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The IDEAS InitiativeImproving diversity, education, and advancement in studies: a look at the IDEAS initiative.
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The Changing Landscape of Cystic Fibrosis Clinical TrialsChanging demographics and evolving standards of care bring additional challenges when creating protocol designs.
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Improving Clinical Trial Enrollment Forecasts Using SORMA useful tool for clinical research professionals to estimate potential recruitment duration.
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Draft NIH Policy on the Use of a Single IRB for Multi-Site ResearchAt a time of the year when love is in the air, one thing is for sure: there is not a lot of love from the human research community on NIH’s Policy on the Use of a Single IRB for Multi-Site Research.
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Increased Data Transparency Unveils Terminology in DisarraySubject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
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Increased Data Transparency Unveils Terminology in DisarraySubject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
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Increased Data Transparency Unveils Terminology in DisarraySubject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
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Increased Data Transparency Unveils Terminology in DisarraySubject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
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Increased Data Transparency Unveils Terminology in DisarraySubject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
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The Remote Patient-Centered Approach in Clinical ResearchIn the healthcare arena, the concept of patient-centeredness has expanded over the last 50 years, beginning as a term to describe patient engagement in self-health management and evolving to include various aspects of patient engagement in healthcare research.1
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Risking it All? Going All in on RBM AdoptionCancer Research UK (CRUK) followed such advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.
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Key Strategies in Sustaining the Investigator PoolThe sharp rise in ongoing clinical research studies is driving demand for greater participation in research by physicians as well as by patients.1
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Integrated Clinical Research Systems: A Chance to ReinventThe organization of healthcare is changing rapidly. The healthcare delivery system is increasingly powered by payers and regulators, and this directs both clinical medicine and drug development. Partly because of this change, the drug development process has been heavily scrutinized, and a great emphasis has been placed on more efficient translation of basic science into useful medicines.
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2020 Vision: Fulfilling the Future of Clinical ResearchIntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.
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2020 Vision: Fulfilling the Future of Clinical ResearchIntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.
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Eliminating ‘Disruption’ for Patients in Clinical TrialsExploring new ways to smooth the path toward better participation for patients and other research and healthcare stakeholders.
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Regulatory Approval in India: An Updated ReviewIssues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.
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Bring Your Own Device for Trial Outcome AssessmentSurvey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
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Syneos Health 2022 Health TrendsInsights from Syneos Health’s 2022 Health Trends: Insights for Industry Change Agent.
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Planning for Success in Late Phase Global Oncology TrialsFollowing four key study-design steps is crucial to the delivery of a successful cross-border cancer study
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Sweeping Aside the Hurdles of EMR and EDC IntegrationHistorically, some longstanding challenges have hindered efforts to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems.
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FDA’s Expedited Review Process: The Need for SpeedOutlining the requirements and benefits of FDA's four expedited drug approval pathways.
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FDA’s Expedited Review Process: The Need for SpeedOutlining the requirements and benefits of FDA's four expedited drug approval pathways.
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Global Biomarker and Companion Diagnostics Outsourcing MarketOver recent years global drug companies large or small have recognized that one root cause of the high failure rate in their clinical development lies in the selection of right therapeutic targets.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Exploring the Role of the Regional CoordinatorHow one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
