In the real world, speed is one crucial factor in the battle of saving more lives. Real World Data (RWD) is highly anticipated to expedite the review process of drugs and medical devices.
Random controlled trials (RCTs) are currently the most important HTA tool for determining whether a drug is effective. The results of RTCs could provide the reviewers with sufficient insight; however, the results cannot guarantee that a drug performs as well in real world as under the trial environment. Furthermore, RTCs are limited in predicting the long term efficacy and safety of a drug. Hence, it is foreseeable that Real World Evidence (RWE) will have an important part of the medical decision-making process in the future.
Past experiences show that even the best designed RCTs are not able to fully imitate the real world conditions. After the 21st Century Cures Act came into effect in December 2016, the US FDA has drafted relevant guidelines to usher in the era of holistic and patient-centered treatments, hoping to provide drugs and medical devices which are safe and truly reflect the treatment situations.
RWE refers to the evidences and data collected outside the context of RCTs. It can be the electronic health records kept by hospitals and the health authorities, or the data collected directly from patients via home monitoring devices, wearable devices, etc. The data is collected and analysed so as to depict the real treatment situations and patient’s real-life conditions. Such data will then be used to support the medical decisions.
Though drug companies may need to spend more money in monitoring and tracking the treatment result of a drug which is approved and launched according to the RWE-related pathway, in general, it will lower the overall costs and lower the mortality rate. RWE has already started a worldwide trend in the past 4 years and could change the future healthcare ecosystem.
RWE will change our concept of healthcare, help doctors to make clinical treatment decisions, translate certain genetic data into practical applications, expedite new treatment methods and ultimately change the healthcare ecosystem.
For example, the reason why the vaccines for COVID 19 could be on the market in such a short time is largely because of the use of RWE. If the healthcare industry and the IT industry could work together, it will accelerate the development of new drugs and new medical devices. RWE opens up more possibilities for future medical treatment.
【2021-10-11 / United Daily】
