In the business of pharmaceutical and MedTech clinical development, the significance of robust data cannot be overstated. It serves as the cornerstone for informed decision-making and cultivates an environment where innovation thrives. However, when confronted with the task of comparing ethnicity data across diverse countries, a myriad of challenges and intricacies surface, warranting a thorough…
Stacy Weil
Clinical Development
4 Steps to Implementing DEI in Clinical Trial Design and Patient Recruitment
Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments, click here. In today’s clinical research environment, sponsors face the challenge of comprehensively incorporating DEI…
Clinical Development
FDA’s Push for DEI in Clinical Trials: What Sponsors Need to Know in 2024
In the ever-evolving field of global clinical research, the integration of diversity, equity, and inclusion (DEI) has become a pivotal focus, especially considering recent FDA initiatives and legislative changes. The U.S. Food and Drug Administration’s (FDA) ongoing efforts, coupled with the enforcement of the DEPICT Act and impending final regulatory guidance, highlight the urgency and…
Each year, nearly 85 million Americans see a physician for at least one skin disease, with $75 billion in direct costs to the U.S. healthcare system.1 While the FDA has approved more than 110 dermatology drugs, these treatments address only about 30 indications, leaving the vast majority of known skin conditions unaddressed. In recent years,…
In a survey conducted by Informa Pharma Intelligence on behalf of Oracle Health Sciences, 76 percent of respondents indicated that the pandemic hastened their adoption of decentralized clinical trial (DCT) approaches. While the shift to DCTs is well underway, concerns remain around patient monitoring and engagement and data reliability and quality. In particular, nearly half…
Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. In a recent survey commissioned by Oracle Health Sciences, more than 75 percent of industry respondents indicated that limitations in patients’ ability to attend on-site visits sped up their adoption of decentralized…
Real-World & Late Phase
Entering a New Clinical Phase of Non-Traditional Data Sources
This is part two of a two-part series, you can read part one here. In this post, we will cover non-traditional data points, their use in randomized control trials (RCTs), and how they contribute to a successful data strategy. The rise of real-world data and real-world evidence Non-traditional data points, in particular real-world data (RWD)…
Real-World & Late Phase
Can Your Clinical Data Strategy Keep Pace?
Here we cover the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face of a changing clinical research environment.