Clinical Research Informer

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

AUGUST 30, 2023

Speaker Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Slides Keywords Patient-Reported Outcomes, Rheumatoid Arthritis, EHR Key Points Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA).

Trials

Trials Clinical Research Coordinator Medicine Clinical Trials

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

NOVEMBER 21, 2023

The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement. The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds March 1, 2024: Effect of an Intensive Food-As-Medicine Program on Health and Health Care Use: Evidence from a Randomized Clinical Trial (Joseph Doyle, PhD)

Rethinking Clinical Trials

MARCH 6, 2024

The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. Participants received a $50 gift card for completing the labs and surveys. Clinic staff included a dietitian, a nurse and a community health worker.

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. Although a subset of patients derives long-term benefits from IO therapies, a high percentage of patients still fail to respond or develop resistance to IO therapy.

Genetic Engineering

Genetic Engineering Antibody Clinical Trials Clinical Trials

Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Rethinking Clinical Trials

OCTOBER 18, 2023

Other data, such as immunizations, social determinants of health (SDOH), patient-generated data, and others, may or may not be in the PCORnet Common Data Model and require additional work for use in research. When we talk about patient-level SDOH measures, the CDM has some general purpose tables that can store that data.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Research

Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)

Rethinking Clinical Trials

DECEMBER 12, 2023

For the Jumpstart trial, a number of refinements were made to make it more pragmatic, including the creation of Jumpstart using EHR data rather than patient or family member surveys, delivering the intervention to clinicians only, automated population of Jumpstart guide fields, and automated Jumpstart delivery to clinicians by email.

Trials

Trials Medicine Clinical Trials Clinical Trials

Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. All of the surveys are completed online. There were no differences observed in the relief of mild-to-moderate COVID-19 symptoms between patients taking Ivermectin-400 and the placebo. The study has closed the Fluvoxamine-50 and Ivermectin-600 arms.

Trials

Trials Pharmacy Medicine Clinical Trials

The FDA and Aduhelm: WTF?

World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. government.

Drugs

Drugs FDA Approval Doctors Doctor

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Rethinking Clinical Trials

APRIL 27, 2023

The reasoning for this temperature is unclear, though it likely represents what was considered the average body temperature of most patients. In a recent international survey of more than 270 centers, nearly half now use a cooler temperature dialysate in patient care of less than or equal to 36.0

Trials

Trials Clinical Trials Clinical Trials Medicine

American health is in for a “world of hurt”

World of DTC Marketing

NOVEMBER 3, 2020

The estimates are thought to be particularly reliable, as the team corrected for current underestimates of weight given by individuals in national surveys. Our healthcare system is set up to treat patients not to prevent bad health habits. There are many reasons why Americans are so unhealthy, including socioeconomic circumstances.

Pharma Companies

Pharma Companies Scientist Medicine Research

Pear claims breakthrough tag for alcohol use disorder DTx

pharmaphorum

NOVEMBER 24, 2021

reSET-O was the first prescription DTx ever to win a breakthrough device designation from the FDA, according to Pear , allowing it to tap into a programme intended to speed up the development and regulatory review of new therapies so they can reach patients sooner. Photo by thom masat on Unsplash.

Production

Production Development Trials

Revolutionizing Medicine and Public Health: The Emergence of Big Data in Healthcare

Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

Big Data

Big Data Medicine Marketing Clinical Trials

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

Rethinking Clinical Trials

AUGUST 28, 2023

The American College of Physicians guideline states that “physicians and patients should treat acute, sub-acute and chronic LBP with non-drug therapies.” Patients in the usual care arm clinics are then scheduled to see a PCP. Presenters also shared challenges regarding scheduling and patient insurance coverage.

Trials

Trials Research Medicine Doctors

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

Rethinking Clinical Trials

OCTOBER 31, 2023

PaxLC brings together many innovations including online screening, digital medical record review, e-consent, home-delivery of medications, local clinical blood draws, home-based biospecimen collection, online diaries and surveys, digital medical record outcomes, and participant-centricity, and return of results. Pfizer provided feedback.

Trials

Trials Medicine Research Clinical Trials

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% Previously, the standard of care for obesity consisted of holistic changes to diet, exercise, and bariatric surgery for eligible patients.

Drugs

Drugs Manufacturing Hormones Contract Manufacturing

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% Previously, the standard of care for obesity consisted of holistic changes to diet, exercise, and bariatric surgery for eligible patients.

Drugs

Drugs Manufacturing Hormones Contract Manufacturing

Prescription drug prices are out of cotrol

World of DTC Marketing

JUNE 16, 2021

The pharma industry has been riding a wave of public approval since they developed a vaccine to fight COVID-19, but that goodwill is going to be short lived thanks, in part, to the $56,000 price tag of Biogen’s new drug and insulin that too many people still can’t afford. But changes are coming; it’s only a matter of time.

Drugs

Drugs Branding Medicine Insulin

Clinical Research Informer

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

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)

Trending Sources

Grand Rounds March 1, 2024: Effect of an Intensive Food-As-Medicine Program on Health and Health Care Use: Evidence from a Randomized Clinical Trial (Joseph Doyle, PhD)

A broad range of unmet needs remains in the immuno-oncology space

Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)

Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

The FDA and Aduhelm: WTF?

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

American health is in for a “world of hurt”

Pear claims breakthrough tag for alcohol use disorder DTx

Revolutionizing Medicine and Public Health: The Emergence of Big Data in Healthcare

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

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

The “Medical Bypass”: new drugs to strike obesity

The “Medical Bypass”: new drugs to strike obesity

Prescription drug prices are out of cotrol

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