Worldwide Clinical Trials

NOVEMBER 10, 2023

At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomarkers, and others. As mentioned, these are but a few topics for contemplation.

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Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues.

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ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

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STAT News

MARCH 16, 2023

But for most medical devices, placebo trials have never been done. The most basic argument for this, put forth by medical device makers and regulators, is that mimicking an invasive procedure is far more difficult than handing patients a sugar pill.

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Find Me Cure

APRIL 16, 2020

With 85% of patients unaware of clinical trials as an option at the time of their diagnosis, according to the NIH , it’s a shame that many parts of the application process are still needlessly complicated when a patient is aware and motivated. How to search for relevant trials. What if there are no trials near you.

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ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

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pharmaphorum

SEPTEMBER 28, 2022

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. Trial sponsors are still left with the challenge of including children in an ethical , safe, and secure way, and the new guidance is the FDA’s attempt to make that easier to achieve.

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Outsourcing Pharma

JANUARY 16, 2023

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

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Drug Trials Doctors Doctor Drugs 59

Advarra

NOVEMBER 17, 2022

Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Usually, when there aren’t data to support enrolling children in clinical trials, the risk threshold requires the prospect of direct clinical benefit. Why This Guidance Now? Pediatric studies are necessary.

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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pharmaphorum

MAY 14, 2021

But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial. Reuters quoted Kintor’s chief financial officer Lucy Lu, who said that Kayali was one of its trial investigators.

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FDA Law Blog

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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pharmaphorum

DECEMBER 24, 2020

BMS said an independent committee had reviewed data from the phase 3 CheckMate-548 trial in newly diagnosed MGMT-methylated glioblastoma multiforme and concluded that it would be unlikely to meet its primary overall survival (OS) goal. The post BMS calls time on brain cancer trial as Opdivo misses second target appeared first on.

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XTalks

JUNE 14, 2023

It can compile the information and provide an analysis, which can alert patients and offer advice to doctors for improving care. Now, our partners can launch Class II regulated software for new diseases and use cases in a matter of weeks on our platform, rather than the years they may have taken to develop and regulate their own solution.

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Worldwide Clinical Trials

FEBRUARY 22, 2023

Panelists will answer questions such as: What are the greatest challenges holding patients back from enrolling in trials? At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

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The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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XTalks

FEBRUARY 22, 2021

Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. A clinical research coordinator works under the principal investigator’s direction, which is a person responsible for designing, conducting and managing clinical trials.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. The reason why the project management role is so interesting is because it provides a holistic view of clinical trial management and clinical research. They are accountable of all aspects of a clinical trial.

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pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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pharmaphorum

NOVEMBER 3, 2020

The reason why competition regulators were concerned about Otezla was BMS’ deucravacitinib, which was in Bristol’s pipeline when the $74 billion merger was being finalised last year. BMS said deucravacitinib also beat Otezla on the 75% skin clearance score and the global doctors’ assessment.

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pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. In the phase 1 part of the trial, participants received one component of the two-part vaccine.

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Find Me Cure

SEPTEMBER 2, 2020

This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. . Today let’s take a look at some of the barriers to trial participation and the issues that break the trust patients have in research. .

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The Pharma Data

JANUARY 17, 2021

The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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pharmaphorum

JANUARY 6, 2021

Analysts are continuing to back Inventiva’s lanifibranor as a potential “best-in-class” drug for the fatty liver disease NASH, as the company prepares for the launch of a phase 3 trial in spring. The trial will take a while however, with results not due until the second half of 2023, with sales forecast to peak at around $2.6

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pharmaphorum

AUGUST 18, 2020

The regulator has granted a faster six-month Priority Review for the fixed dose regimen, based on data from several Imfinzi clinical trials, including results from the phase III CASPIAN trial in extensive stage small-cell lung cancer (ES-SCLC) which used the four-week, fixed-dose regimen during maintenance.

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pharmaphorum

NOVEMBER 1, 2021

Like most heavily regulated industries, pharma is very process driven, but patient centricity requires the focus to be on outcomes, rather than tasks. “We One example of patient centricity in action at Boehringer Ingelheim is how the company has changed its clinical trial communications policies, she said. We were very proud of it.

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pharmaphorum

FEBRUARY 5, 2021

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. It also says patients should not stop taking Xeljanz without consulting with their physician first.

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pharmaphorum

JANUARY 7, 2021

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

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Drug Discovery World

OCTOBER 18, 2023

4 Unfortunately, many AAV-based gene therapies fail during clinical trials, despite them appearing safe and efficacious in preclinical studies. For example, researchers may find that an AAV vector-based gene therapy displays excellent transduction efficiency in a preclinical model, only to see the efficiency drop in clinical trials.

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FDA Law Blog

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. Given the broad range of products regulated by FDA, the laundry list of activities prohibited under the FDC Act, and the scope of strict liability misdemeanor exposure, we respectfully disagree.

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pharmaphorum

SEPTEMBER 9, 2020

Merck & Co is planning to file a drug for unexplained or treatment-resistant cough after supportive results from two phase 3 trials. US-based Merck , known as MSD outside the US and Canada, said results from the phase 3 COUGH-1 and COUGH-2 trials will form the basis of filings with regulators across the world.

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pharmaphorum

SEPTEMBER 24, 2020

An artificial intelligence-powered diagnostic for autism spectrum disorder (ASD), developed by Cognoa, has met all its objectives in a pivotal trial and will be filed for approval with the FDA. Cognoa has revealed however that the trial suggests the app is highly accurate across males and females as well as ethnic and racial backgrounds.

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STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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pharmaphorum

FEBRUARY 4, 2021

Several vertical projects should address specific issues, such as the creation of a national observatory of digital medicine and decentralised clinical trials. There needs to be more interest from innovative companies and research and clinical trials to ensure DTx have credibility with doctors and clinicians, he added. “At

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XTalks

NOVEMBER 16, 2020

This is according to preliminary trial data from the company’s ongoing study that involves 30,000 people in the US. The news comes shortly after Pfizer and BioNTech’s mega announcement last week of their COVID-19 vaccine having shown 90 percent efficacy in an ongoing large-scale Phase III trial. percent effective.

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