Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. The potential Phase II trial in Parkinson’s disease will recruit between 75 and 100 patients, said Kelleher-Andersson.

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Clinical Trial Podcast

AUGUST 31, 2022

Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients. Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges. appeared first on Clinical Trial Podcast & Blog.

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XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants. ”

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Scienmag

NOVEMBER 16, 2020

A Rutgers study finds nurses have the highest prevalence of infection Health care workers — particularly nurses — have a higher prevalence of SARS-CoV-2 infection than non-health care workers, according to researchers at Rutgers, which released baseline results from a large prospective study of participants at Rutgers and affiliated hospitals (..)

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ACRP blog

JANUARY 5, 2023

and Canada) has developed a variety of early talent programs. We’re putting in place entry-level programs to attract, develop, and retain diverse early talent,” says Kim Jochman, PhD, RAC, Senior Director, Medical Writing, at Merck. The recruitment process for these positions is highly competitive.

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Worldwide Clinical Trials

FEBRUARY 26, 2024

It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval. The competition, paired with recruitment challenges due to the COVID-19 pandemic, led to complex operational challenges.

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Drug Discovery World

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. Now, the first patients have been enrolled in CALYX Phase III. Minoryx has begun an extensive pre-screening program aimed at identifying additional eligible patients.

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Drug Discovery World

FEBRUARY 28, 2023

Dr Asma Patel , Vice President of Integrated Services for Early Development at Quotient Sciences, reflects on the biggest barriers to rare disease drug development and how companies can overcome these. Understanding complexity in supply chain for rare diseases, i.e. slow and sporadic patient recruitment and thus protracted clinical studies.

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XTalks

MAY 19, 2023

Of the total registered studies, 64,838 are actively recruiting participants. This represents a significant increase from the over 365,000 registered trials reported in early 2021. Percentage of Trials Completed The completion rates for all clinical trials from Phase I to Phase IV were estimated to be around 91.4

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Drug Discovery World

JULY 31, 2023

Promontory Therapeutics has treated its first patients in France as part of the ongoing Phase II clinical trial of PT-112 in patients with late-stage metastatic castration-resistant prostate cancer (mCRPC).

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Pharmaceutical Technology

JUNE 15, 2023

Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. Clinical trials are divided into phases evaluating drug safety, side effects and effectiveness from increasingly larger pools of candidates and patients. Food and Drug Administration approval.

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Advarra

MARCH 10, 2023

The sickle cells die early, which causes a constant shortage of red blood cells.” SCD is defined as a rare disease, a disease affecting fewer than 200,000 people in the United States. VOEs are multifactorial and may stem from a variety of causes, and a high rate of VOEs is typically associated with early mortality from multi-organ damage.

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Drug Discovery World

SEPTEMBER 2, 2022

Scientists from Tokyo University of Science have shed light on how various molecules are recruited in endocytosis, a cellular process of bringing in different types of materials from the outside. Until now, the recruitment processes of the molecular players to the site and the switch between the early and late phases were not well understood.

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pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

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Cloudbyz

APRIL 9, 2023

Here are some best practices to accelerate clinical site activation: Early planning: Initiate the site activation process early in the clinical trial design phase to identify potential bottlenecks and implement preventive measures. Well-trained staff will be more efficient and help minimize protocol deviations and data errors.

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pharmaphorum

NOVEMBER 19, 2021

And it recently recruited Arcus’ chief medical officer Bill Grossman to head up its oncology programme, further cementing the alliance. Domvanalimab is the furthest along in development of the partnered drugs, as it is currently in phase 2 and 3 studies in non-small cell lung cancer (NSCLC), while AB308 is in phase 1 testing.

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Drug Discovery World

APRIL 18, 2024

Human challenge models have contributed significantly to the development of vaccines for diseases such as malaria or typhoid, especially in early phase trials. Healthy people who had never had the BCG vaccine before were recruited into the trial. The dose given was gradually increased to ensure it was safe.

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pharmaphorum

NOVEMBER 4, 2022

“Lykke brings more than 20 years of pharmaceutical experience, ranging from early-stage drug development to post-approval lifecycle management,” said Boehringer in a statement. The post Boehringer recruits former Novartis’ neurosciences head as its CMO appeared first on.

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pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. How they could facilitate clinical engagement with late-phase research.

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pharmaphorum

OCTOBER 8, 2020

As of 9th September, data from the NIHR Clinical Research Network has shown that 45% of non-COVID studies are open to recruitment and 36% of those have been recruiting since June. The UK led the rest of Europe in the number of early phase 1 and phase 2 clinical trials.

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pharmaphorum

OCTOBER 26, 2020

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. Studies have suggested that that black and minority ethic people are at higher risk of dying from COVID-19 than the rest of the population.

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pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. It will recruit people with osteoarthritis who have exhausted other treatment options but are still experiencing moderate to severe pain.

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pharmaphorum

AUGUST 16, 2021

The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results are positive. By day five, none of the molnupiravir-treated patients showed evidence of the virus, compared with 24% of those on placebo.

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Cloudbyz

FEBRUARY 3, 2021

Because of their criticality, the success of clinical trials is hugely dependent on patient recruitment and retention. Data reveals that 85% of clinical trials fail to recruit enough clinical trial volunteers, while 80% of these clinical trials fail execution within the allotted time. Let’s take a more in-depth look.

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Delveinsight

JULY 29, 2021

The deal adds TNB-585, a phase 1 bispecific T cell-engager zeroed in at metastatic castrate-resistant prostate cancer (mCRPC) , and several preclinical oncology pipeline assets with the potential for near-term IND filings. . The biopharma is putting USD 900 million down upfront, with USD 1.6

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Worldwide Clinical Trials

JUNE 15, 2022

Early engagement and discussions can help you prevent the risk of a clinical hold. We are closely tracking our sites’ situations in order to recommend and plan accordingly for successful recruitment. Being realistic about which sites can support your study and which sites may struggle is a necessary part of successful recruitment.

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pharmaphorum

OCTOBER 28, 2022

Identifying, reconciling, and incorporating the often-competing needs of the various stakeholders as early as possible in the product development cycle is a highly effective risk reduction strategy. start reconciling competing audience needs early in the process. start reconciling competing audience needs early in the process.

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pharmaphorum

MARCH 23, 2021

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . The study completed recruitment earlier this year, with 791 patients across around 100 sites signing up globally.

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The Pharma Data

OCTOBER 29, 2020

Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe. on clinical trial costs, throughout all study phases, across both regions. on clinical trial costs, throughout all study phases, across both regions. “We

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pharmaphorum

MARCH 14, 2022

The phase 2 AMEERA-3 trial was testing amcenestrant in women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast cancer, and showed no benefit in progression-free survival for the drug compared to physician’s choice endocrine therapy.

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Drug Discovery World

JANUARY 24, 2023

In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3. He says: “To start, manufacturers need to be making more informed business decisions not only at the point of commercialisation but also during the clinical phases. So where to start? Let’s take clinical trials, for example.

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Drug Discovery World

OCTOBER 6, 2022

protofibril antibody lecanemab met the primary endpoint and all key secondary endpoints in the global Phase III Clarity AD clinical trial. . The recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the US. Eisai and Biogen’s anti-amyloid beta (A?)

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Early impact of the war.

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pharmaphorum

MAY 6, 2021

“We are targeting a treatment that has the potential to be effective at the early phase of infection, to minimise the risk of hospitalisation and reduce the need for ventilatory support in intensive care.” “Seasonality will play a role, with winter being the ideal time to recruit patients,” said McGoldrick.

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pharmaphorum

AUGUST 17, 2022

The decision to abandon development of the oral selective oestrogen receptor degrader (SERD) comes after an interim analysis of the phase 3 AMEERA-5 trial failed an interim analysis.

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pharmaphorum

NOVEMBER 11, 2022

IQVIA’s research has been helped by a “dramatic increase” in diversity data collection in phase 2 and 3 trials in the past six years, which has provided a baseline against which progress can be gauged. While the data for 2021 isn’t complete, early signs are that it has fallen further to 6%. for Hispanics.

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pharmaphorum

DECEMBER 20, 2021

That hope now look decidedly faint, as ligelizumab was able to match Xolair (omalizumab) but not improve on it in a pair of phase 3 trials in CSU, although it did perform better than placebo. ” Remibrutinib recently started phase 3 testing.

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