How Pharmacogenomics Can Benefit Your Clinical Trial

Early Phase Clinical Trials, Clinical Research

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

6 Ways Pharmacogenomics Helps Your Clinical Trial

  1. Enhances Drug Safety
    PGx acts as a predictive tool, foreseeing potential drug toxicities and reducing the occurrence of adverse reactions. For example, Azathioprine, an autoimmune disease and organ transplantation treatment, was linked to severe myelosuppression for patients with specific genetic variants, such as the TPMT and NUDT15 genes.
  2. Optimizes Drug Efficacy
    When taking into consideration individuals’ genetic factors, drug developers can more accurately predict the drug efficacy for each participant and, eventually, more precise dosing. One gene, known as the CYP2C19 enzyme, can convert Clopidogrel, a blood thinner used to prevent stroke and heart attacks. However, certain variants may not metabolize this blood thinner as efficiently, rendering the treatment less effective in those participants.
  3. Guides Dose Optimization
    PGx allows for optimal dosing, ensuring that each participant receives the most effective and safe dose based on their genetic profile. For drugs with a narrow therapeutic index, such as Warfarin, an anticoagulant, dosing is especially important. If a participant is given too large a dose of Warfarin, it could lead to life-threatening bleeding, conveying the necessity of PGx testing.
  4. Reduces Trial Failures
    Oftentimes, clinical trials may fail due to a lack of efficacy. By screening subjects based on their genetic profiles, it reduces the likelihood of trial failures attributed to genetic variations in the study population. One breast cancer treatment, Tamoxifen, for example, relies on the CYP2D6 enzyme in order to be effective. Certain variants of CPY2D6 reduce enzyme activity, thereby reducing the benefit of Tamoxifen.
  5. Cuts Healthcare Costs
    With PGx testing and its personalized treatment strategies, your participants will have:
    – Shorter hospital stays
    – Fewer medical complications
    – Decreased need for further treatments
    As a result, your clinical program will have reduced overall healthcare expenses for its patients.
  6. Ensures Regulatory Compliance
    Another way your clinical trial will benefit from pharmacogenomics is through streamlined regulatory processes. Incorporating PGx in clinical trials accelerates the approval process by providing comprehensive data on drug responses, which can support New Drug Application (NDA) approvals.

Learning More About the Power of Pharmacogenomics

Over 200 genes have been discovered as pivotal in PGx testing, affecting processes such as the absorption, metabolism, distribution, and excretion of drugs. PGx is not only a scientific breakthrough but a promise for a future where medicine is safer, more effective, and tailored to individual genetic profiles. To learn more about these various genes and how they can affect your clinical trial participants, as well as to understand the full extent of the power of pharmacogenomics, check out our white paper.

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