Clinical Research Informer

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Rethinking Clinical Trials

JULY 6, 2023

During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Learn more Read more about Decentralized Clinical Trials.

Trials

Trials Clinical Trials Clinical Trials Licensing

June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Rethinking Clinical Trials

JUNE 29, 2022

Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. and the FDA Draft Guidance for RWD/RWE. The post June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH) appeared first on Rethinking Clinical Trials. Associate Director for Real-World Evidence Analytics.

Big Data

Big Data Clinical Trials Clinical Trials Drugs

Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Rethinking Clinical Trials

NOVEMBER 16, 2022

As one of the federal departments and agencies with the largest research and development budget, the NIH came out with one of the first federal data sharing policies in 2003 called the NIH Data Sharing Policy and Implementation Guidance. University of Michigan Medical School. Ethics, Data Sharing, Pragmatic Clinical Trials. Key Points.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

Rethinking Clinical Trials

JANUARY 23, 2024

Feasibility and generalizability affect design choices including inclusion/exclusion criteria, flexibility of imaging intervention being tested, guidance/control of subsequent care after imaging, and endpoints and outcomes. Similar to most types of trials, there are pros and cons to both pragmatic and explanatory designs in imaging trials.

Trials

Trials Cardiology Clinical Trials Clinical Trials

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

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Unnecessary, irrelevant, or ultra-specific guidance can cause more harm than good. We encourage people to review the guidance and provide feedback.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

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

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Unnecessary, irrelevant, or ultra-specific guidance can cause more harm than good. We encourage people to review the guidance and provide feedback.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Rethinking Clinical Trials

SEPTEMBER 28, 2023

The American Academy of Pediatrics (AAP) Bright Futures guidelines for preventive visits include history, measurements, physical exam, developmental and behavioral screening, anticipatory guidance, and psychosocial and social needs screening and guidance. How might we better structure preventive visits?

Trials

Trials Clinical Trials Clinical Trials Research

Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Rethinking Clinical Trials

JANUARY 17, 2024

The committee worked with communications specialists who partnered with palliative care providers and others to draft FAQs and other communication guidance for clinician teams who were having conversations about drug allocations with patients and families. There was a daily process for the Remdesivir lottery.

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

Grand Rounds September 29, 2023: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium (Claire Snyder, PhD; Norah Crossnohere, PhD; Anne Schuster, PhD)

Rethinking Clinical Trials

OCTOBER 2, 2023

Over the last decade, collection of guidance documents and resources have been developed to develop each of the steps in the clinical trial directory. The PROTEUS website has web tutorials, checklists, and a handbook on topics such as displaying data for patients and clinicians and researchers.

Clinical Trials

Clinical Trials Clinical Trials Research Trials

Grand Rounds October 7, 2022: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)

Rethinking Clinical Trials

OCTOBER 13, 2022

What instructions or guidance did you provide for the handover? ? ? ? ? ? ? ?. Speakers. Melanie Meersch-Dini, MD. Department of Anesthesiology, Intensive Care and Pain Medicine. University Hospital Münster, Germany. HandiCAP Trial, Pragmatic Clinical Trial. Key Points. Learn more about the HandiCAP Trial. Discussion Themes.

Trials

Trials Clinical Trials Clinical Trials Nurses

7 Tips for Integrating SMS Texts Into Your Brand Strategy

Intouch Solutions

AUGUST 3, 2021

For example, using keywords can help you track and add subscribers to your program, and making the most of every opportunity to collect data can open new avenues to effectively execute your program. ? Intouch offers a Strategic SMS Playbook full of tips, templates, and expert guidance. Plan your paths. How would someone sign up?

Branding

Branding Doctors Doctor Marketing

Introducing Xtalks Job Search: Recruiting in the Life Sciences Just Got Easier

XTalks

AUGUST 13, 2020

By combining a granular job category search with an optimized keyword search functionality that returns the most relevant results, Xtalks Job Search helps the best candidates find your job postings. Rapid Job Posting. Career Insights Blog. Attracting job seekers isn’t just about providing them with a list of openings.

Life Science

Life Science Packaging Packaging Development

eConsent: What it is and Why your eClinical Software Should Have it

Crucial Data Soutions

JULY 23, 2019

What’s the keyword in informed consent? A few years ago, they released guidance on electronic informed consent. The answer to this question matters greatly in the trial design process. If patient recruitment and retention rates dip too low, the trial cannot continue. . Better understanding of the fine print.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Google’s 2021 Title Shakeup Part 2: Our SERP Title Analysis Study

Intouch Solutions

NOVEMBER 30, 2021

Since then, Google has confirmed this change and provided additional guidance. Gone are the days where content optimized by SEO equates to cramming a bunch of keywords into well-written copy. Specifically, title links (i.e., With that, the Intouch SEO team has assessed the impact of these changes across our pharma clients’ brands.

Branding

Branding Engineer Research Marketing

Clinical Research Informer

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Trending Sources

Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

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)

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)

Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Grand Rounds September 29, 2023: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium (Claire Snyder, PhD; Norah Crossnohere, PhD; Anne Schuster, PhD)

Grand Rounds October 7, 2022: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)

7 Tips for Integrating SMS Texts Into Your Brand Strategy

Introducing Xtalks Job Search: Recruiting in the Life Sciences Just Got Easier

eConsent: What it is and Why your eClinical Software Should Have it

Google’s 2021 Title Shakeup Part 2: Our SERP Title Analysis Study

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