Results for 'diagnostic'
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
Jaques van Heerden, MD, Mohamed Zaghloul, MD, Anouk Neven, MSc, Teresa de Rojas, MD, PhD, Jennifer Geel, MD, Catherine Patte, MD, Joyce Balagadde-Kambugu, MD, Peter Hesseling, MD, Francine Tchintseme, MD, Eric Bouffet, MD, and Laila Hessissen, MD
Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives
pediatric oncology, clinical trials, research, Africa, collaborative research
Current childhood cancer survival rates in African countries range from 8.1% to 30.3%. The review focuses on pediatric oncology trials in Africa, highlighting challenges and suggesting research collaboration opportunities. Data were collected from the SIOP global mapping survey, ClinicalT…
Aug 7th • 10 mins read
Eric Q. Konnick
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
Oncology, Regulation, Testing, LDTs, FDA, CLIA, CMS
The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions. Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests. There are ongoing …
May 22nd • 8 mins read
Peter Varnai, Anoushka Davé, Kristine Farla, Anke Nooijen, Liana Petrosova
The Evidence REVEAL Study: Exploring the Use of Real-World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry
real world evidence, CCT, complex clinical trial
The European Medicines Agency (EMA) should develop an RWE framework for premarketing authorization in Europe. EMA and the European Medicines Regulatory Network (EMRN) could lead the development of RWE standards in the EU and beyond. Joint demonstration projects by the European Commission and ind…
Nov 20th • 10 mins read