2024 FDA DCT Guidance
Clinical ink provides insights for the 2024 FDA’s Guidance for Conducting Clinical Trials with Decentralized Elements Decentralized Clinical Trial (DCT).
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Blog
eConsent: Why Language Matters
The article emphasizes key considerations like ensuring terminological clarity to prevent misunderstandings, the importance of transparency in communication, and how these factors collectively influence stakeholder understanding and acceptance.
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New Approaches to Adherence and Prevention of Dropouts: the Digital Era of Patient Engagement in Cardiometabolic Trials
This article describes how behavioral science can be applied in cardiometabolic clinical research to augment drug interventions. This combined approach addresses the Health Inequity gap while also increasing patient engagement.
Navigating Patient-Reported Outcome (PRO) Data in Cancer Clinical Trials: Insights from the FDA’s Latest Guidance
The recent FDA publication “Submitting Patient-Reported Outcome (PRO) Data in Cancer Clinical Trials” represents a significant leap forward in cancer research and drug development. This detailed guidance for integrating PROs into the drug approval process sets a new standard for the evaluation of cancer treatments.
Human Interaction: Risk-Mitigation Recommendations When Using Technology in Clinical Trials
Technological advancements have broadened the reach of clinical studies to larger and more diverse populations. However, technology alone isn’t sufficient to guarantee successful trial outcomes. The human element, including how technology is utilized by sites, sponsors, and patients in accordance with regulatory guidelines, remains pivotal in ensuring compliance, minimizing risks, and upholding patient safety.
Rethinking eCOA Review: A Shift Toward Efficiency and Ethical Oversight
There is an ongoing debate about the most efficient and ethical approach to reviewing electronic Clinical Outcome Assessments (eCOA).
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5 Key Takeaways from Recent FDA Draft Guidance on Decentralized Clinical Trials (DCTs)
Decentralized Clinical Trials (DCTs) have changed the way clinical research is conducted, transforming traditional approaches and introducing innovative methodologies.
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Unlocking New Possibilities with Continuous Glucose Monitoring in Diabetes Clinical Trials
Effective management of blood glucose levels is crucial for individuals with diabetes to prevent complications and improve their quality of life. However, traditional methods of glucose monitoring are often inconvenient, inaccurate, and incomplete.
Harnessing Continuous Data to advance Clinical Discovery
When patients present for treatment at a clinic, physicians are trained to combine the results of objective assessments with their general observations to form a more complete picture of the patient’s health status.
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Enhancing Oncology Model (EOM): A Patient-Centered Approach to Transforming Cancer Care Delivery
The Enhancing Oncology Model (EOM) is a voluntary, patient-centered healthcare payment model developed by the Centers for Medicare & Medicaid Services (CMS) to improve cancer care delivery and outcomes while reducing costs.
The Three Perils of Wearable Data
Sponsors considering using data from sensors and wearables in their clinical trials worry about three scenarios: collecting too little data, collecting too much data, and collecting bad data. Each outcome could likely impact their study or a portion of it with a significant waste of time, money, and patient goodwill.
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From Data to Insight: Leveraging Technology for Clinical Trial Success
Clinical Ink’s Chief Innovation Officer, Joan Severson, joined a group of panelists on The Real Chemistry podcast during this year’s SXSW to provide insight into how the use of innovative data sources for clinical trial recruitment has become increasingly important in recent years.
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