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Accelerated DMC Safety Reports for Biotech’s Central Nervous System Studies: A Case Study
janvier 19, 2024
Independent data monitoring committees help to ensure patient safety and uphold trial integrity. In Central Nervous System (CNS) studies, independent data monitoring is especially critical due to challenges such as patient enrollment, rater variability, and placebo response rates. The right DMC provider can help overcome these challenges and optimize the clinical research approach.
The following case study illustrates how a clinical-stage biotechnology company developing novel medicines to address CNS diseases was concerned about the management and assessment of their study data. To navigate this critical phase, the biotech selected Axio, a Cytel company, as an independent statistical center to provide DMC support for their ongoing studies.
Download the case study below to learn how partnering with Axio enabled the client to expedite their DMC safety reports, all while maintaining the highest standards of patient safety and trial integrity.
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David Kerr
DMC Biostatistician Director
David Kerr is a DMC Biostatistician Director at Cytel. He has dedicated 28 years to Axio Research, a Cytel company. David is a leader in Axio’s DMC services, which facilitate more than 500 DMC meetings annually. He played an instrumental role in developing SOPs that govern Axio’s DMC services. In addition to his duties as DMC Biostatistician Director, David has provided statistical support as the reporting statistician for more than 250 DMCs covering 300 individual clinical trials. His expertise spans disease areas such as oncology, cardiology, infectious disease, respiratory disease, and rheumatology. He has attended over 1000 DMC meetings, becoming a strong advocate for improving DMC processes. He regularly presents at conferences and conducts industry tutorials to ensure DMCs are equipped with the best information to make educated recommendations, prioritizing both trial success and participant safety.
David received his Master’s in Statistics from the University of Washington and is based in Seattle, Washington.
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