The Clinical Trials Transformation Initiative (CTTI) just released new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans.
Among CTTI’s broad recommendations for investigators and sponsors developing a trial protocol:
- It should clearly state the specific purposes of pregnancy testing in the research study.
- It should describe the procedure for handling positive or indeterminate pregnancy tests.
CTTI also has recommendations for investigators when developing a pregnancy testing plan, including:
- Assess the balance of the pregnancy testing plan advantages versus burdens.
- Assess participant burdens regarding the likelihood of false negative results and unintentional embryo/fetal exposure, and the likelihood of false positive results.
- Avoid participant-administered home pregnancy tests in clinical trials.
Recommendations for the pregnancy testing informed consent process include:
- Clearly articulate the extent of knowledge about potential embryonic or fetal risks from exposure to study intervention.
- Clearly explain the limitations of pregnancy test to participants.
The U.S. Food and Drug Administration (FDA) expects clinical trials for drugs to include a population reflective of that which will receive the drug once marketed, which may include females of reproductive potential. However, there are no specific guidelines for how pregnancy testing should be conducted to prevent the unintended exposure of an embryo or fetus to a study’s intervention, nor how risks should be clearly communicated to women.
“The absence of best practices to guide the development of pregnancy testing protocols often leads to prolonged negotiations and trial startup delays—an issue that many people don’t realize exists,” said Pamela Tenaerts, MD, MBA, executive director at CTTI. “Our new recommendations streamline and strengthen the process for determining pregnancy testing strategies for clinical trials, helping to save valuable time and resources.”
Patient advocates were involved in the development process, along with representatives from FDA and other government agencies, academic institutions, pharmaceutical companies, and other key stakeholders.
Author: MIchael Causey