Perspectum’s new whitepaper clearly outlines how the upfront cost of pre-screening subjects for NASH clinical trial enrollment with non-invasive, MRI-based imaging biomarkers can be significantly offset by the costs saved due to the reduction in total number of biopsies required for trial enrollment.
Non-alcoholic steatohepatitis (NASH) presents a major challenge in drug development. To date, just a handful of NASH drugs have made it to Phase 3 development, and each has experienced either recruitment delays or changes to endpoints mid-study. Although it appears some sponsors may have charted an earlier course to success to the first FDA approved NASH drug, the shifting clinical trial landscape and increasing competition for qualified trial participants demands companies continue to run smarter, faster, and leaner clinical trials if they are to successfully navigate towards an approved NASH drug.
The diagnosis and identification of qualified participants for NASH clinical trials is notoriously difficult due to a long asymptomatic period and mandatory, invasive screening biopsies. Furthermore, current guidance requires histological endpoints despite the inherent limitations of biopsy such as the qualitative nature of the evaluation. Knowing how to integrate the right imaging tools into NASH trials gives sponsors the enhanced screening and monitoring capabilities needed to successfully develop an approved NASH drug on accelerated timelines and within budget. Non-invasive, MRI-based biomarkers are the most cost-effective and reliable tools to screen subjects for NASH and monitor the efficacy of interventional therapies.
LiverMultiScan® is a non-invasive, patient-friendly MRI examination that can accelerate trial recruitment, enrich the subject population, and provide efficacy signals within 6 weeks and indications of long-term clinical outcomes. This new whitepaper outlines how to cost-effectively incorporate Perspectum’s proprietary corrected T1 (cT1®) biomarker into NASH clinical trials in order to lower enrollment costs, accelerate drug development, and reduce the burden of invasive testing on trial participants.
About Perspectum
Perspectum delivers cutting-edge digital technologies that help provide better care for patients with liver disease, diabetes, and cancer. Our specialized CRO capabilities help pharmaceutical sponsors accelerate drug development in order to bring better therapeutic options to patients sooner. With a diverse team of physicians, biomedical scientists, engineers, and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com
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Source: Perspectum
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http://www.businesswire.com/news/home/20201028005136/en
