I had the pleasure of speaking with Kelli Aufderheide, a leader in laboratory decentralized trial solutions, about microsampling in clinical trials, and the advancements that are supporting the wave of new devices and applications in patient-centric sampling.
Steve: Tell us a little about your role and your interest in microsampling techniques and applications?
Kelli: Absolutely, I have been in the clinical trials industry for nearly 20 years and have a passion for enabling access to clinical trials so patients can get the care they need. I currently serve as the Director of the Decentralized Trials team at IQVIA Laboratories. In my role, I support my team on advancing all decentralized aspects of clinical trials, from remote patient collections to microsampling and self-collection, even deploying point of care testing (POCT) devices to sites and patients, we focus on the various patient centric sampling options.
Steve: Currently, what are you seeing across laboratories pertaining to microsampling?
Kelli: The use of microsampling in clinical trials has been on the rise in recent years, partially thanks to easy-to-use devices enabling this technology, but also from the Covid-19 pandemic accelerating the acceptance of non-traditional sampling techniques.
As you highlighted in a previous blog article, there are over 40 commercially available technologies for collecting micro samples. From cards and swabs that collect dried blood spots (DBS), to finger stick mechanisms that assist in fingertip capillary collections, even upper arm devices that can collect full size tubes of blood.
Sponsors are very interested in reducing the amount of blood necessary for testing while ensuring patients are having the best clinical trial experience possible. However, there are still some obstacles that need to be overcome before microsampling is as mainstream as venipuncture sampling.
Steve: Let’s talk more about those obstacles. Can you speak to what we encounter regarding the challenges?
Kelli: From my perspective, there are several challenges we still face in deploying microsample options in clinical trials, as a start, if microsample use is desired, the timing of correlation studies can be challenging. The earlier this can be decided in a drug lifecycle the easier it will be to incorporate into trial designs. To maximize the use of microsampling across all the clinical trial phases, the correlation studies should be started early in the drug phase and completed with the proper device selection. Additionally, there are still regulatory restrictions on capillary sample types, many of these assays require a full validation, including correlation studies, to be used widely in clinical trials.
Steve: What other factors go into the decision on microsample use?
Kelli: Key decisions our team of experts often discuss with our sponsors are:
- Do you need a wet sample, or will dried blood suffice?
- Does the capillary-blood device sample correlate to the venous-blood (or plasma/serum) results previously validated?
- Are the devices you are interested in available in all regions where you will need it?
- Do you need to try multiple devices to see if one provides better correlation?
The answers to these questions are critical to ensuring the best microsample option is selected for the trial, the patient population, and optimal results.
Steve: In assessing the microsampling options, how much re-validation of the analytical method do you find is necessary?
Kelli: Once the device is determined, we are typically engaging our laboratories for bridging studies and assessments for feasibility with the targeted patient populations. The extent of the bridging study will depend on the use of the results downstream. A full validation may be required to enable data inclusion in regulatory submissions. The regulatory experts would be the best consult to ensure the results obtained will be valid for submissions. The critical component to inclusion is preplanning. For example, our experts can be engaged to evaluate bridging study plans or protocol design to ensure the appropriate sample type, visit structure, and application for including microsample collections.
Steve: Are there other aspects that you find the teams needing to navigate with microsampling?
Kelli: IQVIA Laboratories has successfully deployed several devices on clinical trials, enabling dried blood spot and microsampling for PK collections and biomarkers. The remaining hurdles to overcome for widespread use include sample collection, processing, and shipping logistics. Some analytes, even safety testing, are stable enough for immediate, ambient, shipping, and delayed processing at the lab. Whereas other analytes require immediate processing prior to shipping. Ensuring sites can process microsamples will help to advance these critical collections in clinical trials.
The advancement and acceptance of microsampling has also begun to open the door to enable patient collected samples. Patient collected samples add another layer of complexity and present their own set of challenges, however, continuing the path forward for microsampling will help reduce these challenges.
Steve: It’s apparent that microsampling in the context of patient-centric sampling is enjoying a surge of popularity right now, what are your own thoughts of the future of this exciting area?
Kelli: The microsampling work we are doing within the Decentralized Clinical Trials (DCT) team and our laboratory, excites me for the future possibilities with microsampling and the self-collection it will enable. We are partnering with device companies and sponsors to continue to advance microsampling. Focusing on patient experience, reducing the amount of blood necessary for testing, and allowing better trial access for patients are all goals of decentralized trials.
While the patient focus is the primary driver, microsample testing also has a benefit for sponsors including better retention, potential for per visit cost savings, and enabling more frequent sampling, which provides more data for critical drug development decisions.
With early engagement of the laboratory science experts, sponsors can utilize the testing sooner, enabling more frequent collections and data points for better insights on their trials. The future of clinical trials is being enhanced with the increased use of microsampling and the addition of self-collection.
Note from Steve: I’d like to thank Kelli for her insightful contribution on this important topic. I join many in saying that we greatly value her passion and the valuable work she does for advancing decentralized clinical trials, and most importantly, helping patients receive the care they need.
