Biomarkers and Targeted Therapies Usage
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
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
