Oncology trials often lead the research innovation pack, from deploying diverse data sources to using novel recruitment methods to embracing new trial designs. While some advances are specific to cancer research, researchers in all fields can look to oncology studies to improve their own trials, especially when it comes to patient centricity and harnessing the power of new tools and strategies.
Read More
Clinical trial professionals and academic organizations have long been cautious about the safety and legal liability of including pregnant or lactating participants in studies. But a recent report from the National Academies of Sciences, Engineering and Medicine (NASEM) finds limited evidence to support those fears.1 The report also warns that the lack of evidence available to these patients and their doctors about using a drug or vaccine poses greater potential harm than including them in research would.
Read More
The FDA’s guidance on the quantity of bioavailability (BA) and bioequivalence (BE) testing samples to be retained by NDA applicants and contract research organizations (CRO) contains both draft and final language focusing on both the test article and reference standard.
Read More
As part of its Accelerating Clinical Trials in the EU (ACT EU) initiative, the European Medicines Agency (EMA) has established a collaborative, multistakeholder platform to facilitate discussion on comprehensively improving clinical trials in the EU.
Read More
A new CDER subcenter is looking for drug developers with specific in-process studies for a demonstration program intended to boost innovation in clinical trial design.
Read More
The FDA’s Center for Device and Radiological Health (CDRH) has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions and expansion of decentralized trials.
Read More
The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance advising sponsors to include both clinical and preclinical information in the investigator’s brochure when applying for medical device trial authorization.
Read More
The FDA and NIH are asking stakeholders for support in developing a glossary of terms related to clinical trial innovation, especially terms involving use of real-world data (RWD) and real-world evidence (RWE).
Read More