James Miessler

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Sponsors Face Fewer Financial Hits for Drug Delays Today, New Data Show

Aug 23, 2024 | centerwatch.com | James Miessler

The average daily cost for trials and drug development delays has dropped considerably for sponsors over the years, new data from the Tufts Center for the Study of Drug Development (CSDD) show, owing to a number of factors. The center’s latest Impact Report, which updates a number of outdated financial measures, is likely to be practicable for stakeholders from a strategic business perspective, says Ken Getz, executive director of Tufts CSDD.
New Report Addresses Trial Scarcity, Mapping Trial Distribution, County Demographics

Jul 15, 2024 | centerwatch.com | James Miessler

In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier to trial participation, digging deep into demographics and distribution of trials across US counties, as well as offering an interactive map tool filterable by therapeutic area.
FDA Delivers Long-Anticipated Guidance on Diversity Action Plans

Jun 28, 2024 | centerwatch.com | James Miessler

By James Miessler The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans.
EU Launches Two New Pilot Programs Amidst Activation of Transparency Regs

Jun 21, 2024 | centerwatch.com | James Miessler

The European Medicines Agency (EMA) is continuing efforts to improve trials in the trade bloc, announcing two new programs that will offer support on clinical trial applications as new transparency rules under its Clinical Trials Information System (CTIS) come into effect.
Sites May Be Underprepared for ICH E6 Revision, Survey Indicates

Jun 17, 2024 | centerwatch.com | James Miessler

Sites appear less informed and prepared than sponsors for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. The greatly revised version of the international standard that has guided the clinical trials community since 1996, expected to be finalized this fall, includes many changes that would impact sites’ conduct of trials (The CenterWatch Monthly, Sept. 1, 2023).
Balance AI Potential with Unique Challenges, FDA Drug Policy Chief Says

Jun 7, 2024 | centerwatch.com | James Miessler

Recent years have shown AI’s potential for advancing drug development is undeniable, with hundreds of drug submissions to the FDA referencing AI solutions. But AI’s integration in trials must be balanced with careful considerations for a number of unique challenges, says M. Khair ElZarrad, director of the Center for Drug Evaluation and Research’s Office of Medical Policy.
Survey Shows Sites May Face Steep Learning Curve on ICH E6(R3)

May 17, 2024 | centerwatch.com | James Miessler

Adapting to the quality and risk management components embedded in the new ICH E6(R3) guidelines may present challenges for sponsors and providers, but it’s sites that may find the task particularly daunting, findings from an Avoca survey show. The 341-respondent survey conducted earlier this year focuses on sponsor, site and provider awareness of the new standards ICH E6(R3) presents and their perceived impact.
Warned for Unsecured Drug Storage, PI’s Corrective Plan Falls Short with FDA

May 10, 2024 | centerwatch.com | James Miessler

Precautions for securing a trial’s investigational drug(s) must be ironclad in the eyes of the FDA, and corrective and preventive actions enacted when these safeguards are absent or compromised must be just as rigorous, a recent FDA warning letter illustrates.
Mobile Trial Vans, Research Paramedics and More Featured in WCG Innovation Challenge

May 1, 2024 | centerwatch.com | James Miessler

Home » Mobile Trial Vans, Research Paramedics and More Featured in WCG Innovation Challenge The 2024 MAGI Clinical Research Conference in New Orleans played host to yet another exciting round of clinical trial innovation, with attendees voting on their favorite of five creative approaches in the WCG Innovation Challenge. Read on to learn more about this year’s winner as well as the four finalists.
Research Works’ Mobile Trial Van Drives Off with WCG Innovation Award

Apr 19, 2024 | centerwatch.com | James Miessler

A cargo van designed to serve as a fully functional mobile clinical trial site took the checkered flag as winner of this year’s WCG Innovation Challenge, presented last week at the 2024 MAGI Clinical Research Conference in New Orleans.