Featured Solution: Pregnancy and Breastfeeding Landscape Assessment
We leveraged the Pregnancy and Breastfeeding Landscape Assessment to completely revise our “Clinical and Post-market Pregnancy Follow-Up” forms into a single, streamlined form. The pregnancy follow-up form is used globally to obtain follow up information on the pregnant mother and the course and outcome of the pregnancy. This form is used in both clinical trials and all post-marketing case types.
The Landscape Assessment helped us determine what data points we should keep and which ones we could remove because they were duplicative or unnecessary. After our review, we reduced the form from five to three pages, representing a 40% reduction in data points (questions). A shorter and more streamlined document will help us:
- Elicit more participation from site investigators, participants, and healthcare practitioners (HCPs) in their form submissions so that we capture important safety data.
- Ensure more compliance in completing the form in clinical trial settings so that participants are protected and to maintain data quality.
- Reduce the burden and time of filling out a form to improve the end-user experience.
The project timeline to overhaul the follow-up form was significantly reduced because of the hours of research time saved by using the Landscape Assessment. The comprehensiveness of the document provided a significant jumpstart to the team’s research and gave the team confidence that all relevant requirements were considered in the updated form.
By creating a more streamlined form, we expect this results in the receipt of more follow-up information and, subsequently, better safety assessment/oversight of our products during pregnancy. We use follow-up data to update our product inserts and labeling. For products with no pregnancy information, and through the data we gather through these forms, we can better update our inserts and labeling. This information is critical to know for the care provided to pregnant and breastfeeding women and to ensure their safety.