Rethinking Clinical Trials

MARCH 27, 2024

Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.”

Trials 161

Trials Clinical Trials Clinical Trials Medicine 161

Rethinking Clinical Trials

DECEMBER 13, 2023

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward." Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Join the online meeting.

Clinical Trials 169

Clinical Trials Clinical Trials Trials Medicine 169

Pharmaceutical Technology

MARCH 27, 2023

Regenerative medicines in early-stage development (preclinical, discovery, or investigational new drug [IND]/ clinical trial application [CTA] filed status) have seen a change in drug targets compared to therapies in late-stage development (Phase II to pre-registration stage).

Medicine 246

Medicine Gene Therapy Gene Dermatology 246

pharmaphorum

JANUARY 17, 2023

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool.

Clinical Trials 98

Clinical Trials Clinical Trials Medicine Trials 98

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

FDA Approval 246

FDA Approval Medicine Trials Drugs 246

Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. Reduces Trial Failures Oftentimes, clinical trials may fail due to a lack of efficacy.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Pharmaceutical Technology

NOVEMBER 21, 2023

The new scheme will launch in 2024 and aims to save the National Health Service (NHS) £14bn over five years.

Clinical Trials 246

Clinical Trials Clinical Trials Medicine Trials 246

Rethinking Clinical Trials

APRIL 4, 2024

The results of the study were published this week in the New England Journal of Medicine. ICD-Pieces, an NIH Collaboratory Trial , was a cluster randomized, pragmatic clinical trial testing an intervention that used an electronic health record–based algorithm and practice facilitators in 141 primary care practices. .

Trials 161

Trials Clinical Trials Clinical Trials Medicine 161

Pharmaceutical Technology

OCTOBER 25, 2023

A blockchain system intended to ensure the safety and authenticity of medicines across the supply chain could change the way that medical professionals work, as discussed at the 11th Annual Clinical Trial Supply Nordics conference.

Medicine 130

Medicine Clinical Trials Clinical Trials Trials 130

Rethinking Clinical Trials

FEBRUARY 21, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Bioinformatics 130

Outsourcing Pharma

MARCH 11, 2024

On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinical trial, dubbed CANPAIN.

Medicine 124

Medicine Clinical Trials Clinical Trials Trials 124

Rethinking Clinical Trials

MARCH 13, 2024

Edward Qian In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial." The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults. Join the online meeting.

Trials 177

Trials Clinical Trials Clinical Trials Medicine 177

Rethinking Clinical Trials

FEBRUARY 14, 2024

Jeffrey Carson In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.” Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard C.

Trials 152

Trials Clinical Trials Clinical Trials Medicine 152

Rethinking Clinical Trials

MARCH 6, 2024

Schell Professor of Management and Applied Economics MIT Sloan School of Management Slides Keywords Food-as-Medicine, Randomized Clinical Trial, Diabetes Key Points Diabetes is common and costly. Food-as-Medicine observational studies have had a large correlation with improved health. 9% of the U.S.

Clinical Trials 141

Clinical Trials Clinical Trials Medicine Trials 141

Rethinking Clinical Trials

JANUARY 22, 2024

What happens to a pragmatic trial intervention after the study ends? The article was published online ahead of print this month in the Journal of General Internal Medicine. The case studies in the article are from the ABATE Infection, LIRE, PPACT, PROVEN, STOP-CRC, and TSOS trials. Learn more about the NIH Collaboratory Trials.

Trials 152

Trials Clinical Trials Clinical Trials Medicine 152

Rethinking Clinical Trials

FEBRUARY 19, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.

Trials 130

Trials Bioinformatics Clinical Trials Clinical Trials 130

BioPharma Reporter

NOVEMBER 22, 2022

GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.

Trials 145

Trials Medicine Development 145

Rethinking Clinical Trials

AUGUST 9, 2023

The Stepped Wedge Cluster Randomized Trial: Friend or Foe? Description Dr. Monica Taljaard and Dr. David Magnus discuss the pros and cons of the stepped wedge cluster randomized trial. appeared first on Rethinking Clinical Trials.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 8, 2024

The Drugs Technical Advisory Board (DTAB) has suggested to the ministry of health and family welfare (MoHFW) to write to the ministry of corporate affairs to mandate the pharma companies to spend almost one per cent of their net profit for providing free medicines in medicine banks as part of the Corporate Social Responsibility (CSR). […]

Medicine 137

Medicine Pharma Companies Drugs Clinical Trials 137

Pharmaceutical Technology

FEBRUARY 27, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorisation for Me rck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir).

Medicine 162

Medicine Regulation Trials Production 162

pharmaphorum

APRIL 30, 2024

Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot therapies for a range of severe genetic diseases.

Genetic Disease 105

Genetic Disease Trials Genetics Medicine 105

Drug Discovery World

MAY 17, 2023

Leveraging historical trial databases has become commonplace in assessing the feasibility of trials in therapeutic areas with a large breadth of clinical development history. EHR data also has a key role to play in designing future clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

Bio Pharma Dive

MARCH 7, 2024

Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.

Trials 287

Trials Medicine Drugs 287

Bio Pharma Dive

MARCH 3, 2022

As Aduhelm sputters on the market, Roche aims to prove its experimental medicine can work better. A large, multi-year trial is part of that bet.

Trials 304

Trials Medicine Drugs Marketing 304

Rethinking Clinical Trials

OCTOBER 22, 2023

What Are Pragmatic Clinical Trials? Description In this video, Dr. Lesley Curtis describes pragmatic clinical trials. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related Why Should I Do A Pragmatic Trial?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Research 130

Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

RNA 287

RNA Medicine Clinical Trials Clinical Trials 287

Pharmaceutical Technology

AUGUST 11, 2022

Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US. To back the merger, Disc raised funds worth $53.5m

Medicine 147

Medicine Clinical Trials Clinical Trials Licensing 147

Rethinking Clinical Trials

AUGUST 9, 2023

Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials Description Dr. Emily Largent discusses ethical considerations when vulnerable populations are subjects in pragmatic trials. Biography Emily A.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

JUNE 20, 2023

The Department of Health Abu Dhabi (DoH) has signed a memorandum of understanding with integrated healthcare company M42 and AbbVie Biopharmaceuticals to advance personalised medicine and genomics in the city. M42 was created through the combination of Mubadala Health and G42 Healthcare.

Medicine 130

Medicine Genome Genomics Clinical Trials 130

Rethinking Clinical Trials

APRIL 19, 2023

In this Friday’s PCT Grand Rounds, Amit Garg of Western University’s Schulich School of Medicine & Dentistry will present “Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-Randomised Trial.” Join the online meeting.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

OCTOBER 22, 2023

Why Should I Do A Pragmatic Trial? Description Dr. Lesley Curtis discusses reasons to conduct pragmatic clinical trials. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related What Are Pragmatic Clinical Trials?

Trials 130

Trials Clinical Trials Clinical Trials Clinical Research 130

Rethinking Clinical Trials

AUGUST 9, 2023

Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials Description Joseph Ali, Tanya Matthews, and Leslie J. Crofford discuss responding (or not) to signals of potential clinical significance in pragmatic clinical trials. Biography Joseph Ali, JD Assistant Professor, Dept.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

JULY 6, 2023

Michele Balas and Dr. Eduard Vasilevskis The NIH Pragmatic Trials Collaboratory is excited to add 2 new Demonstration Projects to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems.

Trials 246

Trials Nurses Medicine Clinical Trials 246

JAMA Internal Medicine

DECEMBER 25, 2023

This randomized clinical trial examines whether an intensive food-as-medicine program can improve glycemic control and ,1rengagement with preventive health care compared with usual care among adults with diabetes and food insecurity.

Medicine 108

Medicine Clinical Trials Clinical Trials Trials 108

Outsourcing Pharma

DECEMBER 15, 2021

The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

Trials 141

Trials Medicine Drugs Clinical Development 141

Bio Pharma Dive

DECEMBER 4, 2023

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

Drug Trials 259

Drug Trials Trials Medicine Drugs 259

Rethinking Clinical Trials

MAY 31, 2023

John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” ” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. Join the online meeting.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130