This paper focuses on the use of novel technologies and innovative trial designs to accelerate evidence generation and increase pharmaceutical Research and Development (R&D) productivity, at Bristol Myers Squibb. We summarize learnings with case examples, on how we prepared and continuously evolved to address the increasing cost, complexities, and external pressures in drug development, to bring innovative medicines to patients much faster. These learnings were based on review of internal efforts toward accelerating R&D focusing on four key areas: adopting innovative trial designs, optimizing trial designs, leveraging external control data, and implementing novel methods using artificial intelligence and machine learning.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.drudis.2024.103952 | DOI Listing |
Urol Oncol
January 2025
Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy; Department of Medical Oncology, IRCCS San Raffaele University, Milan, Italy.
Treatment options for recurrent high-risk non-muscle-invasive bladder cancer (HR NMIBC) and muscle-invasive bladder cancer (MIBC) are limited, highlighting a need for clinically effective, accessible, and better-tolerated alternatives. In this review we examine the clinical development program of TAR-200, a novel targeted releasing system designed to provide sustained intravesical delivery of gemcitabine to address the needs of patients with NMIBC and of those with MIBC. We describe the concept and design of TAR-200 and the clinical development of this gemcitabine intravesical system in the SunRISe portfolio of studies.
View Article and Find Full Text PDFJ Minim Invasive Gynecol
January 2025
Department of Anaesthesiology, Onze Lieve Vrouwe Gasthuis (OLVG), Oosterpark 9, 1091 AC, Amsterdam, the Netherlands.
Study Objective: To investigate whether intracervical injection of terlipressin during hysteroscopic surgery could reduce the amount of intravasation, the incidence and severity of gas embolism, and the COHb levels in the blood.
Design: Randomized double-blind controlled trial.
Setting: Gynecologic surgical unit in a general hospital.
Am J Obstet Gynecol MFM
January 2025
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA. Electronic address:
Objective: To evaluate the effect of nitroglycerine on placenta delivery after retained placenta DESIGN: Systematic review with meta-analysis DATA SOURCES: MEDLINE, PROSPERO, Scopus, ClinicalTrials.gov, EMBASE, Sciencedirect, the Cochrane Library, Scielo were searched from their inception until February 2024.
Eligibility Criteria For Selecting Studies: We included all randomized clinical trials comparing use of nitroglycerine (i.
Asia Pac J Ophthalmol (Phila)
January 2025
Rescue, Repair and Regeneration Theme, UCL Institute of Ophthalmology, London, United Kingdom. Electronic address:
Purpose: Recovery rate of rod photoreceptor sensitivity (S2 gradient) following a bleach is reduced in age-related macular degeneration (AMD) due to diminished delivery of retinol across a grossly altered Bruch's membrane. Since triterpenoid saponins are known to improve transport across Bruch's, we have assessed their possible use for reversing the visual deficits in AMD.
Design: Double-blind, placebo controlled randomised clinical trial.
Lancet Rheumatol
January 2025
Department of Rheumatology, Université de Bretagne Occidentale, CHU Brest, INSERM (U1227), LabEx IGO Brest, France.
Background: Moderate doses of glucocorticoids result in improvements in nearly all patients with polymyalgia rheumatica, but related adverse events are common in older individuals. We aimed to evaluate whether treatment with baricitinib (a Janus kinase 1/2 inhibitor) results in disease control without the use of oral glucocorticoids in people with recent-onset polymyalgia rheumatica.
Methods: We conducted a randomised, double-blind, placebo-controlled, parallel-group trial at six expert centres in France.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!