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The Data-Decision Debate: To Share or Not to Share?Exploring the benefits from cross-company data sharing for study planning and investigator selection.
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Phase III Trial Failures: Costly, But PreventableAn examination of recent failures in Phase III studies and innovative approaches to reduce risk.
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Transformative Directions in Oncology Clinical TrialsOver the last decade, many initiatives sponsored by various entities, including academic and clinical research centers have focused on efforts to streamline clinical trial eligibility and data collection. Oncology trial design is no exception as endpoints and eligibility criteria have also changed with the value of the data generated in early phase studies.
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Simplifying eSignaturesWith the healthcare industry’s transition from paper to digital, verification is changing beyond that of a signature in ink. Electronic signatures are a new medium in clinical trials that the industry is now turning to in this transition to digital.
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Clinical Trials in Eosinophilic Esophagitis (EoE) - Advances and Opportunities with this Rare DiseaseEosinophilic esophagitis (EoE) is a rare esophageal condition that currently has no FDA-approved medications resulting in major gaps in treatment. Therefore, the need for better options and opportunities for drug development is apparent.
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Getting There: A Behind the Scenes Look at Cancer MoonShot 2020 - ACTThe Cancer Moonshot 2020 Initiative has been a long time coming for the team working to develop the program’s infrastructure and logistics. Following years of planning the result has been an increased response in the belief that a vaccine-based immunotherapy to battle cancer will be available by 2020.
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It’s Never Too Early for Cold Chain Planning for Cell TherapiesWith cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.
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Monoclonal Antibodies: Clinical Pharmacology KeysOutlining the unique pharmacokinetic factors that should be considered when designing and running early stage clinical trials for monoclonal antibodies.
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Gastroparesis Treatment: What’s Coming Up NextGastroparesis patients face a series of symptoms for which there is currently a significant void in treatment. With complications and questions aplenty, answers are in high demand as physicians search for suitable medicines to combat this disease.
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The Observation Study ConundrumConducting observational studies is becoming a vital part of the clinical trial process, but research teams often struggle to operationalize these more creative and non-traditional study methodologies.
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Benefits of a Combined eCOA/eConsent SolutionTechnology platforms are today continually being adapted into the clinical trial life cycle with the promise of efficiency and reduced risk. CRF Health believes its combined eCOA/eConsent solution could improve the flow of documentation between investigators and sponsors.
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GERD Treatment: Where We Went WrongPatients of gastroesophageal reflux disease (GERD) that have been frequently diagnosed, or misdiagnosed, have been dissatisfied with the available treatment. To resolve this issue, industry players must define meaningful endpoints for future trials, incorporate patient reported outcomes, and apply biomarkers.
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Interexpert Agreement on Adverse Events’ EvaluationStudy measures the differing judgment levels between clinical investigators and drug safety experts.
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Eyes Play a Focal Role in ResearchTwo unique techniques help characterize pharmacodynamic drug effects in healthy subjects.
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Smoother Regulatory Process for ChinaOne year ago, the China Food and Drug Administration (CDFA) was pushed to accelerate its activities to promote new or updated regulations and guidelines. Since then the results have been smoother processes for innovative drug development in China.
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Remote Monitoring of Patients in Clinical TrialsInvestment in mHealth and the adoption of wearables are significant initiatives that are changing the clinical trial process toward a more patient centered approach. These wearable technology initiatives have the potential to be the most innovative advances in drug development.
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Why CRCO is the Key to Increasing Patient-CentricityThe clinical trials space has shifted to a patient friendly, fast and easy process thanks to technological improvements, despite some gaps in the existing model. A Clinical Research Care Option (CRCO) can fill these gaps by fostering a more inclusive clinical research environment.
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UCLA Studies Participant PaymentA critical challenge that clinical trial researchers face is patient drop out. Why patients fail to complete studies can be attributed to a variety of reasons, and delays in compensation can often be one of them.
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Specialized Travel Services Can Help with Patient RetentionClinical trials endure high drop out rates due in part to long schedules, high travel costs and long reimbursement times. Outsourcing specialized clinical trial traveling services can help alleviate this concern by allowing sponsors to efficiently manage travel and other expenses.
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The Core of RBM is Centralized MonitoringThe use and awareness of risk-based monitoring is now impacting clinical trials of all sizes, indications and types as a core component more than ever before. Sponsors and sites are expected to expand its use to include all phases of clinical research and all therapeutics areas.
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Functional Dyspepsia: Can We Get the Trial Design Right?Functional dyspepsia is noted globally as being a common condition that currently has no specific therapy despite years of research. This condition is in need of an operational definition so that drug development and treatment trials can move forward with a more definitive trial design.
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Using Technology to Support NIH PolicyIndustry professionals are searching for new technologies to support their trials following approval of an NIH policy supporting single IRB practices. Transparent and auditable systems can offer stakeholders the ability to more effectively monitor and report regulatory responsibilities.
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What do Patients Want When Interacting with eDiaries? A 3-Part SeriesThis 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 3 covers how sponsors can humanize eCOA to help increase patient engagement during clinical trials.
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5 Reasons it’s Time for a Universal Standard of Knowledge in Clinical ResearchDue to mistakes by research professionals, clinical trials have been subject to delays or even cancellations. The National Board of Medical Examiners is working to reverse this trend by introducing an assessment to test the knowledge of clinical researchers.
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5 Reasons it’s Time for a Universal Standard of Knowledge in Clinical ResearchDue to mistakes by research professionals, clinical trials have been subject to delays or even cancellations. The National Board of Medical Examiners is working to reverse this trend by introducing an assessment to test the knowledge of clinical researchers.
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European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
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European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
