Authors
Latest:
Assessing Suicidality in Clinical Trials: Paxil's Wakeup CallThe authors concluded that its secondary analysis of existing data from Study 329 demonstrated clinically significant increases in harms, including suicidal ideation and behavior (SIB) and other serious adverse events in individuals taking paroxetine.
Latest:
Equip Sites in Emerging Markets for RBMInvestigator sites in emerging markets have a different set of challenges from those in developed regions. They cater to significantly larger patient populations, and are often not as well organized for clinical trial conduct.
Latest:
Real-World Evidence StudiesReal-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting. The result is that real-world evidence is now included earlier in the research and development phase.
Latest:
Real-World Evidence StudiesReal-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting. The result is that real-world evidence is now included earlier in the research and development phase.
Latest:
Empower Centralized Monitoring with the Right Mix of KRI and CSM ReportsCentralized monitoring is the core of RBM and helps study teams decide on on-site monitoring activities and site intervention. Thus, the right mix of KRIs and Central Statistical Monitoring Reports is crucial for trial success.
Latest:
Expanding Data Management Services in China: Additional Insights Into a Rapidly Growing MarketEven with the rapid increase in clinical trials and demand for cloud-based systems, doing business in China is not easy if you are unfamiliar with the territory.
Latest:
Placebo Effect of Transdermal NSAIDSThe implications and challenges of the placebo effect on regulatory agency product approval.
Latest:
Risk-Based Monitoring Case Study: Lessons from a 3,389-subject Global Phase III TrialA snapshot of one novel approach in RBM implementation and the data and site performance lessons learned.
Latest:
Developing New Alzheimer’s Drugs With a Focus on Patient SafetyAligning patient-centric approaches with personalized medicine and biomarker use is transforming the design of Alzheimer's trials.
Latest:
Data Protection Regime Change in the EU: The Impact on the Pharmaceutical IndustryAlthough the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.
Latest:
Data Protection Regime Change in the EU: The Impact on the Pharmaceutical IndustryAlthough the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.
Latest:
Data Protection Regime Change in the EU: The Impact on the Pharmaceutical IndustryAlthough the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.
Latest:
ICH GCP Goes Risk BasedIn this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.
Latest:
A Centralized Monitoring Approach Using Excel for the Quality Management of Clinical TrialsPilot study evaluates the success of building quality into clinical trials using a plan-do-check-act (PDCA) approach to quality management.
Latest:
The Basics of Clinical Trial Centralized MonitoringExamining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.
Latest:
Putting Our Shoulders to the Wheel: Thoughts on Data SharingData sharing in biomedical research has recently attracted widespread attention from physicians, scientists and stakeholders alike. DCRIs Dr. Eric Peterson discusses the context, flaws and positives of how this initiative could be implemented and the effects it can have on the industry.
Latest:
Interpretation of Regulatory Requirements by Technology Providers: The Case for Electronic Source DataThe authors contrast two views on the regulations concerning electronic source data.
Latest:
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.
Latest:
Rare Diseases: Meeting the Unique Challenges of Orphan Drug DevelopmentPoor understanding of the natural history of the proposed indication due to few observational studies studying disease progression, heterogeneous patient populations with variable phenotypes and clinical courses, geographic dispersion of patients and investigators, regulatory uncertainties, and lack of prior clinical studies to establish a template for study execution, can all prove challenging in creating a pharmaceutical development program for the treatment of a rare disease.
Latest:
Africa a Ripe Proving Ground for Digital HealthA proposed operational framework to support digital- and mHealth-based clinical trials in Africa.
Latest:
Are Phase III Clinical Trials Really Consistently Behind Schedule?With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Value-Based Planning & Drug Development ProductivityHow to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Latest:
Stumbling Seven Times But Recovering EightJapan is increasingly a region where opportunities for global registration studies abound, supported by government policies as well as the medical community and its local population. However, incorporating Japan as an integral part of your global trial execution strategy does not come without its unique challenges.
Latest:
Could Gamification Improve Clinical Trials?Gamification is the application of game design principles and techniques to non-game contexts intending to create value for players and stakeholders alike. If applied, this principle can potentially drive greater innovation and efficiencies in clinical research.
