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Evolution of the UK Legislative Framework for Clinical TrialsNew proposals aim to create higher standards for trial regulation.
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Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular DystrophyApproaches sponsors, CROs, and investigators can take from the DMD experience.
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Survey Results: GCP Quality and Risks in Decentralized Clinical TrialsIdentifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.
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Considerations to Reach Underrepresented GroupsRegulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.
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How to Navigate the Clinical Trial Complexities in a Post-COVID WorldWith various COVID-19 vaccine trials underway, a seamless clinical research process has never been more critical.
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How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and RetentionExamining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
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Scaling eSource-Enabled Clinical Trials: Hospital PerspectivesThe challenges, opportunities, and strategic outlook for oncology research centers.
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Aligning Patient Burden with Planetary BurdenHow making trial participation easier can reduce the impact on the environment.
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The Compounding Power of Training: Early Investment Yields Exponential ReturnsWhy investing in truly effective training from the outset can pay off exponentially for clinical teams—and serve as a strategic advantage.
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Initial Design Considerations for Immuno-Oncology TrialsPerspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies.
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How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial ResearchWhile there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
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When Trials Stumble, Mobile Research Nursing Lends a Helping HandWith the assistance of mobile research nursing, in-home visits provide solid alternative to trial participants, especially during COVID-19.
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Leveraging AI/Machine Learning as an End-to-End DifferentiatorA well-designed approach can benefit clinical trials from protocol design to site support.
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Make Your Clinical Trial a Priority in a Busy LandscapeA more crowded space is presenting new challenges for stakeholders that must be addressed to improve efficiency.
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The Impact of Decentralized and Hybrid Trials on Sponsor and CRO CollaborationsTufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.
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Properly Training Physicians in Dermatology TrialsPoor representation of dark skin tones in textbooks emphasizes need for change.
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Better Patient Engagement Begins With Electronic Informed ConsentWhile eConsent has become more widely adopted since COVID-19, work still needs to be done in improving patients’ understanding.
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Addressing Challenges With Intelligent Point-of-Care Device DeploymentKey challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting.
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Changing the Face—and Faces—of Clinical ResearchThe six steps to designing a successful diversity action plan for a clinical trial protocol.
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The Importance of Simple Clinical Trial DiariesSponsors can simplify diaries by taking a closer look at the three common sources of complexity.
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Increased Digitization in Clinical Trials: Expectations for the Year AheadTop predictions for the major trends that will shape clinical trial design in 2022.
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Just How ‘Real’ is Real-World Data?Addressing sources of tension on differentiating types of data.
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Self-collection of Blood Specimens in Clinical TrialsOperational and patient burden considerations for self-collection of blood specimens in clinical trials
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Simultaneous New Drug Submissions: Is it Possible?A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.
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eSource Interoperability Between EHR and EDCEvidence from a Phase III cancer trial points to notable advances in data-transfer tech.
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Evolving Toward Empowerment: How We Are Deepening Relationships With PatientsMultilayered strategies such as working with patient advocacy organizations and leveraging technology can help industry better partner with patients.
