Remove tag planning-and-design
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Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. Hughes, PhD)

Rethinking Clinical Trials

Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Slides Keywords Design, Analysis, Stepped-Wedge Trial Key Points Stepped-wedge design is typically run by clusters that are randomized. Each of the clusters receive the control and treatment, and each cluster is sequenced to the intervention at different times.

Trials 152
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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

Most, if not all, of these therapies used the FDA’s Orphan Drug Designation to aid their development plans. So far this year, 176 drugs have already received this designation. Have orphan drug designations increased in recent years? Prior to the program, only 10 drugs were approved for a rare disease.

Drugs 246
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Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Rethinking Clinical Trials

Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. One of the key features was that implementation measures were to be used as primary outcomes.

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Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)

Rethinking Clinical Trials

Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design. Implementation mapping at the beginning of the design process is key.

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Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. Koopman, MD, MS)

Rethinking Clinical Trials

The team’s goals were to design for the primary care setting because 85% of hypertension care is in this setting. The team’s goals were to design for the primary care setting because 85% of hypertension care is in this setting. Koopman, MD, MS Jack M. and Winifred S. The primary outcome is blood pressure at 6 months. We are paying now.

Trials 130
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Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

Rethinking Clinical Trials

It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico. Both drugs have a well-established safety profile and would be a good fit for a pragmatic design.

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Are You Ready for GA4? Enhancements for Measuring Engagement

Intouch Solutions

GA4 is a new property designed for the future of measurement: Collects both website and app data to better understand the customer journey. “GA4 GA4 is a new property designed for the future of measurement: Collects both website and app data to better understand the customer journey. Uses events instead of session-based data.