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Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance.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

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. There is billing potential here.

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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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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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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

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

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

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 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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Rethinking Clinical Trials

MAY 10, 2023

Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. We are looking forward to supporting more.

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Rethinking Clinical Trials

AUGUST 30, 2023

   Speaker Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Slides Keywords Patient-Reported Outcomes, Rheumatoid Arthritis, EHR Key Points Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA).

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Rethinking Clinical Trials

OCTOBER 11, 2023

Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. Second, you shouldn’t tell the staff collecting the outcome data which arm the various sites are in.

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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

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

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

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

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

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

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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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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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. Key Points.

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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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Cloudbyz

JUNE 5, 2023

In the fast-paced world of clinical research, managing essential Trial Master Files (TMFs) efficiently, while ensuring quality and compliance, is paramount. Generative AI can employ natural language processing techniques to intelligently extract key data points, such as patient demographics, adverse events, and protocol deviations.

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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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Rethinking Clinical Trials

DECEMBER 6, 2023

Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Slides Keywords Design, Analysis, Stepped-Wedge Trial Key Points Stepped-wedge design is typically run by clusters that are randomized. Hughes, PhD) appeared first on Rethinking Clinical Trials.         Speaker James P.

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Rethinking Clinical Trials

FEBRUARY 16, 2023

It is not uncommon to see waivers of consent in pragmatic clinical trials because many trials meet minimal risk criteria and involve numerous institutions and thousands of subjects. Michael Ho, MD, PhD) appeared first on Rethinking Clinical Trials. The study had a waiver of informed consent. Pearl O’Rourke, MD; David S.

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Rethinking Clinical Trials

NOVEMBER 21, 2023

Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics. Patients could text back with clinical questions or questions about the study. responded with a question for a clinical pharmacist. About 50% of participants responded with a question, and 9.2%

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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. There is plenty of data that shows that. We have a long way to go; we are talking about data we don’t currently collect. Wilkins, MD, MSCI.

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Rethinking Clinical Trials

APRIL 27, 2023

This change in practice is based on data that suggests the at cooler (vs. A patient or their nephrologist could decide to opt-out of the randomly allocated center-wide default policy but could not opt out of the symptom data but not de-identified health records. Dixon, PhD MSc) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

DANFLU-1, Pragmatic Clinical Trials. and the Danish Registry of Causes of Death (a registry of long-term clinical outcomes including hospitalizations, outpatient visits, procedures, prescriptions, mortality). .); The DECODE trial used registry data to identify patients with chronic kidney disease. University of Copenhagen.

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Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. The data of what is happening with social media is not available unless you are collaborating with social media.    Speaker Carl T.

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Rethinking Clinical Trials

JULY 19, 2023

However, these therapies are highly underused in routine clinical practice. The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies.

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Rethinking Clinical Trials

SEPTEMBER 16, 2022

One challenge is that academic medical institutions traditionally have multiple missions, including research, patient care, and education, and systemically integrating learning into clinical operations is novel addition to the traditional missions. Steven Joffe, MD, MPH) appeared first on Rethinking Clinical Trials. Key Points.

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Rethinking Clinical Trials

MAY 5, 2023

Assistant Professor of Medicine and Biomedical Informatics Medical Director, VICTR Center for Learning Healthcare Vanderbilt University Medical Center Slides Keywords Pragmatic Clinical Trials, Cluster-crossover Trial Key Points More than 3 million adults receive invasive mechanical ventilation each year in the U.S. Semler, M.D.,

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