The forefront of personalized medicine is dramatically reshaped by advancements in biomarker discovery and digital health technologies (DHTs) – and the topic was discussed at the 2024 SCOPE Summit. Spearheaded by pioneers like Dr. Michael Snyder, Chair, Dept. of Genetics and Director, Center for Genomics and Personalized Medicine at Stanford University, these innovations offer a glimpse into a future where healthcare and clinical trials and medicine are tailored to the individual, not just the population. Dr. Snyder’s research emphasizes the importance of understanding each person’s unique biological blueprint, highlighting the potential to improve early detection, intervention, and the efficacy of treatments through a more nuanced grasp of personalized health markers.
Personalized Biomarkers
Snyder began by debunking the myth that the average human temperature is 98.6°F, presenting a Stanford study that identified the true average as 97.7°F, with a notable spread between individuals. This variation highlights the danger of relying on population averages in health assessments. Further emphasizing the importance of personalized baselines, Dr. Snyder discussed the discovery of distinct ‘aging types’ in individuals, a concept derived from deep longitudinal data collection. This research has identified patterns in how different biomarkers change over time, suggesting that each individual ages uniquely. For example, one person’s typographic signaling pathway could be cardiac signaling, indicating a predisposition to cardiovascular issues, while another might be immune system-related.
These insights from their ‘omic’ data can be directly applied to clinical trials to create more customized interventions, potentially improving outcomes by monitoring for early signs of age-related diseases. Such personalized metrics could transform clinical trials’ monitoring, detection, and evaluation of participants. Dr. Snyder’s work illustrates that with a more nuanced understanding of an individual’s baseline, clinical trials could shift from a reactive approach—where treatments are administered after disease onset—to a proactive one emphasizing prevention and early intervention.
The Omics Approach to Clinical Trials
By profiling over 100 individuals for nearly a decade, Dr. Snyder’s team has amassed a wealth of health data—spanning genomics, proteomics, and metabolomics. Within the first 3.5 years, this meticulous study led to 49 major health discoveries, all identified before any symptoms presented themselves.
This preemptive identification of health risks is particularly transformative for clinical trials. It suggests that trials can be designed to test therapeutic efficacy and incorporate preventive strategies. Biomarkers discovered through omics profiling can serve as early warning signals, enabling researchers to intervene before a full-blown disease manifests. For instance, by identifying a biomarker that indicates a pre-disease state in cardiovascular health, a clinical trial can be tailored to monitor patients more closely for heart-related outcomes, adjust treatments preemptively, and measure the efficacy of interventions aimed at halting or reversing the progression towards the disease. Additionally, novel therapeutics can be developed, or existing therapeutics can be administered to treat the underlying causes of age-related diseases rather than treating the disease itself.
DHTs for Future Monitoring
Dr. Snyder’s exploration into the use of DHTs for health monitoring provides a vivid glimpse into the future of proactive healthcare and clinical trials, as he provided a personal example regarding the early detection of Lyme disease using DHTs. He recounted how his smartwatch and pulse oximeter picked up unusual changes in his physiological data—specifically, a significant drop in blood oxygen levels and an unexpected increase in heart rate while on an airplane that remained well after he landed. These changes were the first indicators that something was amiss, even before he experienced any traditional symptoms of Lyme disease. Upon noticing these anomalies, he was able to seek timely medical attention, leading to an early diagnosis and treatment for Lyme disease. This example highlights the potential of DHTs to act as an early warning system for health issues, highlighting their value in both personal health monitoring and the broader context of clinical trials.
The application of DHTs in clinical trials represents a transformative shift towards real-time, continuous monitoring of participants. This methodology extends beyond traditional episodic data collection, allowing for the capture of subtle physiological changes that might precede symptomatic expressions of a condition. In a clinical trial setting, DHTs can provide a wealth of data points, from heart rate variability to sleep patterns, that can be analyzed to gauge participant responses to treatments or interventions. Moreover, these devices can detect adverse reactions early in the trial process, facilitating quicker medical care and improving protocol adjustments or therapeutic dosages. The end result is a more dynamic, responsive, and ultimately safer trial environment for participants, promising to improve trial outcomes and accelerate the path to treatment discovery.
Microsampling: A New Frontier for Labwork in Clinical Trials
Dr. Snyder’s introduction of the home microsampling technique marks a significant advancement in how biological data can be collected for clinical research. By enabling researchers to obtain a comprehensive view of a participant’s health status via analyzing thousands of analytes, this method allows participants to collect blood samples in the comfort of their homes and send them for analysis, drastically simplifying the data collection process in clinical trials and reducing patient burden.
In one of Dr. Snyder’s microsampling studies, participants used this technique to provide samples that were then analyzed for a broad range of health indicators. One significant discovery made through this approach was the early detection of diseases like early lymphoma and precancerous conditions, which were identified before any symptoms were noticeable to the patients. This presymptomatic detection capability exemplifies home microsampling’s profound impact on clinical trials, enabling earlier interventions, personalized treatment adjustments, and potentially improving outcomes by addressing conditions before they progress.
Moreover, the ease and convenience of home microsampling easily integrates into decentralized clinical trials (DCT), leading to higher participant engagement and retention rates and opening up trials to a broader demographic, including those living far from clinical centers or having mobility issues.
Body Metabolism: The Next Generation of Therapeutic Personalization
Dr. Snyder’s investigation into metabolic responses to food intake illuminates the intricacies of individual health and the potential for personalized medicine. His research has shown that people’s bodies react remarkably differently to the same foods, highlighting human metabolism’s complexity and personalized nature. In his presentation, Dr. Snyder provided compelling examples to emphasize this point. He mentioned how, through continuous glucose monitoring, his team observed diverse reactions to common foods like bananas and cookies among study participants. Remarkably, one person’s glucose levels spiked significantly after eating a banana but not after consuming a cookie, while another participant experienced the opposite reaction.
Moreover, Dr. Snyder discussed the broader implications of these findings for metabolic-related diseases, such as diabetes and metabolic syndrome. By identifying “glucotypes” or patterns in how individuals’ blood sugar levels respond to specific foods, researchers can better understand the risk factors for these conditions and develop more personalized medicine and management plans.
This discovery is pivotal for clinical trials, as it suggests that understanding and accounting for each participant’s unique metabolic response can lead to more accurately tailored interventions, thereby improving therapeutic strategies’ toxicity, efficacy, and safety. Additionally, this approach offers a glimpse of how clinical trials can be designed to test interventions customized to individual participants’ metabolic profiles, thereby enhancing therapeutic precision and patient care.
Summary
Dr. Snyder’s research marks a momentous shift towards more personalized medicine and an effective approach to medicine and clinical trials. Through the lens of biomarker discovery, omics profiling, DHTs, and an intricate understanding of individual metabolic responses, his work lays the groundwork for a future where medicine is as unique as the individuals it aims to treat. As these technologies and methodologies evolve, they promise to transform clinical trials and redefine our approach to disease prevention, diagnosis, and treatment, ushering in a new era of personalized medicine.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
