Pharmaceutical Technology

JANUARY 3, 2024

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

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Rethinking Clinical Trials

JANUARY 8, 2024

In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them.

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Trials Clinical Trials Clinical Trials Research 298

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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Rethinking Clinical Trials

JULY 23, 2024

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Learn more about the Ethics and Regulatory Core.

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 5, 2024

India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.

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Clinical Trials Clinical Trials Trials Drugs 183

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

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Rethinking Clinical Trials

DECEMBER 5, 2023

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. There will be an emphasis on experiential learning for future trial leaders and postdoctoral fellows in the program through the development of a pragmatic trial protocol.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Researchers analyzed the electronic health records of more than 18,000 US patients between May 2022 and September 2023 to compare outcomes among those receiving the two injected medicines, and published the […]

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Clinical Trials Clinical Trials Drugs Trials 229

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

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Rethinking Clinical Trials

DECEMBER 3, 2024

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. The article was published online ahead of print in Clinical Trials.

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Trials Clinical Trials Clinical Trials Research 124

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 29, 2024

The Union health ministry has issued final notification defining the clinical research organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September […]

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Bio Pharma Dive

NOVEMBER 22, 2024

Despite plans to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy giant remains committed to aiding drug research.

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Rethinking Clinical Trials

NOVEMBER 25, 2024

Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems.

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Trials Clinical Trials Clinical Trials Research 147

Rethinking Clinical Trials

AUGUST 29, 2024

A virtual, asynchronous learning program that offers open-access modules to anyone interested in learning about the complex art of pragmatic clinical trial design and implementation is now available. More than 75 learners from across Canada have been admitted to this pan-Canadian program after a competitive selection process.

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Trials Clinical Trials Clinical Trials Research 189

Rethinking Clinical Trials

OCTOBER 3, 2024

In a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work. View the full workshop materials.

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Clinical Trials Clinical Trials Research Trials 195

Bio Pharma Dive

OCTOBER 1, 2024

Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies' research progress. Here’s a list of conferences to watch in 2025.

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Bio Pharma Dive

OCTOBER 14, 2024

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

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Rethinking Clinical Trials

SEPTEMBER 24, 2024

In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. Learn more about the GRACE trial.

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Clinical Trials Clinical Trials Trials Medicine 270

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs? To learn more about our end-to-end services, contact us today.

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Rethinking Clinical Trials

MARCH 28, 2024

Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.

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Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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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.

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Worldwide Clinical Trials

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success. Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. A promising new medicine has now […]

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Clinical Trials Clinical Trials Protein Scientist 245

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. While lockdown measures continued for most of the year in China, specialised CAR-T research continued to advance faster in the country than elsewhere. Tracking the news.

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Clinical Trials Clinical Trials Trials Vaccination 306

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 20, 2024

The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.

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Rethinking Clinical Trials

DECEMBER 18, 2024

The research team looked at the comparative effectiveness of HBPTM alone versus HBPTM plus telephone-based NCM when administered to Black and Hispanic stroke survivors with uncontrolled hypertension. The research team found that both groups experienced significant SBP reduction at both the six-month and 12-month mark.

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Rethinking Clinical Trials

DECEMBER 17, 2024

December 8, 2024 : The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. O'Brien, PhD Session 1: What Are Embedded Pragmatic Clinical Trials? Morain, PhD, MPH *This session includes case study presentations.

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Rethinking Clinical Trials

DECEMBER 5, 2024

Sheana Bull, principal investigators for Nudge Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Learn more about Nudge.

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Rethinking Clinical Trials

OCTOBER 22, 2024

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. ” The annual conference is cohosted by the NIH and AcademyHealth. ” The annual conference is cohosted by the NIH and AcademyHealth.

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Trials Clinical Trials Clinical Trials Research 162

Rethinking Clinical Trials

NOVEMBER 20, 2024

Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” ” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern.

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Trials Clinical Trials Clinical Trials Research 173

Rethinking Clinical Trials

SEPTEMBER 16, 2024

Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. Learn more about the NIH Collaboratory Trials.

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Research Clinical Trials Clinical Trials Trials 162

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 22, 2024

The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.

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