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CTTI Project: Pregnancy Testing
The Clinical Trials Transformation Initiative (CTTI) today released new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials.
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JULY 15, 2013 TO JULY 16, 2013
CTTI Project: Pregnancy Testing
Meeting Background:
Designing a pregnancy testing protocol for a clinical trial requires balancing the performance characteristics of a given test, the baseline risk of pregnancy in a given subject population, the potential risks to the fetus from study interventions, and the effect of the testing protocol on overall study implementation in terms of burden to subjects, burden on staff, and direct costs. There are no published data on the consistency of sponsors, investigators, or institutional review boards (IRBs) in applying these criteria to designing and evaluating pregnancy testing protocols. However, anecdotal reports indicate that there is widespread variability.
Development of evidence-based guidance that explicitly considers the level of acceptable risk to suggest appropriate pregnancy testing protocols will ultimately improve protection of research subjects, reduce the risk of unintended fetal exposure, and reduce the workload of sponsors, investigators, IRBs, and other stakeholders in the clinical trial enterprise.
Meeting Objectives:
DoubleTree by Hilton Hotel, Bethesda, MD
Day 1
Day 2
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.
CTTI Project: Pregnancy Testing
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. In this webinar, CTTI unveils new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, to conduct safer, more efficient clinical trials.
The webinar will include:
Most clinical trials exclude pregnant women in order to minimize risk to the embryo or fetus. However, there are currently no specific guidelines for how pregnancy testing should be conducted for female trial participants of reproductive potential, nor how risks should be clearly communicated with them.
In a recent article in PLOS ONE, CTTI shares recommendations developed by experts in academia, industry, and regulatory agencies on pregnancy testing in clinical research. They include the following:
CTTI also developed an online tool to estimate the potential outcomes of different pregnancy testing strategies in the proposed trial population. Together, these resources aim to help research sponsors, investigators, and institutional review boards create and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials.
CTTI’s 2017 Annual Report, released today, celebrates a decade of CTTI impact and highlights our activities and accomplishments over the past year. The report includes reflections from past and present CTTI leaders, case studies on the use of CTTI recommendations and resources, and a glimpse into what lies ahead for CTTI and the clinical trials enterprise.
Since its founding in 2007, CTTI has completed more than 25 projects with the aim of increasing the quality and efficiency of clinical trials. The resulting recommendations were downloaded more than 26,000 times over the past year.
CTTI issued five new sets of recommendations in 2017, many of which draw on recent advances in technology and data sciences to bring about improvements for clinical trials. Read the report to learn more about our latest recommendations and resources, which offer:
As described in the report, these recommendations and resources are being implemented by organizations across the clinical trial spectrum, including IQVIA, monARC Bionetworks, and the Pulmonary Fibrosis Foundation.
As we reflect on the past year—and the past decade—we are grateful for the engagement and commitment of our members, who ensure that we continue to address the latest trends, top barriers, and leading opportunities in clinical research.
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. However, there is little formal guidance on how pregnancy testing should be conducted to prevent unintended exposure, nor how risks should be clearly communicated to women.
CTTI’s new recommendations help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials. CTTI also created the Pregnancy Testing Outcomes Predictor for Clinical Trials, a web application that provides a quantitative method for assessing estimated likely outcomes of different pregnancy testing plans.
A webinar recording is now available detailing the new recommendations and web application, including case examples of their use.
View the webinar recording to learn:
Visit this page for presenter information and to download a copy of the slides.
