The use of biomarkers in clinical trials can aid operational efficiencies in drug development that as of yet, haven’t been fully realized – arguably, it must be said. But how can biomarkers best be leveraged to reduce timelines and altogether bring drugs faster to market?

In this Industry Viewpoint, Irene Mayorga Ruiz of QUIBIM sits down with Henry Kerali to discuss the importance of biomarkers. An experienced professional, Ruiz is a biomedical engineer who specializes in obtaining imaging biomarkers from medical images with treatment response value. Here, she explains how biomarkers can be incorporated into clinical trials and be fully maximized.

Henry Kerali: What are some of the unique challenges posed by biomarker-driven studies, and are they part of an industry-wide problem?

Irene Mayorga Ruiz: One of the problems in the industry is the late detection of the effectiveness (or lack of) of the drug under study. The trial sponsor, as a result, can lose significant amounts of time and money before coming to this realization during a final study. Imaging biomarkers can reduce those times and the level of investment as they can detect subtle changes in tissue properties not noticeable to the naked human eye.

HK: How can imaging biomarkers help pharma companies conduct clinical trials?

IMR: The incorporation of imaging biomarkers in clinical trials favors the objectivity of radiological reading, easing and homogenizing radiological conclusions. This objectivity helps the comparison of the results between centers, thus facilitates the extraction of conclusions from the trial. To avoid discrepancies between radiological readings from the different sites, QUIBIM offers a centralized radiological and nuclear medicine reading.

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Facing this problem, QUIBIM has developed a cloud-based medical imaging platform (QUIBIM Precision®) that has integrated imaging biomarkers. Furthermore, it has relevant characteristics for real-time monitoring in clinical trials. QUIBIM Precision® has an imaging biomarker results miner, queries notification systems, quality assurance, and an audit trail module compliant with the FDA CRF 21 part 11 guidelines.

HK: How can the use of digital biomarkers create operational efficiencies in drug development?

IMR: Imaging biomarkers extract and measure objective biological characteristics from medical images of any radiology or nuclear medicine modality, providing information related to the biological situation and clinical problem.

Imaging biomarkers are very sensitive to small functional or morphological changes that cannot be reported in the radiological qualitative reading during the same time periods, since they are not visible to the human eye. Because of that sensitivity in a shorter time, the evolution of the different branches of treatment can be studied in real-time. This helps reduce time while facilitating the decision making within clinical trials.

HK: What are the keys to an effective clinical biomarker strategy?

IMR: The key point for an imaging biomarker strategy is the calibration of the scans used in the image acquisition. In this regard, QUIBIM’s strategy is to cross-calibrate using phantoms in all the scanners included in the clinical trial. The purpose of this calibration is to know the biases of each machine included in the trial. During imaging biomarker quantification, the biases detected in the calibration step are taken into account. This calibration ensures the reliability of biomarker results.

An additional key aspect is image quality, because of that a quality assurance check has to be done for each of the studies that are included in the trial. There are two goals of this quality check step. First, is to ensure the quality of the images involved in the trial by reviewing the image compliance to acquisition protocol and the existence of image artefacts. These items ensure the accuracy and reliability of the quantified imaging biomarkers. Second, to reduce the number of excluded subjects that have not followed acquisition protocol or have image artefacts.

Finally, QUIBIM services include the notification of any medical image quality discrepancy to the sites. Also, QUIBIM offers image acquisition protocol design consultancy and clinical monitoring.

HK: What advice would you give to trial sponsors looking to outsource their biomarker activities?

IMR: Imaging biomarkers are an important tool that have to be introduced in clinical trials. The main advice that I give to them is that they should select a company that includes the centralized medical imaging management and storage in their services. Additionally, it’s important the company offers quality assurance of images and queries management, and consultancy services, such as image acquisition protocol design and statistical data analysis.

Also, it should include a centralized medical expert reading and quantitative image analysis for the objective quantification of drug safety and therapeutic effectiveness.