One of the biggest challenges facing clinical trial sponsors and investigational sites centers on the efficient identification, recruitment and ongoing retention of sufficient numbers of participants, whether they be patients in a novel therapeutic study to volunteers for new vaccine studies. For the former, that is the finding and retaining of patients for therapeutic-focused research, a growing trend, points to the concept of clinical research as a care option. That is, that various processes, workflows and clinician-facing decision tools can be developed to help promote more awareness, access and ultimately participation to research itself. The modifications to system and process raise therapeutic area implications—that, is they must emphasize more awareness and access by therapeutic area and specific condition. Recently, a professor of medicine from the University of California, San Francisco (UCSF), presented a clinical facing decision tool to help generate more awareness and access in the area of prostate cancer. Presented at the virtual 2021 ASCO Genitourinary Cancers Symposium, Dr. Hala Borno, a medical oncologist, shared how at UCSF they designed a novel technology solution that matches the specific patient with all available clinical trials.
Open and Available
The tool, available here, enables clinicians to enter patient attributes necessary for prostate cancer trials with the result being a generated list of eligible clinical trials for that specific patient. Importantly, other data such as the associated clinical research coordinator as well as other particularities impacting trial eligibility also results with the output, reports the Journal of Clinical Pathways video.
Patient Centric Report
This clinical decision support tool was designed with the patient in mind. When an individual discovers they have a prostate cancer diagnosis, many key emotions manifest; fear, first and foremost, but also pain and sadness that this event is real and present. Information becomes power as the patient, working with their provider, seeks to make the best possible decision to help them improve the odds of beating back such a cancer.
Clinical research, especially in fields such as cancer, becomes a valid treatment pathway in some cases. That the physician and patient are armed with such a tool, one that can generate a comprehensive report involving the various attributes necessary for trial participation, points to the game-changing world of research as a care option. The physician becomes privy to important information in light speed—the proportion of patients with oligometastatic disease vs. hormone-sensitive disease vs. hormone-resistant disease while characterizing their prior treatment exposures, reports Journal of Clinical Pathways.
Supporting Analysis for Industry & Investigator-Initiated Trials
Such a tool, when integrated with the electronic medical records in a large academic medical center, such as UCSF, also can establish a value-added way to access what is typically difficult to come by data to support both industry and investigator-initiated trials. For example, if a center such as UCSF is considering participation in an industry trial, analysts could use such a tool to investigate true feasibility based on not only population of patients but also specific patient attributes based on the study protocol’s inclusion and exclusion criteria for instance. Such a tool can become indispensable and can expand into other areas of oncology, for example.
In fact, that is exactly what will occur. As Dr. Borno shares, UCSF will expand the use of such a tool to include other tumors and the clinical trials relevant to additional urologic malignancies. Ultimately, she reports, “…it will be a model that can be applied across the entire oncology sector and really change the ways in which we communicate trial availability within our health system.”
Call to Action: These kinds of tools will grow in numbers, by institution, therapeutic area and even across systems as the market ultimately rationalizes and brings efficiency to various approaches of matching research to patient needs.