notes that “the submission of SEND nonclinical datasets is expected to continue to increase in the future.” As more datasets come in, staff involved in the CDISC SEND project will continue to add data elements and terms to the SENDIG-DART.
Just five participants are sought for the pilot and will be chosen at the discretion of CDER, according to the Federal Register announcement. The agency will give priority to nonclinical packages of embryo-fetal development toxicity studies containing data consistent with SEND-DART v1.1. The announcement details the particular use cases that are “most sought out as participants in this pilot;” the list includes pre-bred small animals with the treatment period occurring during major organogenesis, maternal toxicity endpoints, cesarean section endpoints and those addressing gravid uterine weights, among others.
Applicants should note if they are willing to share anonymized data in their letter of interest; the Federal Register announcement also spells out other information that must be provided. “Pilot participants commit to publicly share lessons learned with the CDISC SEND team to ensure that the CDISC SEND standard is improved for the community. Participants may redact any sensitive information as needed to enable sharing FDA feedback with the CDISC SEND team,” said FDA.
Federal Register