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Q&A: Sharp HealthCare’s Commitment to, and Experience With, Clinical Trials

Five questions for DeAnn Cary, PhD, Director of Research at Sharp HealthCare

Clinical trials are critical to advancing medicine and patient health but participating in them is not easy. Hospitals that serve as clinical trial sites must invest significant time and resources into the process, and one of the most time-consuming elements relates to identifying and enrolling patients in clinical trials.

While many hospitals rely on manual reviews, outdated reports, and other time-consuming methods to find the right candidates, innovative clinical trial sites are turning to new technology that makes the identification and enrollment process much more efficient.

One such organization is Sharp HealthCare, which is using VigiLanz to accurately and quickly identify eligible candidates for clinical trial enrollment. In this Q&A, DeAnn Cary, PhD, Director of Research at Sharp HealthCare, discusses the hospital’s approach to clinical trials and why it began using this new technology to support its research efforts.

 

Tell us about Sharp HealthCare and why it participates in clinical trials?

DC: Sharp HealthCare is a not-for-profit health system based in San Diego that is made up of four acute-care hospitals, three specialty hospitals, three affiliated medical groups, and a full spectrum of other facilities and services.

As a community health system, we firmly believe that it is important to offer cutting-edge treatments to our patients. Clinical trials provide opportunities to access the newest treatments (e.g., drugs, devices, or procedures) that would not otherwise be available to them.

 

How do you choose which clinical trials to participate in and how has your overall participation in trials changed over the past few years? 

DC: When reviewing new trials, we consider several things including our existing portfolio (we typically avoid having competing trials). We also consider whether our patient population is a good fit, as well as whether we have the resources and bandwidth required to meet the requirements and timelines.

We have increased our participation and patient volume in some areas, such as Alzheimer’s. We have decreased our patient volume in other therapeutic areas, such as oncology. Study design and precision medicine has dramatically expanded the inclusion/exclusion criteria making it much harder to find patients who qualify. Precision medicine is definitely better for the patients but more challenging for the teams trying to recruit.

 

What methods have you historically used to recruit patients?

DC: We advertise for some studies, particularly for those which the sponsor pays for all activities associated with the study. In other therapeutic areas, in which insurance is involved (such as oncology), it’s more challenging to advertise because not all potential patients have insurance that the clinics accept. In those instances, the recruitment process is highly manual and primarily consists of chart reviews.

 

How have you improved your clinical trial processes over the years?

DC: The biggest significant improvement in processes has been the use of VigiLanz. This clinical trial solution leverages study-specific inclusion and exclusion criteria to automatically review all patients across a hospital network. It screens the entire patient population to identify eligible patients in real time and provides automated alerts and notifications to key team members when there are eligibility matches.

Key benefits of VigiLanz include the real-time patient identification for studies that have a very short timeline for identification and recruitment (e.g., cardiac and stroke).

VigiLanz has also enabled our small staff of clinical research coordinators to feel confident that they have not missed a single qualified potential research participant. It has also enabled them to focus their time and energies on the patients who meet or nearly meet the study criteria, rather than having to manually review hundreds of patient charts.

 

Do you believe VigiLanz will make Sharp a better candidate for future clinical trials? 

DC: Yes, and we are starting to see some of our sponsor feasibility questionnaires ask if we are using a real-time patient identification platform. As this becomes more common, having a technology like VigiLanz will continue to be critical, not only for our success within particular trials, but in our ability to continue participating in trials in general.

Read this case study to learn more about how Sharp is using VigiLanz to support clinical trial enrollment.