FDA intends to replace traditional clinical trials with real-world research
Some experts said that Real-World Study (RWS) will be the trend of future research. Compared with Randomized Controlled Trial (RCT), RWS has a broader scope and is more representative. Sexuality can truly reflect the research situation.
RWS stands for future research trends?
RWS is a clinical trial that originated in practicality and belongs to the category of drug epidemiology. It is a non-random, open, placebo-free study based on clinically realistic conditions, so the results are highly externally valid. At present, RWS has received much attention in the medical field, and some disciplines have established relatively complete observation queues, registration and management databases.
RWS is a patient-centered outcome study with the following characteristics: the location of the study and the intervention conditions are real clinical practice environments; the choice of subjects is generally without special restrictions; the interventions are also clinically practical and can be Patients and physicians communicate to change intervention methods. There is no blinding in the real world research environment, no randomized controls, no placebo treatment, and the conclusions of the study can be directly derived from clinical practice.
In fact, the milestones of China's clinical research are also derived from real-world data research, from the China Chronic Disease Prospective Study (KSCDC) launched in 2004 to the 2015 China Cancer Statistics to the World Academic Journal CA. (IF: 144.8) These are all typical examples of real-world research, and along with these studies have produced a large number of high-level research results.
Real-world research can not only reduce the limitations of traditional research, but also reflect the clinical efficacy of therapeutic drugs in the real world, providing an objective basis for clinical selection of new drugs and new devices. Through real-world data evidence, we can fully understand the gap between guidelines and practice, provide reference for the development and specification of guidelines, and balance clinical efficacy and cost-effectiveness.
RWS also has "environment"
Although real-world research has so many benefits, there are some problems: real-world research is generally not drug-centered, but patient-centered, and whether pharmaceutical companies are willing to invest is one of the problems; real-world research requires a large number of research samples. Even multi-center events, data collection is difficult and the workload is huge; data heterogeneity is strong, and the requirements for statistical methods are higher than traditional research; mostly for retrospective analysis or post-mortem analysis, the level of research evidence is challenged. Faced with so many problems, RWS seems to be struggling, and these urgent problems need to be solved by latecomers to promote the development of RWS.
Just last month, the US Congress published the final version of the 21st Century Cures Act (hereinafter referred to as the Act) on the official website, from the proposal to the revision, and then to the final version. After more than two years, the bill to promote the development of biomedical innovation, disease treatment and health in the next 10 years or more has finally taken root.
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