Clinical Research Informer

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

Rethinking Clinical Trials

OCTOBER 11, 2023

They also learned that consensus is lacking in many areas, such as blinding and adaptation, even among the implementation research community. Discussion Themes -You previously mentioned that the practice of blinding is extremely common in clinical trials and less so in implementation studies. Yes, that’s one solution.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease – Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)

Rethinking Clinical Trials

FEBRUARY 13, 2023

The NITRIC Trial was a double blind, multicenter, randomized, parallel-group trial recruiting at 6 pediatric cardiac surgical centers in Australia, New Zealand, and The Netherlands. All other surgical staff were blinded. The intervention was applied by perfusionists at a steady concentration from the start until the end of bypass.

Trials

Trials Clinical Trials Clinical Trials Research

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

Intouch Solutions

NOVEMBER 30, 2021

blue links) of the organic results appeared to be pulling from content outside of the HTML title tag at a much higher frequency. SERP Titles vs H1 Elements Comparisons: SERP Titles were compared to the page’s title tag and H1 element for each date range. Aim for title tags between 45 and 60 characters. Considerations.

Branding

Branding Engineer Research Marketing

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Rethinking Clinical Trials

DECEMBER 20, 2023

Can we use blinded HER-led recruitment efforts to identify participants? Tags #pctGR, @Collaboratory1 The post Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC) appeared first on Rethinking Clinical Trials.

Clinical Trials

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Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Rethinking Clinical Trials

MAY 25, 2023

Patients and clinicians were non-blinded. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD) appeared first on Rethinking Clinical Trials. The primary outcome was all-cause mortality.

Trials

Trials Clinical Trials Clinical Trials Compliance

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

EHR passages were adjudicated in pseudo-random order, blinded to patient ID. In order to classify a patient with goals of care conversation, the study used the NLP to screen the records and pull out excerpts of EHR that had high probability to contain a goals of care conversation and then conducted a human review.

Trials

Trials Medicine Clinical Trials Clinical Trials

Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

Rethinking Clinical Trials

DECEMBER 6, 2022

For the step-down RCT, patient recruitment started in August 2019 with 587 patients consenting and 552 included in the primary analysis. It was a labor of love; the site payment was low; we asked friends to be sites in the trial. Sites have a lot of trials that are competing. One pays more than another. pctGR, @Collaboratory1.

Trials

Trials Clinical Trials Clinical Trials Compliance

Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. . CHENGDU, China , Feb.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

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

There are also concerns that the ICH document fails to include scientific issues encountered quite often, such as allocation concealment, randomization, loss-to-follow-up, blinded evaluation of endpoints and others. There are also some excessive details on data, records and computer systems, which are unlikely to stand the test of time.

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

There are also concerns that the ICH document fails to include scientific issues encountered quite often, such as allocation concealment, randomization, loss-to-follow-up, blinded evaluation of endpoints and others. There are also some excessive details on data, records and computer systems, which are unlikely to stand the test of time.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. About Trimer-Tag © Technology. About COVID-19 S-Trimer Vaccine. S-Trimer is intended to be adjuvanted.

Vaccination

Vaccination Vaccine Immune Response Protein

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

JUNE 9, 2021

Aducanumab Controversy and Price Tag. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging trials in patients with Alzheimer’s disease. Evidence for aducanumab’s efficacy has been highly contested. Clinical Evidence.

Drugs

Drugs Clinical Trials Clinical Trials Trials

Bluebird Bio’s Skysona Receives FDA Approval and Becomes World’s Most Expensive Drug

XTalks

SEPTEMBER 27, 2022

The condition causes devastating, irreversible neurologic decline, including significant functional disabilities such as cortical blindness, loss of communication, the need for tube feeding, total incontinence, wheelchair dependence or complete loss of voluntary movement. Related: Bluebird’s $2.8M

FDA Approval

FDA Approval Gene Therapy Drugs Gene

New Rare Disease Drugs and Research Advancements

XTalks

FEBRUARY 27, 2024

Technologies like CRISPR-Cas9 have revolutionized the potential for gene editing, offering hope for curative treatments for conditions like Duchenne muscular dystrophy (DMD) and certain types of inherited blindness. In 2020, 31 out of 53 novel drug approvals were for rare or orphan diseases.

Research

Research Drugs Gene Therapy Clinical Trials

Spade SB-66

The Pharma Data

MAY 13, 2021

After all, the ingredients we’ve chosen to include in Spade SB-66 are premium ingredients and come with a hefty price tag. Efficacy and tolerability of Merastin - A randomized, double-blind, placebo-controlled study. Even though, I actually don’t think they’re being totally unreasonable…. This isn’t controversial science…. Program No.

Packaging

Packaging Packaging Containment Production

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

Rethinking Clinical Trials

NOVEMBER 9, 2022

They also included a message from the fellowship program director or leadership. Forty-four programs participated. If a patient is approached by a fellow, the perspective of the fellow is to prioritize patient care, so there is a built-in level of trust that may come with that and is something we want to explore more. pctGR, @Collaboratory1.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

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

Tags #pctGR, @Collaboratory1 The post Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. One of the main reasons we turn people away is because they are taking a medication that does not work with Paxlovid. Krumholz, MD, SM) appeared first on Rethinking Clinical Trials.

Trials

Trials Medicine Research Clinical Trials

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Pfizer and Lilly will continue to work with the FDA as it continues its review of the application. The information contained on our website or any third-party website is not incorporated by reference into this earnings release. View source version on businesswire.com : [link]. Amy Rose 212.733.7410. Chuck Triano 212.733.3901. Source: Pfizer Inc.

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

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

Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease – Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)

Trending Sources

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

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

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 December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

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)

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

Bluebird Bio’s Skysona Receives FDA Approval and Becomes World’s Most Expensive Drug

New Rare Disease Drugs and Research Advancements

Spade SB-66

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

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

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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