Dataset Information

Exploring current read-across applications and needs among selected U.S. Federal Agencies.

ABSTRACT: Read-across is a well-established data gap-filling technique applied for regulatory purposes. In US Environmental Protection Agency's New Chemicals Program under TSCA, read-across has been used extensively for decades, however the extent of application and acceptance of read-across among U.S. federal agencies is less clear. In an effort to build read-across capacity, raise awareness of the state of the science, and work towards a harmonization of read-across approaches across U.S. agencies, a new read-across workgroup was established under the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). This is one of several ad hoc groups ICCVAM has convened to implement the ICCVAM Strategic Roadmap. In this article, we outline the charge and scope of the workgroup and summarize the current applications, tools used, and needs of the agencies represented on the workgroup for read-across. Of the agencies surveyed, the Environmental Protection Agency had the greatest experience in using read-across whereas other agencies indicated that they would benefit from gaining a perspective of the landscape of the tools and available guidance. Two practical case studies are also described to illustrate how the read-across approaches applied by two agencies vary on account of decision context.

SUBMITTER: Patlewicz G

PROVIDER: S-EPMC6814248 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Exploring current read-across applications and needs among selected U.S. Federal Agencies.

Patlewicz Grace G Lizarraga Lucina E LE Rua Diego D Allen David G DG Daniel Amber B AB Fitzpatrick Suzanne C SC Garcia-Reyero Natàlia N Gordon John J Hakkinen Pertti P Howard Angela S AS Karmaus Agnes A Matheson Joanna J Mumtaz Moiz M Richarz Andrea-Nicole AN Ruiz Patricia P Scarano Louis L Yamada Takashi T Kleinstreuer Nicole N

Regulatory toxicology and pharmacology : RTP 20190510

Read-across is a well-established data gap-filling technique applied for regulatory purposes. In US Environmental Protection Agency's New Chemicals Program under TSCA, read-across has been used extensively for decades, however the extent of application and acceptance of read-across among U.S. federal agencies is less clear. In an effort to build read-across capacity, raise awareness of the state of the science, and work towards a harmonization of read-across approaches across U.S. agencies, a ne ...[more]

PMID: 31078681

Similar Datasets

Project description:BackgroundHousing First has become a popular treatment model for homeless adults with mental illness, yet little is known about program participants' early experiences or trajectories. This study used a mixed methods design to examine participant changes in selected domains 6 months after enrollment in a Canadian field trial of Housing First.MethodsThe study sample included 301 participants receiving the Housing First intervention at the Toronto site of the At Home/Chez Soi project. This study used a pre-post design to compare quantitative 6-month outcome data to baseline values in key domains and multivariate regression to identify baseline demographic, clinical or service use variables associated with observed changes in these domains. In addition, qualitative data exploring participant and service provider perspectives and experiences was collected via stakeholder interviews and focus groups, and analyzed using thematic analysis.ResultsThe majority (60 to 72%) of participants followed the expected trajectory of improvement, with the remaining experiencing difficulties in community integration, mental health symptom severity, substance use, community functioning and quality of life 6 months after program enrollment. Diagnosis of psychotic disorder was associated with a reduction in quality of life from baseline to 6-months, while substance use disorders were associated with reduced mental illness symptoms and substance use related problems and an improvement in quality of life. Participants housed in independent housing at 6-months had greater improvements in community integration and quality of life, and greater reduction in mental illness symptoms, compared to those not independently housed. The quality of the working alliance was positively associated with improvements in physical and psychological community integration and quality of life. Qualitative data provided a unique window into the loneliness and isolation experienced by Housing First participants, as well as problems related to substance use and a need for life skills training and support.ConclusionsAdditional strategies can help support Housing First participants in the early stages of program participation and address potential causes of early difficulties, including lack of life skills and social isolation. This study highlights the importance of early and ongoing evaluation, monitoring and program adaptations to address consumer support needs.Trial registrationCurrent Controlled Trials ISRCTN42520374.

Dataset Information

Exploring current read-across applications and needs among selected U.S. Federal Agencies.

Publications

Exploring current read-across applications and needs among selected U.S. Federal Agencies.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets