Rare diseases create a unique challenge for evidence generation. The number of patients is often small, diseases are heterogeneous, and clinical knowledge can be limited. Traditional clinical trials may struggle to recruit enough participants, follow patients for a sufficient period of time, or capture the complexity of disease progression in real life. For these… Continue reading Rare Disease Registries: How Much Data Is Enough? Balancing Scientific Rigor with Clinical Reality
Tag: Clinical Research
From Wearables to Real-World Evidence: Are We Ready for Consumer-Generated Health Data?
The recent partnership between Oura and Eli Lilly has raised considerable attention across the healthcare industry. At first glance, it looks like another collaboration between a technology company and a pharmaceutical manufacturer. However, looking deeper, it signals a broader transformation that could introduce new aspects on how patients are monitored throughout their treatment journey. … Continue reading From Wearables to Real-World Evidence: Are We Ready for Consumer-Generated Health Data?
The Practical Applications of AI in Real-World Evidence Studies
Artificial intelligence has become a very frequently discussed topic also in real-world evidence (RWE) research, registries, and clinical data science. Conferences, publications, and industry reports routinely highlight AI as a transformative force capable of accelerating evidence generation, improving data quality, and expanding the utility of healthcare data. However, much of this discussion remains high… Continue reading The Practical Applications of AI in Real-World Evidence Studies
Do We Still Need Country-Specific Data?
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?
Do Pharma Still Need Large CROs for RWD Studies?
In the traditional model of real-world evidence (RWE) generation, sponsors relied almost automatically on contract research organizations (CROs) to manage observational studies end to end. That model made sense when data were fragmented, technology limited, and sponsors lacked internal capacity. Today, the landscape is very different. Data networks are richer, analytical platforms are significantly more… Continue reading Do Pharma Still Need Large CROs for RWD Studies?