NEW YORK--(BUSINESS WIRE)--Oncology is leading the precision medicine revolution, as clinical researchers leverage and identify biomarkers to target patient subsets with more effective treatments, and the promise of improving Phase I success rate probability by three times (25.9% versus 8.4%)1. Despite these advancements, the industry continues to struggle with issues arising from the increase in clinical complexity and patient scarcity for precision trials. To discuss these challenges and new opportunities, Medidata (NASDAQ: MDSO) is hosting a webinar with FiercePharma, “Optimize and Transform Clinical Oncology Research,” March 20 at noon (Eastern US Time).
During the webinar, special guest speakers will further explore today’s biggest challenges in precision medicine, including Reinhard Von Roemeling, Board Certified Oncologist and former SVP of Global Oncology at Merck KGaA, Robert Ford, M.D., Founder of Clinical Trials Imaging Consulting, LLC, Jason Mezey, PhD, Statistical Genomicist and Professor at Cornell University and Weill Cornell Medical College, and Michele Becci, VP of Industry Strategy at Medidata. The discussion will explore how increasingly transformative technology and advanced analytics are enabling clinical oncology investigators to:
- Optimize study design and streamline operations, minimizing site and patient burden
- Improve site selection and patient enrollment & retention with multivariate models
- Accelerate study conduct, data capture & standardization, and overall operations
- Increase success of study approval for targeted therapies
“Technical advances including monitoring devices with direct data transmissions into large, growing databases and analysis of disparate data will enable the creation of increasingly precise and relevant historical controls for decision making,” said Reinhard Von Roemeling, Board Certified Oncologist and former SVP of Global Oncology at Merck KGaA. “The integration of validated predictive biomarkers with other data streams is essential as it will influence novel designs and enable the success of precision oncology trials.”
In addition, Medidata has made available a white paper, Precision Oncology Trials: A Look Ahead, which outlines major challenges the drug developers are facing with precision oncology, including scarcity of patients available for targeted therapy trials. As large datasets are used to cluster patients into more precise subsets, investigators will have to measure patients on several dimensions, ranging from genotype to phenotype (including, genotype, laboratory data, digital biomarkers, sensor data, behavioral data).
“The discovery of oncology therapies is continuing at an unprecedented pace,” said Michele Becci, vice president of industry strategy at Medidata. “Medidata's unified platform empowers clinical teams to drive more effective and efficient research, and speed delivery of targeted cancer therapies to patients who need them.”
The Medidata Clinical Cloud® provides comprehensive analytics and technology to tackle today’s challenges impacting precision medicine. Medidata’s unified eClinical platform includes the Rave Data Capture and Management family of products, which seamlessly captures and integrates the abundance of data streams and biomarker measurements that targeted therapies demand, from clinics and labs to sensors, apps, images, genomics and RWE (Real World Evidence). On the same platform, the Edge Trial Planning and Management family enable the research team with historical benchmarks and automation capabilities to optimize patient burden, site selection, grants, and payments. All Medidata product families are powered by the Medidata Enterprise Data Store (MEDS) - the most modern, scalable data backbone available in research, which allows sponsors and CROs to collaborate, powering cross-sponsor, cross-study analytics.
Medidata's unified platform, pioneering analytics, and unrivaled expertise power the development of new therapies for over 1,000 pharmaceutical companies, biotech, medical device firms, academic medical centers and contract research organizations around the world. The Medidata Clinical Cloud® connects patients, physicians and life sciences professionals. Companies on the Medidata platform are individually and collaboratively reinventing the way research is done to create smarter, more precise treatments. For more information: www.mdsol.com
1 Clinical Development Success Rates 2006-2015, BIO, Biomedtracker, Amplion