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:
| mechanism | Policy/Guidelines Name | Release time | Main content |
|---|---|---|---|
| US FDA | Real-World Evidence Program Annual Report 2023 | 2023-10-15 | Summarize the application cases of RWE in 2022 in 24 new drug approvals |
| European EMA | Guidelines for the Quality Assessment of Real-World Data | 2023-10-18 | Clarify compliance standards for RWD data sources |
| China NMPA | "Real-world Evidence Supports Guiding Principles for Drug Development (Draft for Comments)" | 2023-10-20 | The first time to submit RWE can be used to support registration application for innovative Chinese medicine drugs |
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:
| Application scenarios | Percentage (2023) | Annual growth rate |
|---|---|---|
| Support new drug approval | 32% | +45% |
| Indications extension | 28% | +33% |
| Drug safety monitoring | 25% | +22% |
| Medical insurance decision-making support | 15% | +68% |
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:
| Drug name | enterprise | Indications | RWE data source | Approval time |
|---|---|---|---|---|
| XX monoclonal antibody | Company A | Second-line treatment of gastric cancer | Electronic medical record data of 5 Grade A hospitals | 2023-10-12 |
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.
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