Efforts by drug companies to streamline and improve the execution of clinical study designs-to counter mounting costs and shorten development times associated with bringing new drugs to market-are yielding positive benefits.
Efforts by drug companies to streamline and improve the execution of clinical study designs-to counter mounting costs and shorten development times associated with bringing new drugs to market-are yielding positive benefits, according to an assessment recently completed by the Tufts Center for the Study of Drug Development and reported in the September/October Tufts CSDD Impact Report.
According to Tufts CSDD, greater emphasis by drug sponsors on upfront planning and governance to assess and challenge protocol feasibility and new approaches to development, including facilitated review mechanisms and greater use of adaptive trial designs, are helping to improve data quality and success rates, while cutting costs. Other findings from the analysis, include the following:
Read the full release here.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.