Optimizing Clinical Trials in Academia and Community Oncology

Ira Klein, MD, Tempus Labs, discusses design in clinical trials, touching on current issues such as clinical workflow and operational processes, and the barriers to participating in a clinical trial in community oncology.

Transcript

Hi, I'm Ira Klein, MD. I am the Vice President for Medical Affairs for Payer Relations for Tempus Labs. What I'd like to have the audience understand about doing “just in time” clinical trials in the community setting is that the previous barriers to doing clinical trials outside of NCI and other academic affiliated institutions, is not that these are the type of activities that only academicians and big institutions can do, because the problems to be solved are really those problems of clinical workflow and operational processes. And if a clinical trial can be designed to solve for those clinical workflow and operational process issues, and in addition, account for and solve for the issues of standard contracting, standard staffing requirements, and how to train up to get a clinical trial up and running, then these very valuable tools can be accessible and used by community oncologists.

And we think that should that happen, and actually it is happening within our network in the Tempus Labs family, this will be a tremendous boon for not only the cancer moonshot, but to address the inadequacies of past clinical trials including those social and economic strata of our US population, that we've not seen and that we need to have incorporated into clinical trials, such that the drugs that are developed and the therapeutic regimens that we then accept as effective, reflect the demographics of all of America.

I think when the audience sees that we're really focusing on operations management problems, they'll understand that breaking down what seems to be an insurmountable barrier to participating in a clinical trial then becomes a series of tasks to be problem solved one at a time, they'll understand that with some help, they can do it. If they understand what they're up against at each step in the game of participating, enrolling, and then actuating a clinical trial, they'll then make that available to their patients, because as was said at the symposium, those practices that enroll at least 2% to 3% of their patients in clinical trials, those practitioners actually do a better job of caring for their other patients.

And I think if I was to be a patient, I would want to have clinical trials available. And the fact that much of America doesn't live in densely populated urban areas, or have the wherewithal to understand where the current clinical trials are being done, this now gives them the ability in underserved, rural, midsize city locations, to participate in this very important set of scientific processes that not only give them a chance for survival and better quality of life when standard options are not available, but also contributes to the database in a way that helps the next cancer patient.