The Biotechnology Industry Organization today reaffirmed and broadened its long-standing commitment to improving human health...
TheBiotechnology Industry Organization (BIO) today reaffirmed and broadened its long-standing commitment to improving human health through the development of innovative therapies by releasing Principles on Clinical Trial Data Sharing, which were adopted by its Health Section Governing Board.
The following statement may be attributed to BIO President and CEO Jim Greenwood:
“BIO recognizes that responsible clinical trial data sharing advances public health and scientific discourse, honors research participants’ expectations of privacy through informed consent, and promotes biomedical innovation.
"These Principles reflect our support for these goals, while maintaining incentives to invest in biomedical research and recognizing the human and financial resource constraints of small, pre-revenue enterprises.
“Our members currently share research data in a number of ways, routinely publishing their clinical trials in peer-reviewed scientific journals and presenting their results at scientific meetings and workshops.
“These Principles reaffirm our support for these efforts, and represent a commitment to make additional information available to the public, qualified researchers, and patients participating in clinical trials.
“We believe these Principles will enhance scientific knowledge to advance public health and patient care. We remain committed to working with the broader scientific community to develop knowledge that will improve drug development, enhance public health, and reinforce public confidence in the safety and efficacy of our medicines.”
For more information on the biotech industry, please visit www.bio.org.
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.
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.
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.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.