Rethinking Clinical Trials

FEBRUARY 28, 2024

But there are concerns to developing DCTs including lack of standardization and validation, regulatory and ethical uncertainties, engagement vs. coercion, data security and privacy issues, technological literacy and access, resistance to change and adoption, and lack of “safe” sharing. from 2021 to 2026.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Clinical Research 141

Pharmaceutical Technology

NOVEMBER 9, 2022

Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. The program was put on hold in December 2020 following a patient report, but this was lifted in April 2021. million price tag.

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

Rethinking Clinical Trials

JANUARY 26, 2023

This study is looking at a particular subpopulation, where there is a lack of outcomes data. Patient recruitment is through a network of sites in different geographic locations managed by a collaboration of AROs. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Roots Analysis

MARCH 8, 2023

It is worth noting that smart labels contain a transponder code which can be read by sophisticated devices, including radio frequency identification device (RFID) tags and near-field communication (NFC) chips. While most smartphones can read NFC chips, RFID tags can only be read by specialized receivers.

Medicine 52

Medicine Production Manufacturing Containment 52

Rethinking Clinical Trials

APRIL 18, 2023

There are many hypothesized causes that may co-exist in the same patient, such as persistent virus or antigens, reactivation of other viruses, uncontrolled immune responses, damage to a wide range of organs and tissues, and injury to blood vessels and abnormal blood clotting. It’s all over the place.

Clinical Trials 219

Clinical Trials Clinical Trials Trials Immune Response 219

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).

Trials 141

Trials Clinical Research Coordinator Medicine Clinical Trials 141

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.

Marketing 130

Marketing Sales Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

MARCH 28, 2023

                                           Speakers Erin Holve, PhD, MPH, MPP Chief Research Infrastructure Officer, Patient-Centered Outcomes Research Institute (PCORI) Russell Rothman. Patients and caregivers are integrated into all phases of PCORnet®.-enabled enabled research.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

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.

Gene Therapy 130

Gene Therapy Gene Development Clinical Trials 130

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. In our research, we learned that patients actively do not want to see error bars and P values on graphs.

Clinical Trials 152

Clinical Trials Clinical Trials Research Trials 152

Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. Combining data from all markets, efficacy-related needs were identified as the most important unmet needs category. Cost-related unmet needs also scored highly.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

MAY 25, 2023

Aspirin is now the most commonly used VTE prophylaxis for Arthroplasty patients, in which Aspirin and LMWH are both safe and effective prophylaxis options. Aspirin as an oral pill is a less expensive and easier option for the orthopedic trauma population, which has a high proportion of uninsured patients.

Trials 130

Trials Clinical Trials Clinical Trials Compliance 130

World of DTC Marketing

SEPTEMBER 24, 2021

This drug was never about patients; it was about a company whose ego got too big and needed a savior in the form of a medicine that could bring in hundreds of millions of dollars. Many doctors also became upset at the idea of telling Alzheimer’s patients that the drug didn’t work. Biogen is in trouble.

Drugs 222

Drugs Pharma Companies Doctors Doctor 222

Rethinking Clinical Trials

MARCH 6, 2024

The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. Additional data sources came from EHR data, health plan claims, and program participation data including food visits and education.

Clinical Trials 141

Clinical Trials Clinical Trials Medicine Trials 141

Rethinking Clinical Trials

OCTOBER 27, 2022

Data Security, Disinformation, Cyberthreat. Patients use the internet to search for answers, and researchers use the internet to search for new solutions. The Light Collective is an organization that represents collective rights, interests, and voices of patient communities in healthcare technology. Andrea Downing. Key Points.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

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. The key is to have a deep understanding and control over the data being used.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

DECEMBER 12, 2023

For the Jumpstart trial, a number of refinements were made to make it more pragmatic, including the creation of Jumpstart using EHR data rather than patient or family member surveys, delivering the intervention to clinicians only, automated population of Jumpstart guide fields, and automated Jumpstart delivery to clinicians by email.

Trials 130

Trials Medicine Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

JULY 6, 2023

Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

NOVEMBER 21, 2023

The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement. The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Development 141

Intouch Solutions

APRIL 11, 2024

Commercial : Improved experience and communication between patients and doctors. Pharmacovigilance : Early identification of adverse drug reactions, higher data integrity and faster response times. Precision engagement is a data-driven approach developed for marketing and sales needs. So, what is precision engagement?

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

Rethinking Clinical Trials

FEBRUARY 16, 2023

ICD-Pieces studied patients with chronic kidney disease (CKD), diabetes and hypertension. The study used a patient-information sheet to inform patients about the research, how patient data would be handled, and an option to opt-out of including their data in the study. What should they agree (not object) to?

Clinical Trials 130

Clinical Trials Clinical Trials Medicine Trials 130

Rethinking Clinical Trials

SEPTEMBER 13, 2023

The trial operated under an IRB waiver of informed consent with a patient information sheet. Patients were randomized 1:1 in blocks of variable size, stratified by trial site with allocation concealed until randomization using opaque envelopes containing trial group assignment. for the video laryngoscope group and 70.8%

Trials 141

Trials Clinical Trials Clinical Trials Medicine 141

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.

Drug Delivery 52

Drug Delivery Manufacturing Drugs Marketing 52

Roots Analysis

JANUARY 28, 2024

Big Data in healthcare refers to the vast amount of data that is continuously expanding and cannot be efficiently stored or processed using traditional tools. Within the healthcare sector, structured data includes demographic details, vital indicators (like, height, weight, blood pressure, blood glucose).

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

Pharmaceutical Technology

JULY 14, 2022

Historically, the pharmaceutical industry has failed to meet the needs of this patient population. Most famously, the US passed its Orphan Drug Act in 1983, providing innovators with financial motivation to develop orphan drugs and meet the needs of these forgotten patients. Efforts have been made to change this.

Drugs 147

Drugs Medicine Marketing Development 147

XTalks

JUNE 28, 2023

Elevidys was granted FDA accelerated approval for the treatment of pediatric patients four to five years of age with DMD who have a confirmed mutation in the DMD gene. It is indicated for patients who do not have a pre-existing medical reason preventing treatment with the therapy.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.

Drugs 52

Drugs Generic Drugs FDA Approval Trials 52

Rethinking Clinical Trials

OCTOBER 4, 2022

The Clinical Trial Transformation Initiative (CTTI) envisions an evidence generating system with trials that are patient-centered, integrated into health processes, quality, leverage all available data, and improve population health. Tech support at the site level is important to addressing problems in a study. pctGR, @Collaboratory1.

Trials 130

Trials Clinical Trials Clinical Trials Production 130

Rethinking Clinical Trials

MARCH 1, 2023

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. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

APRIL 27, 2023

The reasoning for this temperature is unclear, though it likely represents what was considered the average body temperature of most patients. In a recent international survey of more than 270 centers, nearly half now use a cooler temperature dialysate in patient care of less than or equal to 36.0

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

JULY 9, 2023

BeatPain Utah, an NIH Pragmatic Trials Collaboratory Demonstration Project, is an embedded pragmatic clinical trial comparing the effectiveness of nonpharmacologic intervention strategies for patients with back pain seeking care in federally qualified health centers in Utah.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

FEBRUARY 9, 2023

This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

MARCH 15, 2023

The difference relates to how data is weighed. An example of this is when patients experience better outcomes in a large hospital compared to a small hospital when given the same medication. . Two estimands will differ when there is informative cluster size in a trial.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Not to mention the $56,000 annual price tag.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

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. It can also make patients more susceptible to complications like anemia, jaundice, infections and gallstones. Vertex-CRISPR’s Casgevy has a US list price of $2.2

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

Rethinking Clinical Trials

JULY 22, 2022

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. Six agents showed really good results and either changed clinical practice or showed efficacy and improved patient care.

Vaccination 130

Vaccination Vaccine Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. There were no differences observed in the relief of mild-to-moderate COVID-19 symptoms between patients taking Ivermectin-400 and the placebo. Were there concerns about having patients not associated with a site? Learn more about ACTIV-6.

Trials 169

Trials Pharmacy Medicine Clinical Trials 169