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Where Do We Go From Here?Lessons from six months of conducting clinical trials during the COVID-19 pandemic
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What Does Racial Color-Blindness Mean for Clinical Trial Participation?Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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The Future of Cardiac Safety: How Wearable ECGs Enhance Patient Monitoring in Drug TrialsAs wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.
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Tailored Patient Involvement in Clinical TrialsThe approach of the Cancer Research UK Centre for Drug Development.
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Reviewing FDA’s Proposed IRB and Informed Consent Rule Changes21st Century Cures Act prompts FDA to harmonize regulations.
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Scale Your Top Digital Stars in 2024—Not Just Generate New OnesScaling seven common digital programs inside a typical top 10 pharma company could be worth $1.4 billion to $2.2 billion in operating income over five years.
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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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Navigating Evolving DEI Measures in Clinical Patient Recruitment: A Deep DiveIt is crucial throughout the clinical trials space to understand the challenges and triumphs of DEI.
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AI and Digital Technology in Regulatory SubmissionsA tool-based approach can significantly aid in the harmonization of regulatory requirements, mitigate inadvertent risks, and encourage collaboration by making data sharing more efficient and secure.
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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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Clinical Trials and TrustUnderstanding the role of social determinants on clinical trial participation and trust.
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Rethinking ECOG Scores to Improve Patient Access and Clinical Trials EligibilityRecent study results highlight need for new metrics in ECOG scoring to mitigate variability.
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Effect of AI/ML, Real World Evidence and Master Protocols on Trial SuccessHow the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.
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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.
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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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Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial DataPresenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.
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COVID-19 Pandemic Exemplifies the Benefits of CROsThe adaptability and innovative capacity of CROs highlighted in EUCROF survey.
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Breaking Historic Barriers to Ensure Psychedelic Therapy’s FutureEducation and equitable access are key to unlocking its full potential in the present and future.
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Diversity in Clinical Trial Data Transparency: A New Horizon for Data Sharing with Truthful StatisticsThe pursuit of balance between data utility, privacy protection, and equitable representation.
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Real-World Use of an Artificial Intelligence-Supported Solution for Coding of Adverse Events in Clinical TrialsStudy evaluates the use of AI-supported medical coding module.
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COVID-19 Will Have a Heterogeneous Impact on Clinical Trials, BiopharmasA discussion of how the coronavirus pandemic will have a multitude of impacts on the conduct of trials, as well as on the industry itself.
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Establishing the Right Foundation for Patient Safety in 2025How biopharmas are advancing their pharmacovigilance operations.
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Elevating Clinical Research Site Relationships With New Budget and Payment ParadigmsHow a deeper review of site budget and payment processes and technology is driving meaningful change in the industry.
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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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Sample Size Re-Estimation as an Adaptive DesignUsing the promising-zone approach can salvage an underpowered trial.
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Clinical Trial Optionality: Its Reality is Within ReachHow advanced ePRO tools and approaches offer a path forward.
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Enhancing eCOA Through AI: A Look Ahead to 2025The three areas poised for a transformation in the advent of electronic clinical outcome assessment technologies.
