Rethinking Clinical Trials

APRIL 27, 2023

However, in two recent systematic reviews the overall quality of evidence for dialysate cooling was deemed low with a high risk of bias. There is a high risk of these events in the hemodialysis population with a cumulative instance at 30% at 4 years. Where the risks and benefits are equal, but I wouldn’t want to be randomly assigned.

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Rethinking Clinical Trials

JANUARY 17, 2024

The therapeutics and ethics committees grouped immunocompromised patients into 3 risk categories, with a lottery for those patients in group 1 (highest risk). Tags #pctGR, @Collaboratory1 The post Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K.

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Clinical Trials Clinical Trials Antibody Trials 173

Rethinking Clinical Trials

APRIL 18, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH) appeared first on Rethinking Clinical Trials. RECOVER is a patient-centered, integrated, adaptive research network.

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Rethinking Clinical Trials

JANUARY 26, 2023

There is little question about the utility of LDL lowering as a means of cardiovascular risk reduction. The treatment is on-label because anyone with an acute coronary has at risk cardiovascular disease so technically it is on-label. This study is looking at a particular subpopulation, where there is a lack of outcomes data.

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Trials Clinical Trials Clinical Trials Medicine 130

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. By 2045, more than 50% of the population in the U.S. is expected to be other than non-Hispanic white. With the current ability to become pregnant this can affect women up to the age of 50.

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Clinical Trials Clinical Trials Trials Cardiology 173

Rethinking Clinical Trials

FEBRUARY 28, 2024

Under RBM, the process by which study materials get to participants should be considered high risk and monitored accordingly. Baseline state, treatment, outcome, and safety data are critical to understanding treatment benefits and risks. The skills may also vary between trials and getting participants the care they need.

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Clinical Trials Clinical Trials Trials Clinical Research 143

Rethinking Clinical Trials

FEBRUARY 9, 2023

Electronic alerts incorporating VTE risk models could increase appropriate use of Thromboprophylaxis and reduce symptoms of VTE. The study team developed the tool using high-quality evidence from randomized trials related to risk factors for subpopulations and guideline recommendations.

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Clinical Trials Clinical Trials Trials Development 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 evaluating the risk of reinfection with BA.2 Further, although BA.2 2 compared to BA.1.

Protein 52

Protein Vaccination Vaccine Genetics 52

pharmaphorum

DECEMBER 17, 2020

If we instead acknowledge that there are risks just like anything else in medicine and life, it’s a more effective message.”. Additionally, we will soon introduce a new vaccine tag to detect and tag all videos with words and hashtags related to the COVID-19 vaccine,” says Morgan. “We

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Rethinking Clinical Trials

AUGUST 22, 2022

Patients with diabetes or prediabetes were not excluded (except for those on insulin or sulfonylurea); pregnant patients were not excluded for the Metformin arm; the trial restricted participants to people who were overweight or obese to enrich the population for having a high risk of outcomes and for anti-inflammatory hypotheses around Metformin.

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Trials Clinical Trials Clinical Trials Insulin 130

XTalks

DECEMBER 13, 2023

Current treatments for sickle cell disease include blood transfusions but patients often have episodes of intense pain and an increased risk of stroke. A bone marrow transplant from a donor can offer a potential cure, but it is often difficult to find a matching donor and the procedure carries the risk of rejection by the immune system.

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Gene Therapy FDA Approval Gene In-Vivo 98

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). WHO’s TAG-VE will continue to monitor and evaluate the data as it becomes available and assess how mutations in Omicron alter the behaviour of the virus. Effectiveness of prior SARS-CoV-2 infection.

Vaccination 52

Vaccination Vaccine Genome Genomics 52

Rethinking Clinical Trials

FEBRUARY 14, 2024

The VA IRB determined DCP was a minimal risk study, with less restrictive eligibility criteria and EHR-based safety and outcome monitoring. Both drugs have a well-established safety profile and would be a good fit for a pragmatic design. At the time, more than 95% of VA patients received hydrochlorothiazide for thiazide-type diuretic.

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Rethinking Clinical Trials

AUGUST 10, 2023

There are still risks associated with this process, but gamifying the game could ultimately create a more individualized approach to health care that prioritize the needs of each patient. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game?

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Rethinking Clinical Trials

SEPTEMBER 13, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc) appeared first on Rethinking Clinical Trials. For moderately experienced operators, VL increased by 6%.

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Trials Clinical Trials Clinical Trials Medicine 143

pharmaphorum

AUGUST 21, 2022

There is still a pressing need for antidepressant therapies that can start to work more quickly than current tricyclic or selective serotonin reuptake inhibitor drugs can take weeks to elevate mood, placing severely affected patients at risk of self harm before they kick in.

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pharmaphorum

JANUARY 5, 2022

Excluded from that study are patients with EGFR mutations, and AbbVie is looking specifically at this group in a phase 1 study that is looking at the combination of Teliso-V and AstraZeneca’s EGFR inhibitor Tagrisso (osimertinib), to see if the ADC can boost efficacy and potentially reduce the risk of resistance developing.

Antibody 111

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Pharmaceutical Technology

MAY 2, 2023

While initially only approved for metastatic disease, ICIs have now moved into earlier disease settings, reducing the risk of disease progression and relapse. 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.

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Rethinking Clinical Trials

OCTOBER 26, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. The initiative would bring to the U.S.

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Clinical Research Clinical Trials Clinical Trials Research 143

pharmaphorum

JUNE 12, 2022

The panel voted 13 to 0 on the question of whether beti-cel’s benefits outweighed the risks of the gene therapy in patients with beta thalassaemia who are dependent on blood transfusions, in a dream result for the biotech which just a few weeks ago was expressing doubts about its ability to continue as an operating concern.

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. While stem cell transplants can cure the condition, their use is limited due to some of the risks that come with them. Also known as lovo-cel, bluebird bio’s product is a lentiviral gene therapy.

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

Rethinking Clinical Trials

MAY 19, 2023

Researchers assessed the effect of the data visualization on patient risk perception and the interaction of health literacy, numeracy, and graph literacy with the data visualization. Starting in 2015, researchers held 10 focus groups with patients, family medicine and general internal medicine physicians and 1 CMIO.

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Rethinking Clinical Trials

MAY 5, 2023

It was important to us that clinicians exercise their autonomy when they had the evidence needed to provide treatment Tags #pctGR, @Collaboratory1 The post Grand Rounds April 28, 2023: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial (Matthew W.

Trials 130

Trials Clinical Trials Clinical Trials Development 130

XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Gene Therapy Gene Protein FDA Approval 98

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. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P.

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Clinical Trials Clinical Trials Medicine Trials 130

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Joanna Carlish, managing director, financial services, Tag Americas. Virtual connections.

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Regulation Marketing Sales Branding 97

Rethinking Clinical Trials

DECEMBER 14, 2022

The patient randomized trial is always preferable; cluster randomized trials should only be used when there is no other choice because CRTs will always require a larger sample size, have higher risks of bias, be more vulnerable to chance imbalance between arms, and are more complicated to design and analyze. pctGR, @Collaboratory1.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

NOVEMBER 21, 2023

Nudge used an opt out approach, with IRB approval because it was a low-risk intervention and having patients consent on a large scale would be challenging and might bias the sample to more adherent patients. Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics.

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Clinical Trials Clinical Trials Trials Development 143

Rethinking Clinical Trials

OCTOBER 11, 2023

The Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) initiative at the National Heart, Lung, and Blood Institute (NHLBI) is their first major effort to conduct implementation research. However, I don’t have a great general solution for that issue at this point.

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Clinical Trials Clinical Trials Trials Research 154

The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

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Vaccination Vaccine Trials Protein 52

Rethinking Clinical Trials

JANUARY 19, 2023

Beneficence involves minimizing risks, and ensuring they stand in reasonable relation to potential benefits. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. That’s difficult.

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Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. However, extended market exclusivity is often associated with high drug pricing and limited patient access.

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Drugs FDA Approval Marketing Development 246

pharmaphorum

MAY 17, 2021

C5 inhibitor Soliris – which has a list price in the US of more than $500,000 per year – has been a standard therapy for the rare disorder since 2007, and was joined on the market by longer-acting follow-up Ultomiris in 2018 which launched with a price tag of around $450,000 per year. billion and $1.1

Drugs 52

Drugs FDA Approval Marketing Clinical Trials 52

Rethinking Clinical Trials

OCTOBER 27, 2022

Researchers need to overcome the risks of online tools and increase the benefits. The questions are how are you going to play online and how are you going to conduct your research in a way that is most effective and will keep everyone safe? How do we maintain research access when health care access is limited in some of these states.

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XTalks

NOVEMBER 10, 2020

Inherent risks can be minimized by: Allowing information to be shared with various stakeholders across global supply chains. Implementing these technologies would require investing in handheld computers and tablets, barcode label printers and scanners, and special labels and tags.

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pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

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Sales Doctors Doctor Gene Therapy 122

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

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