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| home > white papers > The Promise and Challenge of Adaptive Design in Oncology Trials - Medpace |
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 WHITE PAPERS |
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Medpace
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The Promise and Challenge of Adaptive Design in Oncology Trials
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Clinical oncology trials are more complex and time consuming than those in any other therapeutic area and failure rates are frustratingly high. Given the urgent need for new oncologic therapies, sponsors are eager to find more effective ways to conduct clinical research.
Incorporating adaptive design methodologies into clinical trials can reduce costs and enhance efficiency while maintaining trial integrity. They can also reduce the number of patients on placebo and sub-therapeutic doses. In light of this promise, regulatory bodies have created guidelines supportive of adaptive design.
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News and Press Releases |
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Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000
Cambridge and Wetherby, UK, 29 November 2021: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase 1 clinical trial, ALS-6000-101, into clinical trial sites in the United States.
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White Papers |
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PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content
Phlexglobal Ltd
Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive.
As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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