Centre of Research Excellence in Pulmonary Fibrosis’ Post

#Finerenone Meets Primary Endpoint in Phase III Study - https://lnkd.in/ej4T6Gcs Meets Primary Endpoint in a Phase III cardiovascular outcomes study, #Bayer recently announced the positive results from its Phase III FINEARTS-HF study, which evaluated the efficacy and safety of #finerenone in patients with heart failure with mildly reduced or preserved ejection fraction. This groundbreaking study has significant implications for#Bayer #Cardiovascular Outcomes #clinical trials #FINEARTS-HF Study #Finerenone #Heart Failure #Medical Research #Patient Care #Regulatory Approvals

How can #patient preference information (PPI) enhance #clinicaltrial design for heart failure patients? In October of 2018, MDIC’s Science of Patient Input (SPI) Heart Failure Working Group launched a PPI study to quantify heart failure patients’ willingness to accept device-related risks in exchange for potential improvements in health outcomes. The overarching objective was to develop a methodology by which #patientpreferences could be incorporated into clinical trial design for future HF devices. Read more at https://lnkd.in/etmKkjsm #heartfailure #hearthealth #medtech #medicaldevices #FDAapproval #patientinput

cTAP Study indicates Duchenne muscular dystrophy clinical trial enrolment criteria should expand beyond ambulatory status. Study co-funded by CureDuchenne and cTAP highlights need for more specific enrolment criteria that could increase patient participation and drive more comprehensive therapeutic evaluation.  https://lnkd.in/eUZWtiKA #DMD #Duchenne #DuchenneMuscularDystrophy #ClinicalTrials

Randomization in clinical trials involves the chance selection of two or more alternative treatments, not by deliberate choice. The selected treatment is administered with the utmost professional care and expertise, and the outcomes of each treatment are systematically compared. Analyses are conducted at regular intervals throughout the trial, which may span several years. Once one treatment is conclusively proven to be superior, the trial is halted. This ensures that the least beneficial treatment is given to the fewest number of patients.

https://lnkd.in/gtFetX69 A randomized, open‑label, multicentered parallel‑group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients

When patients present to the emergency department (ED), 70% require a peripheral intravenous catheter (PIVC). A quarter of these patients have difficult intravenous access, with half needing multiple attempts for successful placement. This can lead to venous depletion, patient dissatisfaction, treatment delays, and increased costs. In a randomised controlled trial funded by EMF, Dr Grace Xu compared the insertion success and device failure of a novel long PIVC with a retractable coiled guidewire (GW-PIVC), to standard care PIVC. Analysing data from 446 participants, the study found that standard PIVC had a better insertion rate, higher patient satisfaction, and lower costs than GW-PIVC. Dr Xu's research highlighted the need for further studies to address complex insertion techniques and training gaps. Dr Xu was part of another study into PIVC insertion, which identified insufficient training as a key barrier to following the PIVC clinical care standard, negatively impacting success and patient satisfaction. EMF Funded LOVE-DIVA Study: https://lnkd.in/eqDSfbMY Authors: Hui (Grace) Xu, Amanda Corley, Emily R. Young, Anna Doubrovsky, Robert S. Ware, Clifford Afoakwah, Carrie Wang, Scott Stirling, Nicole Marsh For more information and publications: - Complementary Qualitative LOVE-DIVA Study: https://lnkd.in/eRFAFGyS - PIVC related studies: https://lnkd.in/esVDiEsD https://lnkd.in/eDUAq6Kz https://lnkd.in/e8t3yvCR #EMFResearch #EmergencyMedicineResearch #MedicalResearch #PIVCResearch

The comprehensive Positive Quality Intervention (PQI) on the utilization of nirogacestat in the management of adults with progressing desmoid tumors (or fibromatosis/aggressive fibromatosis) provides insight into the initiation and management protocols for adult patients. Highlighting the latest guidelines, this precise and concise clinical guidance resource outlines the dosage forms now available, including: 50 mg (180-count bottle) 100 mg (14-count blister pack) 150 mg (14-count blister pack) tablets Stay informed and elevate your clinical practices with this invaluable resource tailored for optimal patient care. https://bit.ly/3ulJvXa

New MDCG 2024-10 "Clinical evaluation of orphan medical devices" published on 25/06/2024 Orphan devices: device specifically intended to benefit patients in the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12,000 individuals in the European Union per year; and at least one of the following criteria are met: - there is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition, or -the device will offer an option that will provide an expected clinical benefit compared to available alternatives or state of the art for the treatment, diagnosis, or prevention of this disease/condition, taking into account both device and patient population-specific factors.

📣 BPL-003 clinical trial progress A few weeks ago, we announced the positive results from the BPL-003 Phase 2a study in patients with treatment resistant depression who were not on oral antidepressants (SSRIs). The first patient has now been dosed in the second part of the Phase 2a study investigating BPL-003 in patients who are currently on a course of SSRI antidepressants.  Many clinical trials investigating psychedelics require patients to discontinue taking SSRIs. However, many patients prefer to continue taking SSRIs, even if they’re not effective, due to the potential side effects of coming off them. The findings from this part of the BPL-003 Phase 2a study will help to inform whether BPL-003 could be a safe and effective therapy in combination with SSRIs, which could allow for broader patient access, should BPL-003 reach approval. Read the full release here: https://lnkd.in/eC3eAPEt #MentalHealth #Psychedelics #ClinicalTrial

Congratulations to Pindara for their participation in the clinical trial DREAMM-7 and the impact they have had on the patients in this trial! The DREAMM-7 trial results have shown a benefit of Triplet Regimen in Relapsed or Refractory Multiple Myeloma.   Results from the DREAMM-7 multiple myeloma clinical trial were presented at the recent ASCO plenary series displaying advancing, positive results, along with a manageable safety profile that “suggest that BVd can potentially be a new standard of care in second-line treatment or later for relapsed and refractory multiple myeloma”.   Maria-Victoria Mateos Manteca, of the Hospital Universitario de Salamanca said: “BVd demonstrated a statistically significant and clinically meaningful progression-free survival benefit, with a median progression-free survival that was 23 months longer than with DVd”.   📑 To read more about this study copy this link: DREAMM-7 Confirms Benefit of Triplet Regimen in Relapsed or Refractory Multiple Myeloma - The ASCO Post #clinicaltrial #peoplecaringforpeople #myeloma #multiplemyeloma #clinicalcare #treatment #advancingcare #medicine #healthcare