In the European Union, data on racial or ethnic origin are classified as a “special category” under Article 9 of the GDPR, which generally prohibits their processing unless specific conditions are met, such as explicit consent or substantial public interest safeguards. As a result, several EU countries, including France, Germany, Denmark, and Sweden, do not… Continue reading Do We Still Need Country-Specific Data?
Category: Clinical Research
Operational Challenges of Conducting RWD Studies in China
by Monique Samuels The use of real-world data (RWD) is growing across the industry and is increasingly encouraged by regulatory agencies worldwide. RWD can provide insights into patient populations, treatment patterns, and outcomes outside of controlled clinical trials. China, with its large and diverse patient population, offers an important opportunity for global evidence… Continue reading Operational Challenges of Conducting RWD Studies in China
Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
The approval of eflornithine (brand name Iwilfin) for pediatric high-risk neuroblastoma offers an interesting example of how the FDA evaluates single-arm trials supported by external control arms (ECAs). External controls are increasingly common in oncology and rare disease drug development, but they remain a source of careful regulatory scrutiny. In this case, the FDA’s assessment… Continue reading Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
The Expanding Role of Epidemiology in Modern Real-World Data Research
When observational retrospective research began to be used more systematically more than twenty years ago, the real-world data (RWD) landscape was relatively simpler. Not necessarily easier, but simpler. A limited number of large administrative and clinical databases dominated the field. Claims databases, national registries and a handful of electronic medical record (EMR) sources were directing… Continue reading The Expanding Role of Epidemiology in Modern Real-World Data Research
EHDS Section 60: The Illusion of Neutral Data Sharing?
Reading the EHDS regulation carefully, and in particular Section 60, leaves a sense of discomfort that is not really about legal drafting, but about how knowledge is produced and legitimized. The text is cautious, layered with safeguards, and repeatedly reassures the reader that intellectual property, trade secrets, and commercial confidentiality remain protected. And yet, between… Continue reading EHDS Section 60: The Illusion of Neutral Data Sharing?