Heterogeneity and precision medicine: An integrated approach
Precision medicine promises a future where treatments are customized to the unique characteristics of the patient and their disease. At the heart of many projects is the search for genetic markers that can be used to predict, diagnose and track diseases and treatments, but genetics is only one small piece of the precision medicine puzzle.
Too often, researchers only track those things that are easily measured in a lab, such as the presence or absence of biomarkers. But there can be a host of clinical, social, behavioral and environmental factors that could further define the phenotype of a disease and the outcome of treatment in different patients. These factors are often more difficult to quantify and measure, but if researchers want to understand the full clinical heterogeneity of their study participants, they need to take them into account.
Making integrated data collection a key component of the research lifecycle allows for a more comprehensive view of the patient’s condition, treatment experience and outcomes. These enriched studies can include data from secondary research, electronic health records (EHR), patient registries and patient and physician reported outcomes. The challenge, however, is determining how to best harness these data sets in support of ongoing research and how to address key issues that stand in the way, including the limited interoperability of data systems and the need for better tools to validate data quality and protect the privacy and security of the information being analyzed.
In many cases it takes significant time and effort up front, and ideally requires researchers to engage directly with patients through registries, focus groups and panel discussions, but the effort is worth it. The insights garnered through these efforts increase the ability of researchers to align treatments with the right patient populations, which improves the likelihood that a drug or therapy will have the intended outcome—one which benefits everyone.
Written by Guest Writer Jennifer Christian. Christian is Vice President of Clinical Evidence within the Real-World & Late Phase Research Scientific Affairs group at Quintiles, where she provides scientific oversight to the design and conduct of real-world studies, including minimally interventional, clinical effectiveness and safety evaluations. Dr. Christian has conducted numerous studies using large claims databases, electronic medical records and prospective clinical studies. More recently, she has focused on pragmatic and hybrid study design approaches for enhancing safety and effectiveness evaluations.
This article was reprinted from Volume 23, Issue 10, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact firstname.lastname@example.org. Subscribe >>