When preparing for a large Phase 3 trial, many small companies may need a Big Pharma partner to help them through the process. But how do you connect with large companies? And what are the best practices for working with them? A panel at the 2018 Clinical Leader Forum in Philadelphia attempted to bring some clarity to those questions.
If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments?
The FDA published a new draft guidance on August 10, 2018 entitled, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. The comment period for the draft guidance closed on October 12, 2018 and approximately 20 comments were submitted to the docket. The guidance provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs.
The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?
The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.
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.
With the existence of new tools from cross disciplinary teams - applying innovation in study design, use of patient registries, and partnering with patient advocacy groups - the work for effective therapies continues.
An evaluation of the effect of hemolysis, icterus and lipemia on chemistry assays and further assessment of the association between the amount of interfering substances and ordinal values reported by the automated chemistry analyzer as H-, I- and L-indices.
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In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved.
Trial Interactive turns 10 this year and we could not be more proud—from an early eTMFinnovator to an end-to-end e-clinical platform, we’ve grown tremendously. Part of that growth was in realizing early that effective e-clinical innovation is powered by partnership and collaboration, which has been possible with 25+ years’ experience in the life sciences industry and 10 years of experience in e-clinical innovation.
Patti Arsenault, Cytel's Global Head of Data Management, shares her thoughts on the three core elements important for the success from the data management standpoint - effective timeline management, thoughtful database design, and a proactive approach to data cleaning.
Highlights from Adam Hamm, Director Biostatistics at Cytel, presentation on best practices and operational considerations for adaptive designs and interim analyses.
In the new era of big and complex data, conventional methods of solving search problems are sometimes ineffective.Genetic algorithms provide a highly effective solution to many such problems, and therefore their popularity and adoption are on the rise.
