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tag clinical 
Bio Pharma Dive
FEBRUARY 25, 2021
Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed. Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment.
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Fierce Pharma
SEPTEMBER 22, 2023
Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break.
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Bio Pharma Dive
JUNE 30, 2021
The influential nonprofit maintains that the clinical trial evidence supporting Aduhelm is insufficient to prove a health benefit. But if some efficacy is assumed, ICER argues Biogen's $56,000 price tag is far too high.
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World of DTC Marketing
JUNE 1, 2021
The first clinic; trials were everything but encouraging but so much depend ended on this drug’s approval that Biogen returned and recited the data. Knopman, a Mayo Clinic neurologist who treats Alzheimer’s patients and is a member of the FDA advisory committee. Will they follow the science or will they put a price tag on hope?
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Medical Xpress
MARCH 8, 2023
Before new therapies can reach patients, they must be tested in clinical trials in representative populations to show that they work and are safe. Failure to enroll enough participants in trials can delay the arrival of new therapies in the clinic and inflate their eventual price tags.
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STAT News
JANUARY 6, 2023
Such decisions are based on myriad factors, starting with the average $26,500 price tag. But there are other considerations, including the quality of the clinical trial data, side effect concerns, the patient population for which the medicine is approved, and budgetary constraints. Continue to STAT+ to read the full story…
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Pharma Tutor
MARCH 26, 2022
A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH. Read more about A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH Log in or register to post comments About Authors. MANISHA KOTADIYA*, JAYDEEP SAVALIYA. Ahmedabad, Email ID: jaydeepsavaliya27@gmail.com.
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
DECEMBER 20, 2023
Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinical trial diversity and cardiovascular health for all.
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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
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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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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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
FEBRUARY 28, 2024
Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% from 2021 to 2026. I think we must.
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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. Setting clear inclusion/exclusion criteria based on highest level clinical evidence is crucial.
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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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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
NOVEMBER 16, 2022
Ethics, Data Sharing, Pragmatic Clinical Trials. When you apply these rules to pragmatic clinical trials (PCTs), there are ethical challenges because PCTs often use waivers or alterations of informed consent and are embedded into ongoing clinical care using extant data. Assistant Professor of Obstetrics & Gynecology.
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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
Prior to the development of Camzyos and aficamten, obstructive HCM has not been the target of clinical trial development, so these two therapeutics would benefit a neglected patient population. of sales in 2021 and 2031 respectively. The second highest contributing market is APAC, generating 33.2%
130 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
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 mitigate bias because of incomplete data? For the CKD example, we combined data from Duke and claims data.
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Rethinking Clinical Trials
NOVEMBER 1, 2022
Duke Clinical Research Institute. On March 21, 2020, in response to the COVID-19 pandemic, PCORI contacted leadership at Duke Clinical Research Institute and PCORnet and a decision was made to focus on the space of healthcare workers. ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers.
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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
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.
130 Rethinking Clinical Trials
FEBRUARY 20, 2024
Chair in General Internal Medicine Rutgers, Robert Wood Johnson Medical School Keywords Transfusion; MI; MINT; Anemia; Clinical trials Key Points Anemia is common in patients with acute MI. Trials in other clinical settings suggest the use of restrictive transfusion strategy, which is a lower hemoglobin level, is safe. Reynolds, M.D.
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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
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
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.
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.
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. Learn more Read more about Decentralized Clinical Trials. Discussion Themes -As an early adopter of DCTs, could you share your experience and perspective on these issues?
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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
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. Every PCORnet®.
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STAT News
OCTOBER 6, 2022
Even a drug-price watchdog, the Institute for Clinical and Economic Review, deemed the $2.8 million tag as cost effective for a Bluebird Bio drug called Zynteglo for the blood disorder beta thalassemia, Arbuckle said in an interview.
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Rethinking Clinical Trials
JUNE 29, 2022
Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design. The post June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH) appeared first on Rethinking Clinical Trials. and the FDA Draft Guidance for RWD/RWE. pctGR, @Collaboratory1.
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Rethinking Clinical Trials
OCTOBER 18, 2023
The PCORnet Common Data Model (CDM) includes data available from Clinical Research Networks. Some data, such as basic clinical data and demographics, are ready for research. First steps are getting the data in such a state that would allow us to learn about some of those social determinants of health.
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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. Clinician buy-in and understanding the social component of clinical work was essential to the pragmatic trial.
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Rethinking Clinical Trials
FEBRUARY 14, 2024
DCP learned that leveraging health systems for large-scale clinical trials is feasible. When people understood what we were trying to do, embed research into clinical care, people really engaged and a few regional directors made participation one of the drivers of research in their region and helped us get initial groundwork.
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Rethinking Clinical Trials
MARCH 1, 2023
They are both approved and used widely in lung cancer, and combining two existing agents is logistically and clinically simpler. S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. .
130 Rethinking Clinical Trials
JANUARY 26, 2023
Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD) appeared first on Rethinking Clinical Trials.
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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
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. Granger, MD; Neha J.
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. Koopman, MD, MS) appeared first on Rethinking Clinical Trials.
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Rethinking Clinical Trials
AUGUST 22, 2022
The COVID-OUT Trial is a remotely delivered, Phase 3, de-centralized clinical trial at 6 participating institutions to see if Ivermectin, Metformin or Fluvoxamine would prevent severe COVID-19. We used Google Ads and partnerships with some testing clinics. Division of Biostatistics. University of Minnesota School of Public Health.
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