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. It was data that was sitting there without alerts in our system.

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Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.

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Pharmaceutical Technology

DECEMBER 15, 2022

This extrapolation leverages data from GlobalData’s World Markets Healthcare and PharmOnline International databases to expand the number of markets in GlobalData’s patient-based sales forecast model from seven major markets (7MM) to 68 markets (68M). of sales in 2021 and 2031 respectively. of global cardiomyopathies sales in 2021 and 31.2%

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Rethinking Clinical Trials

DECEMBER 20, 2023

It is important to note when you look at the ARIC surveillance data, there is consistently higher risk in black females and males across all ages. Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. We have to change how we are practicing.

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Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. It collates and synthesizes foundational resources to create a unified, comprehensive resource.

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Roots Analysis

JANUARY 28, 2024

Big Data in healthcare refers to the vast amount of data that is continuously expanding and cannot be efficiently stored or processed using traditional tools. Within the healthcare sector, structured data includes demographic details, vital indicators (like, height, weight, blood pressure, blood glucose).

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Rethinking Clinical Trials

JULY 9, 2023

Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design.

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Clinical Trials Clinical Trials Trials Research 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. The E6 Good Clinical Practice clinical trial conduct principles was intended to be an improvement of the G8 clinical trial design principles.

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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. The E6 Good Clinical Practice clinical trial conduct principles was intended to be an improvement of the G8 clinical trial design principles.

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Pharmaceutical Technology

MAY 2, 2023

Combining data from all markets, efficacy-related needs were identified as the most important unmet needs category. 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. Cost-related unmet needs also scored highly.

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Rethinking Clinical Trials

OCTOBER 26, 2023

There are possible clinical research components that would include research on treatment during pregnancy, vaccine development, and implementation model research. PCORnet is engaging with sites to support the ITAP clinical study for de novo clearance of a qualitative POC HCV test-to-treat platform. A manuscript is under development.

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Clinical Research Clinical Trials Clinical Trials Research 143

XTalks

JUNE 28, 2023

Options for managing the symptoms of DMD have been limited. It said the clinical studies didn’t provide “unambiguous evidence” that the treatment is “likely beneficial” for the patient pool, which included older children such as those six and seven years of age. million price tag of Elevidys, a one-time gene therapy.

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Gene Therapy Gene Protein FDA Approval 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. Pharmacovigilance : Early identification of adverse drug reactions, higher data integrity and faster response times.

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pharmaphorum

JANUARY 24, 2022

A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. For its part, IBM has said that the Watson for Oncology product has been improving year-on-year as the AI crunches more and more data.

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Radiology Marketing Genome Genomics 111

pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

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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

Rethinking Clinical Trials

SEPTEMBER 13, 2023

After enrolling patients for 8 months, the data safety board recommended trial enrollment stop because the prespecified stopping criteria for efficacy had been met. Nearly 2,000 patients were assessed for eligibility and 1,417 patients were enrolled. For late career expert operators results of our trail may not apply.

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The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Effectiveness of current treatments : Corticosteroids and IL6 Receptor Blockers will still be effective for managing patients with severe COVID-19. On 26 November 2021, WHO designated the variant B.1.1.529

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pharmaphorum

DECEMBER 23, 2022

Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers. Oral therapy data presented at ASH. Side effects and cost implications. CellCentric, a U.K-based

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Development Drugs Clinical Development Antibody 52

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 Joel Eichmann, Co-Founder and Managing Director, Green Elephant Biotech, agrees that prices need to come down significantly for CGT to be widely available.

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Gene Therapy Manufacturing Gene Clinical Trials 71

pharmaphorum

NOVEMBER 16, 2021

. “The FAD is a significant milestone for cenobamate and takes us closer towards reimbursement in England and Wales,” commented Stuart Mulheron, general manager UK & Ireland, Angelini Pharma. 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.

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Drugs Medicine Clinical Trials Clinical Trials 92

XTalks

OCTOBER 12, 2022

Magnetic resonance imaging (MRI) has had a part in clinical trials for more than three decades now. However, the role of MRI in new drug clinical trials can involve diagnosis of lesions and determination of their severity, early identification of therapeutic responders to drug treatment and treatment monitoring and follow-up.

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Clinical Trials Clinical Trials Trials Drugs 93

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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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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The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

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XTalks

JUNE 8, 2021

In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease. Prior to Zolgensma, treatments could only help manage symptoms and attempt to improve quality of life. With a price tag of over $2.5 Zolgensma Gene Therapy: START Trial.

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Gene Therapy Gene Protein Trials 110

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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Rethinking Clinical Trials

OCTOBER 19, 2022

Trials are getting larger and collecting greater volumes of clinical data than ever before, often as part of Common Data Elements (CDEs). These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. Vanderbilt University Medical Center. Key Points.

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Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite this, the Institute for Clinical and Economic Review (ICER) claimed that a fairer price would be in the region of $2.9m.

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Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

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Clinical Trials Clinical Trials Trials Research 130

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them.

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Compliance Life Science Marketing Production 52

pharmaphorum

OCTOBER 4, 2022

Central to the initiative is the aim to gather data from willing participants that can provide greater insights into cancer development and treatment over time. The Moonshot was started with three aims: to accelerate scientific discovery in cancer, foster greater collaboration between stakeholders, and to improve the sharing of cancer data.

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pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. And governments struggle to manage costs.

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. Wegovy had a price tag of $1,297 a month when it was first launched.

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Drug Discovery World

NOVEMBER 13, 2023

Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET, on: ‘The singular immune response to dengue and machine learning identification of antibodies in high-throughput sequences’.

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Protein Antibody Engineer Scientist 59

XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. Anderson, PharmD, PhD, Radiation Clinical Pharmacologist, A.

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Drug Discovery World

NOVEMBER 9, 2023

This session will conclude with a plenary keynote session, introduced by Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET.

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