There is huge potential for genomics to improve effectiveness and lower costs in healthcare. The reduction in sequencing costs and the availability of tools to securely store, process, and analyse large-scale data is accelerating research in genomics, and fueling progress. One area within this field with the fastest growth and greatest potential is the incorporation of genetic testing into clinical trials.
The implementation of genomics-based studies has been strongly encouraged by the FDA. The FDA guidance for E18 Genomic Sampling and Management of Genomic Data 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."
While still early days, research demonstrates that clinical programmes and trials may benefit from incorporating genetic testing initiatives into their studies. Here, we explore the enormous potential of genomics-based clinical trials, drawing upon a variety of publications to better understand how genomics can improve trial success and accelerate the pace of clinical research.
A major reason that clinical trials are incorporating genomics is to account for variability in treatment effects. Analysing the genetic differences in participants can drive the identification of biomarkers associated with the clinical outcomes of patients. Biomarkers play a critical role in drug development and the FDA states, “the identification of genomic biomarkers underlying variability in drug response may be valuable to optimize patient therapy, design more efficient studies, and inform drug labelling."
By utilising genomics at the point of recruitment, these underlying genetic differences can be used to distinguish patients into subgroups. The stratification of patient groups may be useful to find the best candidates for your trial. Research by KPMG states:
“Using patients’ genetic profiles, R&D teams should be able to narrow down patient groups into subsets with a higher chance of responding to a specific treatment. This should speed up trials and eliminate ineffective therapies at an earlier stage, getting products into the market sooner, at a lower cost.“
In markets such as the UK, Europe, and the US, where rising healthcare costs are under great scrutiny, many healthcare payers are likely to demand stratification to ensure that costly treatments are delivering value.
While the implementation of genomics may advance our understanding of diseases and improve drug efficacy, in some studies, the patient identification process may become much longer, particularly in the case of rare diseases. Research on executing successful clinical trials by David B. Fogel highlights this challenge. Fogel states that “bringing eligibility to the level of the individual holds the promise for establishing greater study drug efficacy but also has the drawback of limiting the available sample size.
To find adequate numbers more quickly, clinical researchers can consider building partnerships with global genomic research platforms. Partnerships and collaborative initiatives can help researchers raise awareness, gain broader reach and increase the pool of potential participants to enable faster trials. For example, these techniques were implemented to drive patient engagement in Alzheimer’s disease research. The Alzheimer’s research undertaken by Fundació ACE states “to increase the pool of potential participants we considered the possibility of expansion of recruiting sites, coordination of participant registries, coordination with primary care and other local medical centres, and increasing awareness and improving the general public’s attitude towards participation in research through advertisement and outreach."
A critical part of genomics-based trials involves interpreting the results of genetic testing and providing ongoing support for the patient groups. Access to expert advice and guidance can be gained through collaboration with genetic counsellors, specialised physicians and genomics testing platforms that provide detailed and reliable patient insights. Telemedicine may also be beneficial to ensure support can be provided to patients regardless of their geographical location.
As this high-touch approach to patient support increases patient involvement and engagement in all aspects of the clinical trial, overall higher patient engagement could lead to increased efficiencies in the research process and interest in re-contact for future clinical trials, or pharmacovigilance.
Widespread adoption of genomics within clinical trials is necessary to generate the massive amounts of data, genetic information and repeatable outcomes needed to make personalised medicine a reality. This progression will help to advance the development of targeted therapies to a new level, where all individuals can gain better healthcare with personalized medicine. As KPMG’s research into driving value from genomics concludes, “Genomic data can take the sector into an era of highly personalized medicine, where patients get treatment tailored to their genetic make-up, with a greater chance of success, delivering value to the healthcare system."