A troubling trend is being seen in clinical research: sponsors frequently overestimate their oncology trial budgets while underestimating budgets in other areas, creating challenges for sites trying to prepare for and manage trials. Read More
Sponsors and CROs are shifting away from the traditional wide-net approach and focusing more on investing in fewer numbers of sites. Should this trend pick up speed as some project, sites may need to adapt best practices, embrace sponsor-driven changes and keenly address their shortcomings to remain competitive. Read More
A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or investigational device exemption (IDE) applications. Read More
A new draft guidance from the European Medicines Agency (EMA) defines requirements for redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS). Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted by the Alliance for a Stronger FDA. Read More
Data from adult trials of a particular drug can be used to evaluate the safety of the drug in a pediatric population, according to a draft guideline released for public comment by the International Council on Harmonization (ICH) and the European Medicines Agency (EMA). Read More
To expand the field of gene therapy, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), believes that the current clinical development framework is in need of rethinking in terms of trial design, endpoints, communication and other areas. Read More
An international guideline focused on building quality into clinical trials is now official FDA guidance. The agency has published the International Council for Harmonization’s (ICH) E8(R1) — General Considerations for Clinical Studies as a final guidance, signaling its support for the “quality by design” concept. Read More
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on drug and device development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More
The European Medicines Agency (EMA) has called on sponsors conducting trials in Ukraine to address disruptions related to the current conflict by applying strategies used to address the pandemic where and when they can. Read More
