Three questions with…
Chief Product Officer
I’ve been in the life sciences industry for over 20 years. My background is in product management, operational delivery and support of phase III/IV clinical trials.
I have deep expertise in clinical technology systems including IRT, EDC, CTMS, eCOA/ePRO, logistics and digitalization, and I’ve designed and supported countless global clinical trials, phase 1 through 4.
In 2014 my daughter who was 3 years old at the time was diagnosed with type 1 diabetes and it instantly changed our lives.
Like so many other caregivers, my husband and I turned to clinical trials for a solution in order to obtain the best possible care available and we were fortunate to be offered a late phase study evaluating the effect of insulin pumps controlling blood glucose levels in pediatrics.
This technology solution instantly changed and improved our lives overnight and is where my drive for wearable and medical grade devices combined with patient reported outcomes originated. First hand, I witnessed the overwhelming patient benefits as well as the burdens that came with the technology. This is what drives me to ensure as an industry we always focus upon both the patient’s experience and comfort as well as the integrity and validity of the data captured.
What’s the most common misconception about eCOA/ePRO?
ePRO has been around for well over a decade but there are still times when I hear people say “it’s just an electronic questionnaire.” ePRO is so much more than this! It needs to be easy to use, reliable, intuitive and not just a validated instrument converted from paper to electronic for capturing patient responses. ePRO at its heart needs to include engagement. This is how we truly maximize compliance to the protocol. Personally, I would love to see “Electronic Patient Reported Outcomes” be relabeled to Engaging Patient Reported Outcomes!
What actions can our industry take to improve patients’ research experience?
1. ePRO technology vendors should focus truly upon the patient experience by simplifying required study tasks and activities and encompassing personalized workflows with user-friendly interfaces and BYOD modalities. Provisioned mobile devices make life easy for tech vendors but it doesn’t meet the needs of patients who vastly have access to their own smart phone and would choose BYOD over provisioned devices.
2. Don’t look at technologies in isolation from each other. By combining ePRO data with other real-world data sources such as wearables and EHRs, you create a full and holistic picture of the patient’s health and lifestyle, which not only supports the study endpoints but also gives a true indication in to the patient’s wellbeing. A highly experienced cardiologist once told me that if an individual has a stable sleeping pattern and is generally active, that is a reliable indicator that the patient is responding to well to their treatment plan. These words of wisdom have resonated with me all of these years!
3. Combine different engagement mechanisms with ongoing educational materials and collect general participant feedback throughout their study journey to empower participants to better understand their medical condition, actively engage them in the study participation and maximize study protocol compliance.
What eClincial trends should sponsors and regulators learn more about?
In typical phase 2/3 clinical trials there still is a strong emphasis on the importance and role of the site. The adoption of DCT during the pandemic certainly accelerated the need to become more patient-focused and head way was made to adopting patient-centric protocol designs. I still feel more work is needed here however and would love to see a widely adopted approach to patient-centric study designs across all of our industry. The key is to capture input from patient focused SMEs early in the protocol design and build this in to the protocol from the very start.