Genomics has the potential to improve efficacy of drugs and accelerate precision healthcare, but one area with the biggest potential is the incorporation of genetic testing into clinical trials.
Implementing genomics into studies has been strongly recommended by the FDA. The guidance states:
“With advances in science and increased awareness of the impact of genomics, there is a need and an opportunity to maximize the value of the collected samples and the data generated from them. Therefore, genomic sample acquisition is strongly encouraged in all phases and studies of clinical development.”
In this blog post, Sano Genetics explore the potential for genomics-based clinical trials and how it can be used to improve trial success and accelerate the pace of clinical research, a summary of which can be found here:
- Account for sources of variability
One of the major reasons that clinical trials are incorporating genomics is to account for variability in drug response. The genetic differences in participants can enable scientists to identify biomarkers associated with the clinical patient outcome, which plays a key role in drug development.
According to the FDA, “the identification of genomic biomarkers underlying variability in drug response may be valuable to optimise patient therapy, design more efficient studies and inform drug labelling”.
- Patient Stratification
When recruiting patients on clinical trials, utilising genomics could help distinguish patients into subgroups. The stratification of patient groups can help to identify the best candidates for a trial which could speed up trials and eliminate ineffective therapies at an earlier stage. Eliminating ineffective therapies can enable teams to get products to the market sooner and reduce costs. Payers are likely to demand stratification in the future to ensure that treatments are delivering good value for money.
- Building global research platforms
While patient stratification can enable the trial to be more effective, for some trials, the patient identification process may become longer, like in the case of rare diseases. Clinical researchers can consider building research platforms where they can form partnerships and collaborative initiatives to help gain a broader reach and increase awareness of trials.
- Increased patient engagement
When integrating genomics into trials, result interpretation and ongoing support for the patient groups can increase patient engagement. This type of engagement has shown to increase patient involvement in the trial and lead to increased efficiencies and increases opportunities of contacting them for future trials or for pharmacovigilance.
- Contributing to the future of personalised research
As the adoption of genomics in clinical trials becomes more widespread, this can contribute to the future of personalised medicine research with data sharing.