29 May, 2019

Are there any disadvantages of using genetics in clinical trials?

From added costs to unintentional findings - there's a lot more variables to take into consideration when you use genetic testing in clinical trials.

Genetics are playing a key role in many clinical trials all over the world and predominantly in cancer treatments, where 73% of oncology trails use biomarker and genetic data. However, genetics are still not taken into account in half of clinical trials. In this article, we will explore some of the reasons not to use genetic data for a clinical trial.

In short here are the reasons not to use genomic data in a clinical trial:

  • Added cost
  • Your team may lack expertise
  • There may be unexpected findings for participants
  • You have straightforward recruitment requirements
  • There is no (known) genetic component to the condition
  • There are issues convincing decision-makers to adopt a new technology

Cost considerations

Firstly, genetic testing is expensive; the price can range from $100 to more than $2,000 depending on the complexity of the test.Although using biomarkers for clinical trial recruitment can often result in more efficient use of healthcare resources, including identifying the most effective treatments for marker-defined patient subgroups. The upfront costs involved with sequencing the entire patient population can be a significant additional expense.

However, as sequencing prices are projected to continue to fall, it is likely that using genetic data will become increasingly cost-effective. Furthermore, there may be opportunities to re-purpose existing data, by recruiting participants who have already been genome sequenced to save costs, and ensure that genetic factors are not biasing trial results. Continued advances will lead to huge savings on both the time and costs associated with conducting a clinical trial. These may include; reducing trial time and increasing speed to market and reducing your costs of recruitment in the long run.

Lack of in-house expertise

It’s worth noting that this is just the beginning of genomic medicine. We have only had the technology and information to be able to start genetic testing circa 1950. Although using biomarkers for clinical trial recruitment can often result in more efficient use of healthcare resources, including identifying the most effective treatments for marker-defined patient subgroups. The upfront costs involved with sequencing the entire patient population can be a significant additional expense.

Since then, genetic testing has only been used in a fraction of clinical trials, mainly within cancer research and by pioneering researchers, as specialist expertise is required to lead new genomics-driven trials and processes for testing new treatments. Due to the skills shortage in bioinformatics and data analytics, teams may lack the necessary in-house expertise, making it more difficult (and expensive) to undertake large scale genetic sequencing, counselling and analysis.

To complement your in-house capabilities, there are a variety of companies who offer genetic databases, counselling and analysis services to support cutting edge clinical research. These include; US biotechnology companies Veritas and Dante Labs and UK genetics specialists Sano Genetics.

Uncovering unintentional findings

When genetic testing is used in clinical trials, it opens the possibility of researchers discovering alleles in a participant’s genome which may be linked with other conditions. This can introduce challenging ethical questions about data handling, confidentiality, whether or not the patient should be informed and whether said individuals should still participate in the trial.

Additionally, these questions emphasise the need to have comprehensive resources and support programmes in place, to help participants understand the new information and genetic research being undertaken on their genomic data. There are a variety of companies that offer genetic counselling support alongside clinical trials, for example: WCG clinical services and informedDNA.

Simple recruitment criteria

If the trial does not require a highly specified group of research participants then using biomarkers to help filter people during your recruitment process may not be necessary.

However, in most cases, using biomarkers to identify the correct individual for participating in a study can significantly help to reduce screen failure rates.As it is reported that inclusion/exclusion criteria accounts for the majority of screen failures, it may be worth considering whether you can increase your chances of success through the use of biomarkers.

No genetic component

Some conditions do not have a genetic component and some treatments may not be influenced by the patients DNA. In these cases, it is often difficult to justify the need to use genomic data when recruiting/ screening for a clinical trial. Conditions which do not have a genetic dependency can include infection or parasitic diseases. However, the safety and efficacy of many drugs is affected by genetic variation in the enzymes that break down small molecules and biologics, even if the condition itself is not genetic.

Difficulty convincing others of the value

Although it may not be required in every trial, many trials would likely benefit from exploring the potential of genomics, but there is not sufficient buy-in from the organisation to make it happen, for one or more of the reasons detailed above.However, further genomics training, resources and data policies are needed to educate decision-makers on the possibilities of using genomic data.

If after considering why not to use genetic biomarkers for recruitment, you believe the use of genomic data might benefit your study, you can read our other post to find out the reasons to use genomics in clinical trials.

Also, if you would like to receive personal advice relating to using genomic data in your specific study, we’d be happy to help.

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