WOMEN’S HEALTH

For hot flashes and FSD, it is critical to diary design to utilize a scheduled reminder eDiary and episodic (always available) eDiary to maximize data collection.

Innovations in Clinical Trials and Decentralized Clinical Trials for Women’s Health

Women’s Health is a therapeutic area which can greatly benefit from the improvements in data quality captured from use of ePRO and patients reporting their symptoms using an app on their own smartphones. There are several immediate applications for use of ePRO in women’s health ranging from the episodic and real-time/near real time capture of hot flashes in pre- and post-menopausal women through the perceived anonymity of reporting on sensitive topics such as female sexual dysfunction (FSD).

 eDiary Design and Validation

Collection of patient symptoms and events is essential in women’s health clinical trials. The field is rapidly transitioning to fully decentralized clinical trials (DCTs), which includes having patients use an app on their own smartphones to capture both efficacy and safety data. There are multiple advantages to electronic data capture in FSD as studies show that women reported ~50% more sexual encounters when using an electronic versus a paper diary. Further, datasets are more complete as patients are not able to skip questions. Lastly, studies have shown that patients tend to provide more socially desirable responses on paper (i.e., greater sexual satisfaction) than digitally reported data. For hot flashes and FSD, it is critical to diary design to utilize a scheduled reminder eDiary and episodic (always available) eDiary to maximize data collection. Potential solicited and unsolicited AEs and SAEs can be captured in real or near real time. SPRIM Health has successfully developed, validated and successfully implemented several eDiaries in large global women’s health clinical trials.

 Digital Patient Training

There was always a need for patient training in clinical trials and with the expansion of hybrid and DCTs, it is critical to provide interactive digital multimedia training to patients. Training can be provided directly within an app on the patient’s own smartphone and typically contains topics such as study overview and workflow, roles and responsibilities, expectation setting, accuracy and honesty in reporting, importance of compliance and adherence, video vignettes for how to use or how to perform a specific procedure and how to report potential AEs and SAEs. SPRIM Health has developed digital patient training for large global DCTs that has resulted in improved data quality and patient engagement in women’s health studies.