Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction. This “digital awakening” offers consumer-centric products and service innovations that stand to transform not just the products that are built, but how and for whom they are built.
Like most instances of adopting new ideas and government programs, few people in drug development have a firm grasp upon and truly understand the FDA’s real-world evidence (RWE) program and the impact it will have on clinical research and trials. This article will guide you through the program and what it means for drug developers and explain the potential that real-world data (RWD) offers in developing RWE to significantly and safely accelerate the drug approval process.
Trends related to oncology R&D pipelines translate simultaneously into an opportunity and competition for pharma companies, depending on how the organization is positioned. Pharma today needs to compete not only on the basis of the strength of R&D pipelines and treatment portfolios, but also on the outcomes they produce and the ability to demonstrate evidence in a prompt and appropriate manner.