This week we welcome Kyle Holen to Trial by Data to discuss how clinicians can reduce patient burden, the feasibility of siteless trials, and the patient pipeline. We also touch on the FDA’s involvement in building the clinical trial of the future.
Kyle trained as a medical oncologist at Columbia University and Memorial Sloan Kettering Cancer Center, where he began his career treating patients with GI tumors at the University of Wisconsin. There, his research interests included early phase trials and novel therapies for GI and neuroendocrine tumors. He left academia to pursue drug development at AbbVie in 2009. He is currently the Head of the Development Design Center, a center that assists clinical teams with their programs and trials using big data/predictive analytics and innovative strategies.
You can find him on Linkedin here.
Each episode, we pull out some of the key themes of the conversation for our listeners.
Here are the highlights from our conversation with Kyle Holen:
How can we assess patient burden? If the patient burden is too high in a clinical trial, clinicians run the risk of low engagement or frustrated participants. Currently, there is no standardized — or even systemized way — to assess patient burden. Kyle and AbbVie are hoping to change this by creating a consistent patient burden scoring metric. By assessing clinical trial procedures and design choices, the hope is that AbbVie will be able to determine an average patient burden score and then take steps to reduce any unnecessary friction in trial design. It’s a win-win situation. If you can reduce the burden of the patient, you reduce the burden of the sites
The feasibility of direct to patient clinical trials. Currently, less than 8% of the oncology population is involved in clinical trials. However, this can change if we find better ways to get people to participate. By moving clinical trials into the home, we reduce the barrier to entry and encourage greater participation in clinical trials. At the same time, we need to address the concerns of appropriate oversight in remote trials. Siteless trials have excluded the patient-doctor relationship and excluded the academic centers from participating in research. We need to find a balance and realize an effective sub investigator model. The solution may simply be determining which types of studies are a good fit for the siteless approach (large studies, observational studies) and which are not.
We need to find an outside incentive to innovate. The FDA is realizing the importance of modernizing the drug review process. A recent statement by Gottlieb emphasizes the importance of more widespread use of modeling and simulation, real world evidence, and the adoption of better tools in general. However, this is more difficult than it sounds. What’s the incentive model for getting groups together to decide on a standard process? The FDA is hoping to address this by publishing guidelines on innovative trial designs and then inviting companies into a pilot program. Still, the entire process will need to be very iterative to succeed.
- Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office
You don’t know what you don’t know. Until you actually run a thorough and innovative clinical trial, you really have no idea what the data will tell you. As an example, at Litmus, we’ve done a GI study with Takeda and have experienced the gamut of responses. We have confirmed our suspicions, disconfirmed our suspicions, and discovered things we didn’t know all at the same time. This goes to show that when you deploy advanced analytics, which suddenly enables you to draw correlations in the data that you wouldn’t have found before, the results can be surprising.
Keep your eyes on TriNetX. Kyle was especially excited about TriNetX, a global health research network that helps clinicians optimize their research and trials. Essentially, the company allows users to scan EMRs to find patients that are eligible for studies. This could be revolutionary. Imagine being able to enter in study criteria and out of 53 million patients, find how many patients are eligible and where they’re physically located. Of course, to ensure patient safety, everything is de-identified. However, the service could open up a pipeline for patients to clinical trials.
Trial by Data, presented by Litmus Health, is a podcast exploring the data-driven technologies and strategies shaping the future of clinical trials. We cover the most pressing issues and questions facing researchers and clinicians today, in an ever-changing landscape. Listen in as we interview leaders and innovators in the field who are at the forefront of developing and using these data-driven approaches.