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Strategies to Include the LGBTQIA+ Community in Research TrialsRecently there has been an increase and awareness of the long-standing problems with diversity and the inclusion of under-represented populations in clinical research.
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Strategies to Close the Gap in Clinical Trial Recruitment2021 survey highlights challenges and opportunities for investigators, coordinators, and patients.
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AI/ML Approaches to Assisted Medical Writing—Part 2Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.
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Patient and Site Personnel Perceptions of Retail Pharmacy Involvement in Clinical ResearchDespite industry-wide excitement over the involvement of retail pharmacies in clinical research, there is little information currently available on how retail pharmacies are perceived by investigative sites and patients.
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Redefining CRO Sourcing Model Terminology to Optimize Outsourcing StrategiesDifferentiating FSO and FSP approaches can better align definitions of models for CROs and sponsors.
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Accelerating Time to Treatment in Rare DiseaseLife sciences leaders are overcoming challenges to speed the development, launch, and education of novel medicines for rare diseases.
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How to Determine ‘Good Science’ for Systematic Literature Reviews in Clinical Research and DevelopmentBest practices for assessing publications.
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Dialogue with Your Data: Conversational Experience Is the New User ExperienceWith an AI-enabled virtual assistant as part of your clinical research toolkit, deriving insights from clinical data is as simple as asking a question.
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GenAI Use as a Co-Pilot for Regulatory IntelligenceGenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.
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The Benefits and Limitations of Clinical Data PlatformsConsiderations to help tailor new tools as part of a custom clinical trial strategy.
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New Legislation is Driving Diversity in Clinical ResearchIndustry leaders discuss how technology can help companies adapt to the regulatory changes and accomplish their DE&I goals.
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How Decentralized Clinical Trial (DCT) Design Brings Clinical Research as a Care Option to Cancer PatientsEsther Howard, Oncology Advisor at THREAD, will be shedding light on how DCT design brings clinical research as a care option to cancer patients. In 2021, over 608,000 Americans alone passed away from cancer- equating to 1,600 deaths a day. Because clinical trials become the only treatment option for cancer patients after they have exhausted all standard of care options, we desperately need solutions to bring real access to clinical trials as a care option to more cancer patients. Esther will focus on some of the challenges that patients face, and how elements of a DCT design can not only save the lives of more patients but can also be a key driver in improving diversity in enrollment.
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Diversity in Clinical Trials: Path to Achieving Health EquityBeyond technology, awareness, and access—cultural competence is key.
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AI Addresses the Complexities of Cancer Trials for Patients and PharmaStudy designs, coupled with difficulties finding, enrolling and retaining trial participants, further intensify operational challenges and prevent new treatments from getting to market.
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Getting IRT Right – Part 2: Study Drug Allocation and Supply ManagementIn an earlier article, we reviewed the randomization risks that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly. Here we address the consequences that trial sponsors could face if their IRT system isn’t adequately designed to handle the many and often complex drug allocation and trial supply aspects of their clinical trials.
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What the Future State Really Looks Like for Clinical Data LeadersAccelerating trends in clinical data are forcing changes in strategy.
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Adapting Site Selection for Clinical Trial Decentralization and the Future LandscapeSites not expected to fade away even as DCTs continue to grow past COVID-19.
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A Review of Critical Issues Detected Via Central Statistical MonitoringAnalysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.
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We Must Do More to Ensure Women Achieve Their Professional GoalsWith poor retention of women in the biomedical workforce amid the pandemic, industry leaders in clinical research must step up to provide solutions.
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The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in ChinaFollowing the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
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Are You a Victim of Clinical Trial Fraud? If So, What Are Your Rights and Obligations?Aggressive focus by DOJ has put increased burden on stakeholders to understand their obligations and exposure.
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Clinical Trial Technology: New Kids on the Block are Changing Industry DynamicCOVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration—but progress remains measured.
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Establishing Metrics and Standardization for Non-CRF Data in EDCWhile Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
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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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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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Oncolytic Virus Immunotherapy: A Brief Overview and Considerations for Clinical Trial PlanningSuccessful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.
