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Making a Difference in Cancer Trials AccrualThe integration of pre-screening all patients for eligibility in oncology studies.
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Case Study: Confirmation of Fraud - Diaries Completed by StaffIn a phase III trial in vascular disease, over 4,500 patients were randomized across 160 sites.
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A Different Approach to CTMSIn order to manage critical clinical trial information, sponsors and CROs typically implement a strict data management structure...
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Lifecycle Modeling and Simulation in Clinical TrialsHow the application of evolving M&S models are transforming full-research design strategies.
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Artisanal PublishingIn my previous blog "From Science to Fiction" (ACTO, April 15, 2014), I discussed the trials and tribulations of unlearning the scientific writing style...
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Optimizing Clinical Trial Enrollment Methods Through "Goal Programming"Clinical trials often fail to reach desired goals due to poor recruitment outcomes, including low participant turnout, high recruitment cost, or poor representation of minorities.
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From Telex to Terabytes: Using Technology to Optimize Clinical OperationsAs a principal investigator in the early 1980s at University Hospital in Peru, I used to receive instructions and queries from the study team through a Telex machine.
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Cancer Trials: Raising Accrual RatesLessons learned from the recruitment of colorectal cander patients into clinical trials.
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Research in the United KingdomThe current initiatives and a historical overview of the clinical trial landscape.
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Clinical Contracting EfficiencyA simple but overlooked way to save millions of dollars during new drug development.
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Lifecycle Modeling and Simulation in Clinical TrialsHow the application of evolving M&S models are transforming full-research design strategies.
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Lifecycle Modeling and Simulation in Clinical TrialsHow the application of evolving M&S models are transforming full-research design strategies.
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Clinical Trials in the Baltic StatesThe region has an appropriate population size, solid infrastructure, experienced nvestigators, and short timelines.
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Clinical Contracting EfficiencyA simple but overlooked way to save millions of dollars during new drug development.
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Performance Metrics: Optimizing OutcomesA clearly defined set of performance measures is an integral part of the central laboratory selection and management process.
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What Google Can Teach Us About Trial Education, AwarenessSearch-engine data offers window to public consciousness around clinical trial research, participation.
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The Use of a Single Center, Multi-Location Research Structure For Participation in Large Clinical Trials: The Cleveland Clinic ModelAs funding for clinical research trials decreases and sponsors of clinical studies are under increasingly stringent timelines to obtain FDA approval and get new therapies to market, the need increases for well-managed, efficient, and effective clinical trial sites.
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Moving From Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research ProfessionalMedicines development and clinical research are among the most heavily regulated activities on a global basis.
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Clinical Trials and Social NetworkingThere are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’
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Innovation in Ethical ReviewGoing paperless can help an IRB quickly collaborate, share documents, and review protocols.
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Steps for a Successful Clinical Trial Management SystemAs the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.
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Best Practices in IRT Implementation: A Checklist for Asia-PacPharmaceutical sponsors conducting clinical trials in the Asia Pacific region have a rare opportunity at hand...
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Common Technical Document DevelopmentPartnership formation is the new trend in common technical document development.
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Bridging the Disconnect in Pediatric Clinical Trial RecruitmentDespite the growing need for pediatric-approved medications, clinical trial enrollment for pediatrics remains challenging.
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5 Essential Cornerstones of RbM TechnologyOften overlooked in early evaluation of RBM are the tools and technologies required for successful implementation. Without the right tools to track and prioritize the shift from traditional monitoring to RBM, successful implementation is doubtful, posing detrimental consequences not only for the monitors, but also the overall trial.
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The Gene Therapy Product Development ProcessNavigating the many complexities in clinical trials, manufacturing, and regulatory interaction in moving gene therapies from development to market.
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Enhancing Trial Enrollment Through 'Goal Programming'How iterative analysis of subject recruitment data can optimize outcomes during ongoing enrollment.
