More Pipeline Balance
ROI from clinical research can suffer when too many research organizations seek to develop treatments for similar conditions and indications
ROI from clinical research can suffer when too many research organizations seek to develop treatments for similar conditions and indications, making it more difficult for any one pharma company to achieve medical and financial success. Financial analysts note that one-third of R&D spending is going into oncology and inflammatory conditions, and that pipelines also are over-crowded with potential treatments for melanoma and rheumatoid arthritis. Yet research programs have shrunk for new antibiotics, as well as for treatments for heart disease and central nervous systems disorders, which affect larger patient populations.
Much of the enthusiasm for developing new cancer therapies lies in the ability to target population subsets, which often supports designation as an orphan drug and/or breakthrough therapy. Such status reduces regulatory fees and opens the door to added advice from FDA experts and speedy approval, based on small, limited studies.
In some cases, single-arm studies may be sufficient to demonstrate activity, even though such limited trials provide little information on safety, explained Richard Pazdur, irector of the Office of Hematology and Oncology Products in the Center for Drug Evaluation & Research (CDER). Pazdur observed at the FDA/CMS Summit in December that he was not a “big fan” of single-arm studies a few years ago. But for a drug with a 50% response rate for a condition with no existing effective therapy, a limited study may be enough. However, the emergence of more oral cancer therapies for chronic use may require sponsors to look more at safety, Pazdur added, noting that clinical trials for such drugs have to capture toxicities and examine what is a tolerable dose.
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.
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.
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.
