The Clinical Trials Transformation Initiative (CTTI) was co-founded by Duke University and the US Food and Drug Administration (FDA).
The organization recently released new recommendations and an online tool, which address pregnancy testing challenges in clinical trials.
Sara Calvert, senior project manager at CTTI, told us the challenges stem from the fact that there is no standard way to plan for and make decisions about pregnancy testing in clinical trials.
As she explained, some research programs use the same testing methods in every trial, such as monthly serum test. Instead of doing this, Calvert said researchers should approach each trial by considering the likelihood of pregnancy in the study population or the risk of the intervention being studied.
“Additionally, there is no common language to discuss differences in opinions on how to conduct pregnancy testing in a specific trial, nor for considering the benefits and burdens of testing plans,” she said.
“These challenges can cause delays in upfront planning and lead to protocol amendments, mid-trial, if unanticipated results occurred.”
Currently, guidance recommends pregnancy testing and contraception to minimize unintentional exposure risks to an embryo or fetus when including females of reproductive age in clinical trials.
“However, details of how to incorporate a pregnancy testing plan within a clinical trial are not provided,” she explained. “And because every trial is different with respect to the likelihood of the study population becoming pregnant, risks of the intervention, and duration of the trial, it is difficult to create guidelines that apply to all clinical trials.”
However, Calvert noted that after CTTI’s pregnancy testing project was underway, the Heads of Medicines Agencies in Europe released more specific recommendations.
The recommendations
CTTI’s multi-stakeholder project team – including patient advocates, FDA representatives, industry members, among others – conducted a survey to better understand current practices, Calver said. It also held an expert meeting to review and refine the findings.
Subsequently, the team developed recommendations and a model to estimate outcomes of different pregnancy testing plans. The model informed a web application tool, which estimates the likelihood of a woman enrolling in the study while pregnant, or becoming pregnant during the study.
“CTTI’s new evidence-based recommendations provide a standard way to plan for and make decisions about pregnancy testing in clinical trials, and also improve communication and transparency with trial participants,” Calvert explained.
The recommendations focus on pregnancy testing plan information that should be included in the study protocol and factors to consider when developing the plan, as well as information that should be shared with patients about pregnancy testing in clinical trials
“We plan to refine our web application based on user feedback to ensure it’s as user-friendly and helpful as possible. We will also work with member organizations to implement our recommendations,” said Calvert.
“Improved pre-trial pregnancy testing planning will result in increased safety and efficiency of clinical trials that include females of reproductive potential.”