Applied Clinical Trials
A 2010 survey conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that sponsor companies are allocating resources, modifying organizational structures, and increasing investment in the development of personalized medicines (i.e., tailoring of medical treatment and healthcare delivery based on individual patient characteristics including genetic, molecular, and imaging).
A 2010 survey conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that sponsor companies are allocating resources, modifying organizational structures, and increasing investment in the development of personalized medicines (i.e., tailoring of medical treatment and healthcare delivery based on individual patient characteristics including genetic, molecular, and imaging).
The average percentage of company pipelines relying on biomarker data.
Responses from 25 companies show that all sponsors are using biomarkers and/or targeted therapies to evaluate compounds in discovery. The use of biomarkers and/or targeted therapies in clinical are less common at this time, with the highest incidence in early stages of development. Nearly 60 percent and 50 percent—on average—of sponsor company preclinical and Phase I/IIA clinical pipelines respectively rely on biomarker data. Only a third of late stage Phase IIb/IV clinical pipelines—on average—rely on biomarker data. The Tufts CSDD found that oncology is the therapeutic area the farthest along in integrating biomarkers and diagnostics. Development programs in cardiovascular, CNS, and immunologics are less advanced than oncology but they are making headway in integrating personalized medicine practices.— Tufts Center for the Study of Drug Development, http://csdd.tufts.edu
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.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.