Lab Samples: Like Clinical Research Gold
Lab samples may not be the first thing that comes to mind when thinking about clinical research, but their value should not be underestimated. The truth is that labs play a crucial role in measuring both safety and efficacy during a research study. To learn more about the role of lab samples in clinical research, we interviewed Wendy Komocsar, a Lilly clinical research scientist with first-hand experience as a lab technologist in the immunology field. Read on to learn why blood, urine and tissue samples are so important.
What role have you played in the lab and how does it shape your work at Lilly?
I started out my lab career focused at a large medical center at the bench as a worker bee and then as a manager of laboratories focused on diagnosing immune diseases. During this time period, the discovery of the HIV virus advanced the lab immunology field in understanding the virus, how it spread and developing great new lab based technology to help monitor the effects of the virus in patients. It was through this work that I developed a love for learning about immune diseases, which led me to immunotoxicology research in the preclinical space at two pharmaceutical companies. After spending 10 years in preclinical research, I wanted to get closer to the patient, so I transitioned to immunology research on the clinical side. As a clinical research scientist at Lilly today, I am responsible for developing research protocols. I use my lab technologist experience every day in activities such as determining study endpoints and interpreting safety data.
What is the interplay between safety and efficacy in the lab during a clinical trial?
The early testing of a potential new drug focuses on safety. Testing lab values is one method we use to measure whether a study medication is safe. Blood work, for example, can show us if the study medication is having unintended adverse effects on the liver, kidneys or normal functioning of the immune system. Once we determine that a study medication is safe to use, we design new trials to learn how the drug works and get more data on patient safety. At that point, the lab tests may also be used for measuring how effective the study medication is in the disease being studied. Take Crohn's disease as an example: A biopsy of the colon can indicate whether the study medication is promoting mucosal healing, a key indicator of an effective treatment.
Sometimes, getting a tissue sample or biopsy can be difficult or painful, so we are interested in using biomarkers wherever possible as a surrogate measure of the effects of the study medication. In newer areas of research, it may not be clear what those biomarkers are, or whether the biomarkers perform consistently over time. Therefore, a clinical trial may be designed not only to test the study medication but also to find or characterize a biomarker. In ulcerative colitis studies, measures of the protein calprotectin in a stool sample may serve as a good indicator of the disease activity in some patients, without having to take a biopsy of the colon.
Looking at more modern clinical trial applications, what are the benefits and challenges of collecting lab samples at home versus the research site?
When looking at ways to reduce the logistical burden of clinical trial participation, incorporating in-home lab samples is huge. For instance, in some cases traveling nurses can come to participants' homes to collect blood samples rather than requiring them to drive to the clinic. It's also common practice for people participating in a clinical trial for Crohn's or ulcerative colitis to collect stool samples at home. However, this type of collection can raise challenges around making sure that the lab sample is stored or shipped properly. When it comes to lab samples, the worst case scenario is to see a specimen go to waste because it wasn't preserved properly or was lost in transit.
If you were advising someone considering clinical trial participation, what would you tell them?
First, I would say, "thank you!" Joining a clinical trial is a selfless act that not only could benefit the participant, but future patients as well. As a clinical research scientist, I recognize the burdens that often come along with clinical trial participation, especially around lab tests. That said, it's important to understand that we consider each sample as a critical element of research and use them in every way we can think of—and even those that we can't quite yet. That's why we often freeze samples for use when a research field identifies a new type of test for a disease state. For me, lab samples are like gold!
Want to learn more about the role of the lab? Check out our Lab Samples and Clinical Research 101 blog.