RBQM Ops 2022 - The participant journey in DCTs

The participant journey in DCTs

SUMMARY KEYWORDS
participants, consent, clinical trial, trial, data, adverse events, patient, early, qm, site, rbqm, risk, included, facilitate, protocol, improve, clinical,

DUNCAN HALL:

The patient journey is a phrase you'll hear banded around in lots of different forums. But what does it really mean in the context of risk-based quality management? Our next speaker has a unique perspective on that topic, so I'm delighted to introduce Ingrid Oakley-Girvan from Medable. Welcome Ingrid.

Ingrid has over 15 years of relevant industry experience, including time as a consulting assistant professor at Stanford University, and also as a member of the Stanford clinical trial Scientific Review Committee. For the last seven years, Ingrid's been the SVP of research and strategy at Medable where her goal has been to help digitize and decentralize the clinical trial process. With over 30% of participants dropping out of clinical trials and only 2% of eligible patients participate in clinical trials, improving the patient experience from reducing burden on the patients are absolutely vital goals for our industry. So, without further ado, I'm going to hand over to Ingrid, thank you so much.

INGRID OAKLEY-GIRVAN:

Thank you, Duncan for that lovely introduction. I'm excited to talk today about the patient journey and the clinical trial in which components are not all necessarily physically completed at a site. Doing this successfully, just as when studies are conducted exclusively at a site means we need to plan for risk mitigation, including adverse events and collecting high quality data.

Before we get into some details, I show this slide just as a reminder, I also want to clarify some terminology, whether we call the trials decentralized or patient-centric or direct to patient. The bottom line is we are making use of digital health technology and innovative operational strategies to improve accessibility for participants. We want to enable participation by busy people, sick people, and people that don't live close to a site.

So how do we do this. We harness the power of technology to reach people in the comfort of their home, or to reach them as close as possible to their neighborhood. From an operational standpoint, we are all part of the solution. And we all want to honor participants starting with their safety and making sure that the data collected is of high quality and can be used in regulatory submissions. Today, I'm going to focus on digitally captured data that is available in real time when we begin to decentralize components of clinical trials. I'll then highlight aspects of the participant journal using some specific examples. As we create protocols that have components that do not require participants to travel the sites, I know there is concern about safety monitoring and data quality. As a principal investigator myself I recognize these concerns are at the forefront of our minds. But this holds true whether we are conducting an in-person hybrid or fully remote trial. It holds true whether we are collecting data on paper, or through technology and digital tools such as wearables and connected sensors, or other eCapture methods...