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The disadvantages to integrating genomics into clinical trials

Last week, we wrote a blog post on the benefits of integrating genomics into clinical trials, such as improved methods for patient stratification, contributing to genetic research and accounting for sources of variability.

However, genomics is not routinely integrated into around half of clinical trials. This blog post by Sano Genetics identifies reasons why people may not integrate genomics into their trials, a summary of which can be found here:

  1. Additional cost
    Although the cost of genetic testing is falling, it remains expensive depending on the complexity of the test. Using biomarkers to stratify patients may result in a more efficient trial, the upfront cost of sequencing patient populations can be a significant expense. As the cost of sequencing continues to fall however, it is likely that the process of integrating genetic testing can become much more affordable for clinical trials.
    Likewise, as genetic sequencing becomes more widespread, it may be possible to re-purpose existing data by recruiting participants who have already had their genome sequenced.
  2. Team expertise
    The integration of genomics requires a lot of specific expertise from data analytics, bioinformatics, and counsellors. A given team may lack specific expertise that is necessary for genetic integration, making it more difficult and expensive to undertake.
    While there are companies that offer counselling and analytics services, it is a consideration for any trial organiser to consider.
  3. Recruitment criteria
    If the trial does not require a highly specific group of participants, then using genetic information to recruit may be unnecessary. However, still in most cases using biomarkers for recruitment has reduced failure rates.
  4. Genetic components
    Some conditions do not have a genetic component (such as infectious diseases), or treatment options may not be influenced by the patient’s genetics. In these cases, it can be difficult to justify the use of genomic data in the clinical trial because of the additional costs. While there are still options for using genomic data for the safety or efficacy of drugs for diseases that are not genetic, it may not always be justified.
  5. Unintentional findings
    When you integrate genomics into trials, it may be possible that researchers find alleles in the participant’s genome that are linked to other, detrimental conditions. This presents challenges about data handling, confidentiality and whether the patient should be informed. The questions also emphasise the need for a larger range of resources and support programmes to help participants understand any new information found about them.

While most trials would arguably benefit from exploring the potential of genomics, not all organisations will support the integration because of one or more of the above considerations. Further training and increasing the understanding of the potential of genomics, both from a patient perspective and for cost-benefit, will help decision-makers decide when to invest in implementing genomics into their trials.


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Clinical Trials / Genetics / Genomics / Sequencing