Understanding real-world evidence generation from point-of-care trials: an interview with Kraig Kinchen, Eli Lilly
In this interview we speak with Kraig Kinchen, Associate Vice President Value, Evidence and Outcomes, Diabetes Business Unit at Eli Lilly and Co., USA about point-of-care (POC) clinical trials and how they can be used to support real-world data (RWD) and real-world evidence (RWE) generation for clinical and regulatory decision-making.
Please could you introduce yourself, your organization(s) and give a brief overview of your career to date?
My name is Kraig Kinchen. Approximately half of my 20-year career at Eli Lilly has been spent in roles focused on RWE. The other half has been spent in clinical development, mostly in medical leadership roles. Since February 2022, I have served as Associate Vice President for Value, Evidence and Outcomes in the Diabetes Business Unit.
Can you tell us more about POC clinical trials and how they are used in RWD and RWE?
In health outcomes research, researchers primarily use observational study approaches to leverage RWD. Often utilizing large claims databases or electronic medical record databases, observational researchers employ analytic techniques to generate evidence on topics including the following: treatment patterns; the impact of social determinants of health on patient outcomes; health care costs associated with the treatment of medical conditions; and the comparative effectiveness of medical interventions. POC trials offer a different approach for researchers to leverage RWD. Rather than only observing care, researchers employ an interventional approach in which participating patients and healthcare providers in usual care settings agree to be assigned to one or more treatment options. For example, patients going to see their doctors in their usual clinical practice settings may agree to be randomized to one available treatment versus another available treatment. Patients may be followed as they normally would be in clinical practice. Treatment outcomes may still be assessed by leveraging RWD.
In what circumstances would stakeholders consider using POC clinical trials for RWD? Can you provide any recent examples?
Increasingly, researchers are using advanced analytic techniques to control for confounders and draw conclusions in observational research. However, there may be cases in which researchers would prefer to address the issue of confounders by randomizing patients to interventions in a POC design rather than using an observational study approach. Examples might include cases in which important confounders are poorly captured in a database and/or the expected effect size is relatively small.
The VA Diuretic Comparison project is an excellent example of a well-designed POC trial. The recent New England Journal of Medicine publication of this study should bring increased attention to POC trials.
You’ve recently been part of the Duke-Margolis RWE Collaborative Point-of-Care Trials Working Group that published a White Paper in May 2022. Can you tell us more about this?
The Duke-Margolis Center for Health Policy has done an excellent job in helping to focus the attention of multiple stakeholders on the potential role that POC trials can play in improving healthcare. Input for the White Paper came from expert opinion from a Duke-Margolis working group as well as from discussions at an October 2021 POC trial meeting. I am hopeful that the researchers and other interested stakeholders will continue to build on this work.
What challenges remain to ensure RWD collected through POC trials can be deemed fit-for-purpose from a regulatory perspective?
From a regulatory perspective, the challenges of RWD collected through POC trials are very similar to the challenges of RWD collected for observational studies. The FDA’s draft guidance documents on RWD and RWE detail a number of those challenges. As the field continues to gain an understanding of these challenges and puts forward potential solutions, the ability of researchers to use POC trials for regulatory purposes should improve as well.
It’s been 10 years since POC trials began. What developments would you like to see in the next 5–10 years to advance this field?
First, the case for conducting POC trials must be made convincingly to both sponsors of research and to healthcare systems. Describing POC trials in a way that resonates with healthcare systems will be critical to moving groups to invest the time, energy, and economic resources necessary to move POC trials forward.
Second, when we think about extremely busy healthcare providers participating in such trials, proponents of point-of-care trials will need to devote significant attention to decreasing the potential burden of conducting research involving providers and patients in clinical practice settings.
Third, improvements in technology that facilitate recruitment and randomization of patients should enable more POC trials to move forward.
Disclosures:
The opinions expressed in this feature are those of the interviewee and do not necessarily reflect the views of The Evidence Base®.
