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EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for SponsorsFrom 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.
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International Patient Recruitment: The Grass is Not Always Greener AbroadThere are several important factors which should be considered prior to resorting to international patient recruitment.
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Final Guidance on IRB Written Procedures IssuedThe Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.
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Final Guidance on IRB Written Procedures IssuedThe Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.
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Five Steps to Making Your Clinical Trials Patient-CentricCompanies can utilize the following five tools to set themselves up for a successful trial.
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As Clinical Trials Go International, Operations Go DigitalAs international outsourcing continues to drive the parties contributing to clinical trials farther apart, technology will increasingly serve as a means of bringing them closer together.
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When is it Time to Kill Your Drug? Maybe Sooner Than You ThinkPatients stand to lose the most when sponsors hold too tightly to drugs doomed to fail. This wastes precious time that patients don’t have and squanders valuable resources.
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Does PI Certification Make a Difference?Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.
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Does PI Certification Make a Difference?Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.
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AACR, ASCO Bring New Insights to Liquid BiopsyLiquid biopsy, typically non-invasive blood-based tests for circulating tumor DNA and circulating tumor cells, has been long-hyped as a potential game-changer for cancer treatment.
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Are Clinical Trial Data Shared by the EMA Under Policy 0070 Really Public Data?The general assumption that the Policy 0070 data releases were public data releases can be challenged since there is a mechanism to enforce the ToU, and this mechanism will continue to exist after the Agency moves to the Netherlands.
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Direct-to-Patient Trials: Address Your AudienceCBI Conference Producer, Trevor Sosvielle, recently sat down with Matthew Amsden, CEO of ProofPilot to discuss his early work in HIV prevention trials. Amsden shares how these experiences helped shape ProofPilot and its patient-centric clinical trial approach.
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Can Sponsors Answer 6 Questions Regulators Ask During Audits?Switching from paper records to an electronic drug accountability IRT system can benefit sites during FDA trial site audits.
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Patient Value Creation & Pharmaceutical R&D PrioritizationJames Man considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.
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What ICH E6 (R2) Means for Investigative Sites, Risk Assessment and Clinical Trial MonitoringThe last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.
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What ICH E6 (R2) Means for Investigative Sites, Risk Assessment and Clinical Trial MonitoringThe last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.
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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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Just Buzzwords or Can Innovative Technologies Truly Transform Clinical Trials?Looking beyond the hype to see how innovations such as data, techniques, and technology can be brought together to improve the lives of patients.
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How to Detect, Manage, and Report Fraud and Fabricated Clinical Research DataThis article will examine the ways to detect fraud and data fabrication within a clinical trial.
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To Sign or Not to Sign FDA Form 1572?Exploring that pivotal question for clinical investigators, sponsors, and global CROs.
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Prioritizing the Patient VoiceAMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling the patients voice.
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How to Manage Machine Learning Algorithms in Clinical TrialsMachine learning algorithms can be used to both manage the complex outputs in clinical trials and make those trials move faster with less risk, reducing timelines, and minimizing expenses.
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Global Risk Based Monitoring: An Invite from Oxford and Duke ResearchCBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.
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Global Risk Based Monitoring: An Invite from Oxford and Duke ResearchCBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.
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Key Strategies CRA’s Use to Maintain Good Clinical PracticesMichael Sydes outlines some strategies that CRA's can use to maintain good clinical practices.
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The Importance of Age Diversity in Clinical TrialsAge diversity in clinical trials benefits both the patient experience and the success of the trial.
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Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They HelpThis article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.
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How to Avoid Common Pitfalls of Market LandscapingKey tips and resources to help evade the common traps of market landscaping-today an increasingly high-stakes and comprehensive task during clinical development.
