The future of clinical trials

The process for clinical trials is ripe for disruption

Looking at the current “clinical gold standard” for clinical studies, you will inevitably come across randomized controlled trials (RCT). In this approach randomized controlled treatment groups are used. A randomly selected treatment group receives either the drug or a placebo.

This process is a capital-intense and time-consuming one. Studies estimate that the clinical trial process lasts 9 years and costs $1.3B on average! The cost of failure is enormous. Clinical trials can fail for many reasons: failure to recruit sufficient participants, mid-trial patient drop out, side effects or inconsistent data.

The journey of a patient participating in a clinical trial is not a pleasant experience at all: patients need to find a suitable study and pass medical examination, enroll for the study and maintain a mostly handwritten diary as a form of adherence monitoring. Once a month or so they need to show up for follow-up visits where the trial researchers then rely solely on the patient’s memory and diary entries.

Moving towards virtual clinical trials

There are plenty of reasons why virtual clinical trials (also called in silico trials) are seeing a rapid growth in adoption. Pharma companies have enough incentives to seek for innovative ways to facilitate trials to save the average cost of $41.000 per patient per trial (!) and are obviously willing to pay for good solutions that can reduce costs.

In silico trials are using computational models to simulate how a drug, medical device, or intervention will affect a virtual population. Researchers can use modeling and simulation to predict outcomes before advancing to in vivo trials and ultimately design studies that are just more likely to succeed.

There are several companies on the market that recognized the opportunity already. XO Life, formerly known as Medikura, offers patients a platform to digitally monitor their experiences and reactions to medications and then models possible side-effects patients can expect from certain drugs while in the meantime communicating valuable data with pharma companies.

How real-world-evidence works

XO-Life is a great example of the power of Big Data: by providing an innovative communication platform through which high-quality real-world data on the effects and side effects of drug therapies gets collected. The primary goal is to standardize the data sets and make them available in real-time to all affected individuals as well as medical professionals and research companies.

Data per sé is worth nothing – only processed and analyzed data makes a valid and lucrative business model. There is still a gap in the healthcare market in regard to providing validated real-world-evidence-based data sets and we believe that 2022 will be another year of big advancements in this area.

XO-Life is building the digital future of health

We closed our investment campaign with XO-Life at the end of 2022 and helped the start-up to close its €2M funding round. The money will primarily go towards expanding the product and development capabilities of the platform.

Patient insights are a perfect way to close the gap between fully virtual clinical trials and traditional real-world trials or to make the latter far cheaper than they currently are. Pharma has been a capital intense and slow-moving industry. With advancing technology, we are slowly seeing the industry change.

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