Real-world research (RWE) is increasing in drug review and decision-making

Real-world research (RWE) is increasing in drug review and decision-making

In recent years, the application of real-world research (RWE) in drug review and decision-making has increased significantly, becoming a hot topic in the pharmaceutical field. With the advancement of big data technology and the improvement of regulatory policies, RWE is gradually transforming from an auxiliary tool to an important means to support the management of the entire life cycle of drugs. This article will analyze the latest progress of RWE in drug review from three aspects: policy trends, industry trends and actual cases, combined with structured data.

1. Policy Trends: Global regulators accelerate their embrace of RWE

In the past 10 days, the US FDA, European EMA and China NMPA have all issued new policies or guidelines related to RWE. Here are some key contents:

2. Industry trend: RWE application scenarios continue to expand

According to recent industry reports and conference sharing, RWE's application has expanded from traditional post-market research to the following areas:

3. Typical cases: RWE helps innovative drugs to be approved at a faster pace

A recent case worth noting is that a PD-1 inhibitor has been approved for new indications in China through the RWE path:

In this case, the company shortened the time required for traditional clinical trials by about 40% by analyzing real-world treatment effect data, while reducing R&D costs. Regulators recognize the value of supplementary evidence for RWE in specific populations.

4. Challenges and prospects

Although RWE has broad application prospects, it still faces challenges such as data quality and standardization of analysis methods. The future needs:

1. Establish a unified RWD acquisition and processing standard
2. Develop more advanced causal inference methods
3. Strengthen communication and cooperation between regulatory authorities and the industry

With the advancement of technology and the accumulation of experience, RWE is expected to play a more important role in the management of drugs throughout the life cycle and bring safer and more effective treatment plans to patients.