Rethinking Clinical Trials

JULY 27, 2022

Vice Dean for Clinical Research. The key clinical questions of the ACTIV-6 study are: how to help someone feel better faster with newly diagnosed mild-moderate COVID-19 and how to prevent hospitalizations or death in someone with newly diagnosed mild-moderate COVID-19? We did not see as much diversity in this decentralized trial.

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Rethinking Clinical Trials

MAY 10, 2023

Participants have access to their information, data will be access broadly for research purposes, and security and privacy will be of highest importance. The Researcher Workbench is a cloud-based central resource with a passport access model. New researchers get $300 of free credits which will handle a lot of EHR access.

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Medicine Research Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. You can access the portal from desktop and phones.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

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Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

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Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Beyond privacy: A deeper understanding of the internet is required to protect digital trial participants. We need a new skill set or team member who studies cyber interaction, who can make sure your trial is safe. Eric Perakslis, PhD. Chief Science & Digital Officer. Andrea Downing.

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Clinical Research Research Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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Drugs FDA Approval Marketing Development 246

Pharmaceutical Technology

MAY 2, 2023

IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000. There is currently a rich and diverse IO pipeline that aims to address these unmet needs, with 703 IO products currently in clinical trials. Cost-related unmet needs also scored highly.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

pharmaphorum

JANUARY 9, 2023

Novartis’ programme providing free access to its spinal muscular atrophy (SMA) gene therapy Zolgensma is being scaled back to a dozen countries worldwide, according to the company. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1 Pause in UK access.

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Gene Therapy Genetics Gene Clinical Trials 119

XTalks

APRIL 18, 2024

Conversely, a negative result suggests a low probability of amyloid pathology, guiding healthcare providers in clinical decision-making and potentially ruling out Alzheimer’s disease in symptomatic patients. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease.

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Clinical Trials Clinical Trials In-Vitro Protein 52

Rethinking Clinical Trials

OCTOBER 26, 2023

There is now a cure for Hepatitis C, but many people are not able to access it. point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. Sharfstein, MD) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

AUGUST 18, 2022

The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials. The recruitment plan needs to include study materials that are tailored and accessible to the research population. Discussion Themes.

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Clinical Trials Clinical Trials Trials Insulin 130

Drug Discovery World

JANUARY 30, 2024

Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr Streamlining trial designs and regulatory pathways can help. Optimising these processes and exploring alternative delivery methods can bring down costs.

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Gene Therapy Manufacturing Gene Clinical Trials 71

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

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Gene Therapy Gene Engineer Production 147

Rethinking Clinical Trials

SEPTEMBER 21, 2023

SNAP Online Purchasing Pilot rapidly expanded during the pandemic with the goal of creating equitable access to online grocery shopping, leading to the growth of online grocery shopping sales among those with low incomes. I think we would need several different strategies all in combination to effect clinical outcomes.

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Clinical Trials Clinical Trials Sales Trials 130

XTalks

JULY 12, 2021

“Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval. This week, Rep.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

Rethinking Clinical Trials

AUGUST 10, 2023

This can be useful in the context of clinical trials. Today’s toughest health care problems could be easily gamified so that people can access technologies that allow them to ask and answer questions. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game?

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Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

SEPTEMBER 30, 2022

Randomized controlled trial. This trial took place in South Carolina at a time when Medicare was thinking about how to improve outcomes and if expanding home nursing services could improve health outcomes. The primary evaluation question for the trial was what is the impact of NFP on health outcomes when delivered at scale?

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Rethinking Clinical Trials

FEBRUARY 7, 2024

The spread of misinformation has accelerated, in part because more people than ever are accessing health information on the internet and via social media. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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The Pharma Data

DECEMBER 3, 2020

The manuscript describing the detailed results will be accessible on an online preprint server shortly. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

Radiology 111

Radiology Marketing Genome Genomics 111

pharmaphorum

OCTOBER 21, 2021

The company’s chief executive Michel Vounatsos said he was “obviously disappointed” with the result, which he maintained resulted mainly from a lack of clarity on reimbursement which has delayed patient access. Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

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Sales Doctors Doctor Gene Therapy 122

pharmaphorum

JUNE 8, 2021

That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” — Dr. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021.

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Drugs Marketing FDA Approval Trials 98

pharmaphorum

NOVEMBER 16, 2021

NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini group company Arvelle Pharma’s Ontozry. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

Drugs 98

Drugs Medicine Clinical Trials Clinical Trials 98

Intouch Solutions

APRIL 11, 2024

Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. However, in cases where such content is missing, it becomes necessary to grant access to a wide array of materials.

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Compliance Marketing Drugs Pharma Companies 52

The Pharma Data

JANUARY 31, 2021

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. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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Vaccination Vaccine Trials Protein 52

XTalks

AUGUST 23, 2021

This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Clinical Trials Clinical Trials Trials Drugs 52

pharmaphorum

MAY 10, 2022

As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of the readout of the confirmatory Clarity AD trial, due in the autumn.

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Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

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Big Data Medicine Marketing Clinical Trials 40

Rethinking Clinical Trials

FEBRUARY 22, 2023

It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?

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Clinical Trials Clinical Trials Trials Nurses 130

XTalks

FEBRUARY 27, 2024

Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial. Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments.

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Research Drugs Gene Therapy Clinical Trials 59

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Promising Clinical Results. Targeting HPV-Induced Head and Neck Cancer.

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Protein Engineer Immune Response In-Vivo 98

XTalks

AUGUST 19, 2022

XTALKS WEBINAR: How Agile Clinical Trials Unlock Universal Access to Rare Disease Research. Zynteglo’s hefty price tag of $2.8 Bluebird bio says it has the longest and most robust clinical program in transfusion-dependent beta?thalassemia Live and On-Demand: Tuesday, October 4, 2022, at 11am EDT (4pm BST/UK).

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Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Decentralized and Virtual Clinical Trials. million for a single infusion.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

JUNE 15, 2021

Can the biopharma industry step up again to shatter industry orthodoxy and create new pathways for innovation, access, and affordability? Payers anticipate diversification in contract models — opening the door for innovation in reimbursement and access. But there is a silver lining. Today’s economics demand it and it can be done. .

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Clinical Trials Clinical Trials Development Marketing 90

The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. With promising preliminary safety and immunogenicity results from the Phase 1 clinical study, Clover aims to quickly expand its current 2 x 2000L capacity of the Cytiva FlexFactory, which went into service in January 2020.

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Vaccination Vaccine Manufacturing Life Science 52