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tag clinical-trial 
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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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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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. The other trial failed to reach its goal, though the company was encouraged by data from a subset of study participants who got more of the drug. Washington Post.
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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. There are several strategies that will help increase diversity in CVD trials. Many high school and college students are moving away from the sciences.
169 
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.
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Rethinking Clinical Trials
SEPTEMBER 28, 2023
The Parent-Focused Redesign for Encounters, Newborns to Toddlers (PARENT) study was a randomized controlled trial of PARENT verses usual care for parents with infants 12 months and younger over a 12-month study period. The first year was spent allowing the clinics to make the project their own, with input from parents and clinicians.
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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. The 5 trials, RECOVER-VITAL, RECOVER-AUTONOMIC, RECOVER-SLEEP, RECOVER-NEURO, and RECOVER-ENERGIZE, will enroll about 2,600 total participants, and each trial will include between 25-100 sites.
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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. Decentralized trials require novel technology and digital endpoints.
130 
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
FEBRUARY 20, 2024
Speaker Jeffrey Carson, MD, MACP Principal Investigator and Study Chair MINT Trial Provost-New Brunswick, Rutgers Biomedical Health Sciences Distinguished Professor of Medicine Richard C. Trials in other clinical settings suggest the use of restrictive transfusion strategy, which is a lower hemoglobin level, is safe.
130 
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. The trial was for adults with HbA1c greater than 8.0,
141 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. University of Michigan Medical School.
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Rethinking Clinical Trials
JULY 6, 2023
Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.
130 
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.
169 
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
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. The clinic’s priorities should drive the design of the trial. “We
130 
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
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.
130 
Rethinking Clinical Trials
MARCH 15, 2023
An estimand is a precise description of the treatment effect that a researcher aims to estimate from the trial. Two estimands will differ when there is informative cluster size in a trial. Statisticians working on pragmatic trials should consider estimand and tailor analysis around the chosen estimand.
130 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. Another issue to think about with stepped-wedge trials is potential sources of variation. Speaker James P.
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Rethinking Clinical Trials
JANUARY 26, 2023
EVOLVE-MI is a pragmatic, effectiveness outcome trial of Evolocumab dosed within 10 days of a myocardial infarction (MI). Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. EVOLVE-MI is enrolling 4,000 patients in 3 countries.
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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.”
109 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.
130 
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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Pharmaceutical Technology
JANUARY 17, 2023
On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. In addition to facilitating loss of fat, the Phase II trial also showed that a lean mass gain of 4.5% was observed in the study.
130 
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. Initially, the randomization of the trial was 1:1 Metformin or Placebo. The primary outcome of the trial was negative.
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.
130 
Rethinking Clinical Trials
MAY 25, 2023
A pilot study, called the ADAPT trial, demonstrated feasibility, similar in-patient compliance and similar post-discharge adherence for the 2 options. The pragmatic randomized control trial was designed from a hospital policy perspective. This inspired the research team to shift the primary outcome to death.
130 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.
130 
Rethinking Clinical Trials
MARCH 1, 2023
One network is the lead, but the trial will be available in all four U.S. We are working on inclusion and making sure all of our trials have buy in across the group. They are both approved and used widely in lung cancer, and combining two existing agents is logistically and clinically simpler.
130 
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 RA PRO dashboard was tested as part of a stepped wedge, cluster randomized trial at the clinician level. 552 unique patient participated in the trial.
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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.
130 Rethinking Clinical Trials
JANUARY 9, 2024
Unfortunately, this can rarely happen, so people consider using the missing at random (MAR) model, which models the missingness process using the observed data in cluster randomized trials. This research addresses two challenges – outcomes can be missing, and data for individuals within the same cluster are likely to be correlated.
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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.
152 
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.
130 Rethinking Clinical Trials
DECEMBER 14, 2022
Senior Scientist, Clinical Epidemiology Program. Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. There are two main types of clinical trials: patient randomized trial and cluster randomized trial (CRT). – Should we be allowing stepped wedge trials in the Collaboratory? Key Points.
130 
Rethinking Clinical Trials
FEBRUARY 13, 2023
The NITRIC Trial was a double blind, multicenter, randomized, parallel-group trial recruiting at 6 pediatric cardiac surgical centers in Australia, New Zealand, and The Netherlands. The design of platform trials can build on the lessons learned from this study. COVID-19 absorbed everyone in the middle of the trial.
130 
Rethinking Clinical Trials
SEPTEMBER 13, 2023
The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. The trial operated under an IRB waiver of informed consent with a patient information sheet. Discussion Themes -Why did the RSI trial follow a different path – not a waiver of consent?
141 
Rethinking Clinical Trials
FEBRUARY 14, 2024
DCP learned that leveraging health systems for large-scale clinical trials is feasible. How long did the start up for the trial take? Other key success factors were the creative thinking across the study team and the excellent study coordination and partnership within the health system.
152 
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.
130 Rethinking Clinical Trials
APRIL 27, 2023
The MyTEMP trial is a pragmatic, cluster randomized controlled trial in Ontario, Canada, to determine if adopting a default center-wide policy of personalized cooler dialysate is superior to a standard temperature dialysate of 36.5 Cluster randomized trials of hemodialysis center-wide policies raise complex ethical issues.
130 
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. More than 13,000 patients were considered eligible for the UH3 trial and more than 9,500 were randomized in the 4 arms, with about 2,300 patients in each of the arms.
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