The Future is Now: Trends in Clinical Trials Brought to Reality

Crucial Data Soutions

A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The sponsor has chosen to take a hybrid approach to their study to decrease risk and increase patient safety, adhering to the FDA’s guidance on conducting clinical trials during the pandemic.

UK trial to assess Sativex for the treatment of ‘aggressive’ brain tumours

Pharma Times

Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD

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Predicting and improving clinical trial enrolment: A problem for psychiatry

Pharma Phorum

Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. Psychiatric disorders have historically had great difficulty onboarding and retaining patients for clinical trials.

Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials.

Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351 Variant Shared by Protein Vaccine Maker

XTalks

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. These results came from data from Novavax’s Phase III UK trial where B.1.117 is the dominant strain.

EU Clinical Trial Regulation: What, When, Who, Why, How?

CATO Research

The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review process for clinical trials via a centralized portal, is finally knocking at our doors.

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials. News Life Science News Pharmaceutical News Clinical Trial News COVID-19 Coverage Featured Oral Vaccine COVID-19 Vaccine Vaccine Clinical Trials

AZ resumes trial of COVID-19 vaccine

The Pharma Data

AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). The move follows a green light by the UK's MHRA.

AZ resumes UK coronavirus vaccine trial

Pharma Phorum

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. UK health secretary Matt Hancock welcomed the news in a tweet, saying it is “good news” that the trials are back up and running.

Calliditas Announces Full Enrollment of the Phase 3 NefIgArd Trial

The Pharma Data

The NefIgArd trial consists of two parts: Part A and Part B. Calliditas read out positive topline data from Part A of the trial on 8 November 2020 , announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR.

Syros Presents New Data From Phase 2 Clinical Trial of SY-1425 and Announces Plans to Initiate Registration-Enabling Trial in MDS and Randomized Phase 2 Trial in AML

The Pharma Data

The data that continue to emerge from the Phase 2 trial of SY-1425 are compelling,” said Stéphane De Botton, M.D., Head of Acute Myeloid Malignancies at Institut Gustave Roussy and a clinical investigator in the trial. CAMBRIDGE, Mass.–(BUSINESS

HR 52

Commencement of AAIC; GSK’s Shingles Vaccine Expanded Approval; Pfizer/ BioNtech Agreement with Biovac; Another Failure in Ulcerative Colitis Trial

Delveinsight

Remarkable drop was observed in altered filamin A plasma levels after treatment with simufilam in Phase 2b trials. a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials.

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus.

Hot Flash Clinical Trials at Riverside Clinical Research

Riverside Clinical Research

Hot flashes are commonly caused by certain foods and drinks – particularly spicy food, food or drinks containing caffeine and alcoholic beverages; medication side effects; stress; smoking; and even tight clothing.

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial

The Pharma Data

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine

The Pharma Data

No serious safety signals were raised in the trial. Analyses remain ongoing and NIAID and the INSIGHT Network intend to publish the full results of the trial soon. ” Following the outcome of the ITAC trial, the CoVIg-19 Plasma Alliance’s work now concludes.

Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is favourable for conducting clinical trials, and to encourage more sponsors to conduct trials across the European Union (EU) member states.

Positive Phase 1 results in high-dose setanaxib trial

The Pharma Data

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day. Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients. STOCKHOLM , Jan.

REMOTE Redux: DTP trials are still hard

Placebo Control

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting.

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).

Oncimmune partners with Genentech to profile samples from rheumatology trials

The Pharma Data

UK-headquartered company will characterise autoantibody profiles of clinical trial patients. Nottingham, UK-headquartered Oncimmune has signed a collaboration with Roche’s Genentech division to profile samples from the latter’s rheumatology clinical trials. Under this new project, Oncimmune will use its proprietary NavigAID panel to characterise the autoantibody profiles from trial participants.

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

An IND submission serves as a request to start clinical studies, containing a summary of information known about the drug, including nonclinical studies; chemistry, manufacturing and controls (CMC); and a proposed clinical plan.

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis

The Pharma Data

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo.

CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin for Phase 2 Clinical Trial

The Pharma Data

We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.” In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit.

Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

The Pharma Data

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.

Oxford University says participant illness that halted its COVID-19 trial may not be linked to the vaccine

The Pharma Data

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The American trials are still on a hiatus. . Photo by Retha Ferguson.

ASLAN Pharmaceuticals Opens Expansion Cohort in ASLAN004 Atopic Dermatitis Clinical Trial

The Pharma Data

Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. This release contains forward-looking statements.

Marinus Enrolls First Patient in Pivotal Phase 3 Clinical Trial of IV Ganaxolone in Refractory Status Epilepticus

The Pharma Data

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Within the RAISE trial, it will allow clinicians to rapidly establish a diagnosis of nonconvulsive SE in the absence of immediate availability of conventional EEG.

AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

Pharma Phorum

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Novavax’s COVID-19 Vaccine is Over 90 Percent Effective Overall, Including Against Variants

XTalks

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate.

Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate

The Pharma Data

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Using NCI controlled terminology for standardizing data

Pharma Phorum

The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC has partnered with the National Cancer Institute (NCI) to help bring consistency to terminology in clinical trials.

The Clinical Study Protocol: The Basics

Cloudbyz

3) Objectives & Purpose : This section contains a detailed description of primary and secondary objectives. Clinical Research CTMS Capture Clinical Trial Design Clinical Trial Management Cloudbyz Design Deviation Document Protocol Scientific Sponsors

PTC Therapeutics Announces Initiation of a Registration-Directed Clinical Trial to Evaluate Vatiquinone in Mitochondrial Epilepsy

The Pharma Data

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. .

Trial of 90-Year-Old Korean Church Leader Garners Nearly 30,000 Attendance Applications

The Pharma Data

GWACHEON, KOREA, November 02, 2020 /24-7PressRelease/ — The trial of Shincheonji Church of Jesus Chairman Man Hee Lee continued on October 21st as the court discussed the alleged violation of the Infectious Disease Prevention Act earlier this year.

Phase 1 Trial Evaluating Investigational Islatravir Subdermal Implant for the Prevention of HIV-1 Infection at CROI 2021

The Pharma Data

Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We

External control arms and debunking real-world data myths

Pharma Phorum

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. It is no surprise that total per patient costs exceed $100,000 in most oncology trials, with haematology patients costing multiples of that.

Novartis announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients with SMA

The Pharma Data

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Ad hoc announcement pursuant to Art. 53 LR.

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet

The Pharma Data

The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.

AMRI Signs Supply Agreement with AstraZeneca to Manufacture COVID-19 Vaccine

XTalks

AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine can help prevent symptomatic coronavirus disease from spreading. The genetic material contains SARS-CoV-2 spike protein.

GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer

XTalks

Confirmatory trial(s) to verify and specifically describe clinical benefit may be needed in the future for continued approval for this indication. Dostarlimab and the GARNET Trial.