Authors
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Tackling the Challenges of Transitioning to RBMMethods sponsors and CROs can use to minimize the growing pains associated with RBM implementation.
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ePRO Not Profitable? Consider a Revenue-Generating Delivery ModelKyle Hogan, Director, eClinical Solutions, Clinical Ink, writes how however promising ePRO may be - its benefits may not be enough to overcome concerns that take an significant period of investment before generating business, patient benefits, and financial returns.
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Randomization Revolution is BrewingSystems that support automated processes have begun to transform the conduct of clinical trials.
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The Cancer Trial Paradox: Too Few Patients to Some, Too Few Trials to OthersWhile obstacles may persist with limited access for patients and researchers, technology can help with this cancer clinical trial paradox.
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Master Protocol Guidance in Cancer R&D: Impact on IndustryFDA draft guidance for modernizing the approach to clinical trial design for oncology drugs and biologics look to make clinical trials more efficient while maintaining patient safety.
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The Importance of Site SelectionCase study focused on quest for potential Parkinson’s biomarker highlights opportunities and challenges in site selection.
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Clinical Data Manager: A Roadmap for the FutureBreaking down the evolving role of today’s clinical data manager-and its importance as a key cog in the clinical research ecosystem of tomorrow.
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Risk-Based Quality Management: The Importance of Risk CommunicationAmid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.
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How to Address—and Overcome—Operational Challenges in Master Protocol StudiesTrials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.
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Technology-Based Patient Focus to Improve Clinical TrialsExploring ways technology can help sponsors improve their outcomes, focusing on the essential but often-undervalued player in clinical research: the patient.
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To Extrapolate Site Enrollment or Not To Extrapolate? That is the Question.Analysis of over 330,000 Phesi trial protocols shows predicting future enrollment performance by extrapolating data is flawed.
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The Well-Adjusted Statistician: Analysis of Covariance ExplainedHow to account and adjust for covariates in clinical trial randomization-and be confident about uncertainty.
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The Case for Response Adaptive Trial Design for Rare DiseasesAs pharma businesses shift their focus away from ‘blockbusters’ to treatments for rare diseases, clinical trial design must also go through a period of change and should consider response-adaptive over traditional randomized controlled trial designs.
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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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MyStudies Platform Brings Patient Experience to Drug DevelopmentMyStudies, introduced by the FDA, bridges data streams to real world evidence by facilitating the collection of real-world data directly from patients in conjunction with a variety of data sources.
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Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
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Leading Clinical ProjectsA survey of clinical research professionals asked: What makes you a successful project leader?
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Key Cost Drivers in Clinical Research: Guide to Successful BudgetingIt's almost impossible to map out study budgets with absolute precision. Planning for the unexpected costs, such as those associated with slow enrollment, protocol amendments, and other contingencies—is vital.
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The Revised Common Rule and New “Concise Summary” RequirementsLinda Reuter, CIP, Director of BRANY IRB, discusses the Revised Common Rule that now requires informed consent to begin with a concise and focused presentation of key information that will help the patient better understand the reasons why they might or might not want to participate in the research.
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Acquiring Medical Guidance in Clinical TrialsA critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.
