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Clinical trials enter the genomic age

Looking at the factors driving this change and assessing the benefits
Clinical trials enter the genomic age

The advent of ground-breaking genomic technologies in the clinical environment, such as Next Generation DNA Sequencing (NGS), bioinformatics and artificial intelligence, has ushered in a new era in healthcare. Every day, a gigantic amount of genomic information is generated and analysed to identify pathogenic mutations in patient DNA. This new paradigm, known as 'Data-Driven Medicine', already allows clinicians to treat the causes of disease rather than its consequences and opens up new treatment opportunities for patients. This has been exemplified in cancer care where therapeutic decisions do not solely rely on morphology, but also on a patient's unique molecular profile.

However, the production and analysis of patient genomic profiles is only the first part of the Data-Driven Medicine story. The second step is to leverage this deluge of information. When used wisely, the insights gleamed can bring order and efficiency to clinical trials. For patients, tailored care options that respond to their unique genetic make-up can be quickly and accurately assessed.

It's no secret that clinical trials are the costliest step in bringing a drug to market. Statistics show that the whole endeavour is slow and inefficient. Many cancer treatments are only beneficial for the small number of patients who receive them, resulting in great pressure on national healthcare budgets and passionate debates about drug pricing.

The main barrier for clinical trials remains the enrolment of patients. It is estimated that more than 80% of cancer trials fail to reach their recruitment goals. This issue is compounded when the drug being studied for a particular trial is only beneficial for a small subpopulation of patients. The situation for rare diseases is even more acute. This recruitment step adds to the already long time frames pharmaceutical companies face in bringing new drugs to patients.

Recent advances in genomic technologies have the potential to dramatically expedite clinical trials. By looking at genomic profiles, patients can quickly be matched to the most promising clinical trials. In fact, with thousands of patients benefiting from genomic diagnosis every month for conditions such as oncology, hereditary cancer, cardiology, metabolism and paediatrics, pharmaceutical and biotechnology companies now have a chance to tap this information to ensure patients with the right genomic profiles are matched with the right clinical trials.

It is estimated that more than 80% of cancer trials fail to reach their recruitment goals

This means the clinicians' role does not stop with consultation but extends to referring patients to clinical studies according to their genomic profile. Such studies are usually designed to target a particular molecular abnormality, for instance, in the case of new cancer drugs, the molecular profile of a particular tumour. This information also empowers patients. It means timely access to medication, benefiting from and participating in scientific advancement and receiving care through clinical trials.

Accordingly, pharmaceutical companies need to start looking for genomics partners that are capable of bringing speed and efficiency to their clinical trials. In doing so, the key elements to take into account must be the number of patients' genomic profiles analysed by genomic platforms, their geographical footprint and their existing level of connectivity with hospitals and laboratories, ie the number of healthcare institutions that already use them to diagnose patients every day. The higher the number of hospitals and labs using the platform to diagnose patients, the higher the chances to identify relevant patients and offer them the opportunity to participate in a targeted study that could eventually offer them the exact therapy they need. The critical mass of this community is key to ensure subpopulation analysis can be performed to improve drug development.

And the same factors are particularly important when it comes to companion diagnostics products. The same genomic platform helping to stratify patients for clinical trials can also be leveraged by clinicians to identify the patients that can benefit from the therapy, and ensure its safe and effective use. The increasing use of molecular drugs targeting specific genomic profiles goes hand-in-hand with the co-development of companion diagnostics in the drug development process.

As we have seen, the identification of patients' genomic mutations presents an opportunity not only to diagnose patients more easily, efficiently and quickly, but also to refer patients to clinical trials, identify which drugs are efficient for which genomic profiles, and finally ensure that the patients benefit from tailored treatments. Lower cost and more accurate high-speed methods for sequencing and analysing patients' genomic profiles have given the industry faster and more efficient ways of conducting late-stage patient trials. It is now high time pharmaceutical companies leverage the largest genomic platforms to improve the efficiency, costs and success rates of new drugs in clinical development, and ultimately expedite the time for providing new treatment options for the patients who are most likely to benefit.

Article by
Jurgi Camblong

CEO and co-founder of Sophia Genetics

18th October 2016

From: Research

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