Rethinking Clinical Trials

JANUARY 31, 2024

The second key decision point is development and adaptation, which is either building or adapting an external solution for internal clinical use. The next key decision point is clinical integration. – How do you get reliable information and data for care that is received outside of Duke?

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Rethinking Clinical Trials

MARCH 6, 2024

Schell Professor of Management and Applied Economics MIT Sloan School of Management Slides Keywords Food-as-Medicine, Randomized Clinical Trial, Diabetes Key Points Diabetes is common and costly. Clinic staff included a dietitian, a nurse and a community health worker.              Speaker Joseph Doyle, PhD Erwin H.

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Rethinking Clinical Trials

APRIL 18, 2023

This broad set of clinical conditions and varied underlying causes underscore the need for testing a broad portfolio of therapeutic agents. We have people with experience with post-viral symptoms, treating ME/CFS, general COVID knowledge, biomarker experience, clinical trials, patient-reported outcomes, and more.

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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

JUNE 29, 2022

Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. Big Data, a term first used in the 1990s, leverages modern technology to increase the quantity, forms, speed, and capability to manipulate large-scale data. Food and Drug Administration (FDA). Key Points. Discussion Themes.

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Rethinking Clinical Trials

MARCH 28, 2023

It is an independent, nonprofit, research institute and leading funder of patient-centered comparative clinical effectiveness research (CER). It has grown to be a major force for supporting pragmatic research, both real-world evidence research and supporting observational research and pragmatic clinical trials. enabled research.

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Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Additionally, both the companies will share CTH-004 pre-clinical and clinical data in future.

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Rethinking Clinical Trials

JANUARY 17, 2024

UPMC did not allow patients to receive experimental COVID-19 therapies outside of the context of a clinical trial and used the REMAP-CAP platform, a global pragmatic adaptive trial platform, in all clinic sites. UPMC set clear criteria based on the published data at the time for who could and could not receive Remdesivir.

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Rethinking Clinical Trials

JANUARY 26, 2023

This study is looking at a particular subpopulation, where there is a lack of outcomes data. Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. – Could you talk a little bit more about hybrid data collection?

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Pharmaceutical Technology

NOVEMBER 9, 2022

On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies. million price tag. The post Can gene therapies for haemophilia defend their high price tags? million ($1.8 million at the time).

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Gene Therapy Gene FDA Approval Medicine 278

pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. In a statement, Biogen and Eisai said that the FDA has agreed that Clarity AD “can serve as the confirmatory study to verify the clinical benefit of lecanemab.”

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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 need to think about removing some of this and evaluate.

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Rethinking Clinical Trials

SEPTEMBER 28, 2023

The trial was cluster randomized by clinic for usual care or intervention arms; participants were parents with infants 12 months and younger. The first year was spent allowing the clinics to make the project their own, with input from parents and clinicians. Learn more Read more about PARENT in JAMA.

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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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Rethinking Clinical Trials

OCTOBER 4, 2022

Senior Director Clinical Trial Operations. Neurological Clinical Research Institute. Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints. Marianne Chase. Massachusetts General Hospital. Jörg Goldhahn, MD. Medical Director. ETH Zurich.

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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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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

AUGUST 30, 2023

To try to bridge the gap between PRO collection and meaningful use during clinical encounters, the RA PRO dashboard was developed. The hypothesis was that the RA PRO dashboard used during clinical encounters will increase patient engagement, foster shared decision making, and improve health outcomes for patients with RA.

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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. All of Us has a philosophy to get data to researchers quickly. The Research Workbench data browser is available with no log in and you get aggregate results.

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Rethinking Clinical Trials

OCTOBER 11, 2023

Through this initiative, 7 Clinical Centers are expected to test an evidence-based, multi-level intervention designed to reduce or eliminate cardiovascular and/or pulmonary health disparities. They also helped review each Clinical Center’s protocol before it went to the DSMB and NHLBI for transition to the UH3 phase.

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Rethinking Clinical Trials

MARCH 1, 2023

To reduce the burden on sites, the study has simplified data reporting by reducing time points data, reducing the number of forms that need to be submitted, and reducing the number of data elements within a form. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

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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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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 10, 2023

” The key to quality of AI and utilizing AI in a beneficial way relates to the quality of the data. It’s important for organizations to recognize this and upgrade their data in order to these technologies more effectively and efficiently. This can be useful in the context of clinical trials.

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Rethinking Clinical Trials

JULY 22, 2022

There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical. Candidate agents were triaged based on concurrent clinical trials, completion of a multiple ascending dose study, and availability of preclinical data before being scored based on predefined criteria.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Data Security, Disinformation, Cyberthreat. It was started when Andrea discovered a vulnerability in Facebook’s group platform that allowed data to be scraped outside of the group. The problem is patients can’t predict benefit or harm based on how their data is used. Eric Perakslis, PhD.

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Rethinking Clinical Trials

MAY 25, 2023

Aspirin vs. Low Molecular Weight Heparin for Thromboprophylaxis: A Randomized Clinical Trial of Over 12,000 Orthopedic Trauma Patients (PREVENT CLOT) was conducted through METRC at 21 centers across the country. Therefore, it can be considered an acceptable option when clinicians, patients and hospital consider these data.

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Rethinking Clinical Trials

MARCH 15, 2023

The difference relates to how data is weighed. – It’s difficult to determine definitively if there is informative cluster size, but it would be interesting to evaluate in pilot data clusters. Two estimands will differ when there is informative cluster size in a trial.

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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

The Pharma Data

FEBRUARY 22, 2022

As part of its on-going work to track variants, WHO’s Technical Advisory Group on SARS-CoV-2 Virus Evolution ( TAG-VE ) met yesterday to discuss the latest evidence on the Omicron variant of concern, including its sublineages BA.1 Studies are ongoing to understand the reasons for this growth advantage, but initial data suggest that BA.2

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Protein Vaccination Vaccine Genetics 52

Rethinking Clinical Trials

AUGUST 23, 2022

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research.

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Rethinking Clinical Trials

FEBRUARY 9, 2023

The study team’s health informatics group developed a novel clinical decision support (CDS) tool, called IMPROVE-DD VTE CDS, which can be integrated into different electronic health record (EHR) systems. In doing this, they were able to replicate the data among different populations.

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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? ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. Susanna Naggie, MD, MHS.

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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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XTalks

JUNE 28, 2023

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. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

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Gene Therapy Gene Protein FDA Approval 98

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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Rethinking Clinical Trials

DECEMBER 6, 2023

There are several key design considerations for stepped-wedge design, including defining the estimand or what are you trying to estimate in the analysis, the key sources of variation, and how outcome data will be collected. Hughes, PhD) appeared first on Rethinking Clinical Trials. How will the treatment effect the outcome?

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