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Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. Krumholz, MD, SM)

Rethinking Clinical Trials

Pfizer provided feedback. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. -Can you comment on the decision to make the PROMIS scale the primary outcome? Does it capture most what matters to patients?

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Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Rethinking Clinical Trials

Participant feedback revealed that shorter more targeted surveys focusing on the most high-value information may have been less burdensome for participants. pctGR, @Collaboratory1.

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

GCTC will publish its comments at goodtrials.org and the public is encouraged to submit feedback as the work continues to improve the guidance. We encourage people to review the guidance and provide feedback. This could stifle innovation and quality when new and different technologies are more relevant.

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

GCTC will publish its comments at goodtrials.org and the public is encouraged to submit feedback as the work continues to improve the guidance. We encourage people to review the guidance and provide feedback. This could stifle innovation and quality when new and different technologies are more relevant.

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Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)

Rethinking Clinical Trials

The team collected focus group feedback from patients and clinicians and worked with IT professionals to pull data directly from the electronic health record and design an interface that could be used by all patients. . However, there is a gap between collecting the PROs and communicating about the PROs with patients.

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Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Rethinking Clinical Trials

Nudge also deployed a text message and survey to participants to get a sense for patient satisfaction with feedback on the study and text messages. About 50% of participants responded with a question, and 9.2% responded with a question for a clinical pharmacist. – How did the messages account for prescription dosage changes?

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Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)

Rethinking Clinical Trials

There was a 1-page data collection sheet that trained site-specific observers completed with rapid feedback from research team on data quality. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W.

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