A late-stage biopharmaceutical company dedicated to metabolic and chronic liver diseases is developing an in vitro diagnostic (IVD) test for NASH at-risk patients. The test integrates four independent biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c. The output is a 0-10 score with threshold values, identifying patients with low risk or high risk of developing NASH.

The main objective of this study is to evaluate the physiological stability of these biomarkers between the fed and fasting state in patients with the target condition (NAFLD) over a 30-day period.

Discover how our team of experts helped this biopharmaceutical company to reach its goals

Connecting real-world laboratory data from clinical sites and digitalizing patient data – the power of Decentralized Clinical Trials (DCT) to change the trials of tomorrow

Digitalization continues to provide an impetus to move away from centralized, high-cost and difficult-to-access settings to more virtual, patient-centric and decentralized clinical trial (DCT) models. Our methods need to be more patient-centric, and we need to collaborate to find remote solutions.

Thanks to digitization, we can now decentralize clinical trials and put patient data in front of research success. In partnership with Biokortex, Cerba research will show participants of this webinar a picture of the future: how clinical trials will look tomorrow. New technologies allow us to imagine a whole new process for drug development and assays. This new way of thinking reduces costs and enhances access to data. The world is evolving fast, and we need to develop accordingly. Agility, adaptability and digitization need to be the new keywords for a more manageable and secure development.

Watch the recording of this webinar to learn more about patient recruitment for decentralized clinical trials.

Cerba Research is the Belgian division of the French Group Cerba Healthcare. The company facilitates clinical studies and lab tests, and supports the entire logistics chain. What are the developments in this market and what does the future bring?

Cerba Research may not be known to the general public, but the company does have reputable pharmaceutical companies as customers. Why do they join forces with Cerba Research, and which added value can the organization in Ghent offer? Pharmaceutical companies may have testing capabilities, but the entire logistics process that surrounds it is our specialty. For example, how can you distribute sample kits quickly, efficiently and without issues? That’s what we are perfectly suited to do. We gather all the materials needed to collect samples and deliver them neatly in kits. We also process and prepare all the patient data paperwork. Once all the data has been received, we order lab tests, in our own labs or through partners. The results are then made available to the client via PDF’s and our electronic portal.

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A staggering number of clinical trials fail to enroll enough patients. Most of the time, it’s not because the patients don’t exist; it’s finding them that can be difficult.

This is a struggle that Professor Karine Lacombe’s team at the infectious and tropical diseases department of Saint-Antoine Hospital in Paris know all too well. In addition to overseeing the department’s clinical research activities, she is also an investigator and co-investigator of several national and international cohort studies and multi-center trials in the field of HIV-viral hepatitis coinfection and Covid-19, and is a scientific manager of interventional studies in public health.

Professor Lacombe spoke to Clinical Trials Arena about the difficulties of patient recruitment and a new application the department is using to boost patient numbers. She starts by outlining her team’s previous approach to recruitment, which involved total reliance on the department’s own digital database of inpatient records.

“To find patients for a trial, we go into the database and use the inclusion criteria to ask if we have patients that respond to the eligibility criteria,” Professor Lacombe explains. “The problem with this approach is that we can only act on patients who are followed for chronic infection, whereas some of the trials we have recently started require patients who are in an ambulatory setting.”

For help finding outpatients, the hospital started contacting colleagues in the wider community who could search databases of their own. Often, however, these individuals didn’t have time to assist.

“It has been very difficult to identify the required patients,” says Professor Lacombe. “This approach has not only delayed inclusions; in some trials we have not even been able to include patients, especially for Covid-19 trials that addressed ambulatory care or prevention. That’s why we had to change.”

Download the full article to discover how Cerba Research has helped Saint-Antoine Hospital boost patient recruitment with medical laboratory data

The new big data application is reshaping clinical trials. Someone on the shopfloor spots an improvement or better way of doing things that snowballs into a business; it’s a familiar approach to innovation and entrepreneurship. Indeed, many big technology firms deliberately encourage this behaviour.

But it’s less common for a practising doctor to create a successful technology solution. But let that be the story of Adrien Ko, who hit the idea for his data-driven patient recruitment start-up while he was supervising a lab for Cerba Healthcare in France.

Patient recruitment has always been a challenge for clinical research, with most clinical trials failing to enrol enough participants in time, let alone the right patients. When trying to get a study initiated, enrolment challenges are more than just inconvenient; they can also be incredibly costly. With close to 100% of studies requiring timeline extensions for recruitment, it’s no surprise the global clinical trials industry spends more than $2 billion on enrolment efforts and delays each year.

Find out how Cerba Research is leveraging the biological and clinical data from patients visiting its parent company’s network of clinics.