The PDS team frequently presents scientific posters at industry events worldwide. Visit this page often for the latest insight into key industry topics.
SEND Submissions — Quality review by QA — Yes/No?
With FDA mandated electronic data submissions in SEND format for NDA, ANDA and BLA supporting Single Dose, Repeat Dose and Carcinogenicity studies, starting after December 17, 2016, how confident are you that datasets compiled into a submission package are complete and accurate for all studies? The purpose of this poster is to share SEND experiences concerning dataset accuracy, and the possible role of QA in the submission process.
Use of R Script to Create Trial Summary (ts.xpt) Domains for Nonclinical SEND Studies
The "Study Data Technical Conformance Guide" for electronic submission of study data requires a Trial Summary (ts.xpt) dataset file even for legacy studies. The Nonclinical Script Assessment Project (part of the PhUSE"Nonclinical Topics" working group) was created to explore computer scripts to help with SEND data analysis. As part of this effort, an "R" script was created and shared that generates the ts.xpt to meet this requirement. In addition, this project is also collaborating on other scripts to analyze SEND datasets.
Actions for FDA SEND: What Pathologists/Toxicologists Need To Know
The Study Data Tabulation Model (SDTM) serves as the model for clinical study data. SEND is the implementation of SDTM for nonclinical studies and specifies the rules for standardizing nonclinical study data. Both SEND and SDTM require the mapping of controlled terminology (CT), and dealing with pathological terms will be a huge challenge. To create the SEND data set for a study, input (source) electronic pathological data is transferred directly to the SEND conversion tool, TranSEND®, using Ascentos® PathData version 11 (made by PDS) for immediate automatic conversions.
PP26 FDA SEND Submissions: Does the Pinnacle 21 Open Source Community Validator Predict Findings from FDA’s SEND Validators?
The Pinnacle 21 Community SEND validator is an open source tool used by many sponsors to evaluate SEND datasets for compliance to CDISC's SEND standard. An appreciation of how well it predicts results from the different SEND validators used by FDA SEND at this point in time is important. Our poster presentation summarizes and compares FDA SEND validator findings to Pinnacle 21 SEND validator findings (current version, 2.1.0) for several recent FDA SEND repeat-dose toxicology submissions.
Strategic Approaches to the Use of SEND Controlled Terminology
Starting in December 2016, SEND (Standard for Exchange of Nonclinical Data) will become mandatory for nonclinical FDA submissions. One requirement of SEND is the mapping of specified study terms to CDISC SEND controlled terms (CT). However, the SEND model itself also requires inclusion of original terms recorded by pathologists and other scientists, in addition to the mapping of these terms to SEND CT. This dual representation provides sponsors with strategic options.
Template, User Guide, and Examples for Nonclinical Study Data Reviewer’s Guide for SEND Submissions
According to FDA’s Study Data Technical Conformance Guide v2.2 (June 2015), preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. An SDRG template, completion guidelines, and examples for clinical studies have been available since May 2013.
Challenges and Solutions for Mapping Pathology Data to SEND
Based on our experience creating SEND datasets for FDA submission, we can group SEND mapping challenges for pathology into several patterns.
FDA SEND in Non-US Countries Responses to the Standard for Exchange of Nonclinical Data (SEND) in Non-US Countries
The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions.
Comparison of FDA and OpenCDISC SEND Validator v1.4.1 Rules
A rule-by-rule comparison was made between FDA and OpenCDISC v1.4.1 SEND validation rules to determine which were present in the FDA set but not in OpenCDISC, which only in OpenCDISC and which in both. This analysis was a first step in a process to extend the OpenCDISC validator to also include FDA validation rules.
SEND Architecture Facilitates Harmonization and Aggregation of Data From Different Organizations/LIMS
Toxicology studies in today’s business environment involve multiple testing sites, LIMS and/or departments. PDS offers a software architecture for SEND that accomplishes the aggregation, harmonization and translation of data from different sources into one complete dataset including all XPTs, define files and validation report(s).
Selecting a CRO for Creating and Integrating SEND Datasets From Multiple Organizations
Creating and integrating SEND datasets from multiple CROs and LIMS can be a complex process requiring good partnerships and upfront understandings between sponsors and CROs. The Interorganizational SEND (I-SEND) Project Team within the FDA/PhUSE Nonclinical Working Group has developed a guide to help establish CRO capabilities, logistics and sponsor expectations.
The Occurrence of Microscopic Vacuoles in Toxicology Studies With Marketed Pegylated Proteins Is Associated with High Doses, High Clinical Multiples and Accumulation
The Food and Drug Administration (FDA) Biologics License Applications (BLA) provided reviews for nine of 11 pegylated proteins marketed in the United States. These proteins were analyzed to obtain a more complete understanding of microscopic vacuoles in nonclinical toxicology studies,