Research Report: four innovative experimental designs can increase the probability of drug listing by 10% - 21%

On October 16, parexel International Corporation, a biopharmaceutical service provider, and the economist think tank jointly released the Research Report "innovation is imperative: the future of drug research and development" in China For the first time, the report quantifies the positive impact of key innovations on key success factors in drug development According to the report, the four innovative areas of adaptability test, patient-centered test, precision medicine test and real world data test have a positive impact on the clinical trial process, marketing probability and inclusion of drugs in the formulary - the use of these innovations can increase the marketing probability of drugs by 10% - 21%; in important treatment areas (Neurology, oncology and rare diseases), Drugs developed with these innovations are more likely to reach the listing standard, with an average increase of 16% in the listing probability Among them, drug development in oncology is the most affected by these innovations, with a 33% increase in the listing probability of drugs in this field In recent years, drug development is becoming more and more difficult and expensive The failure rate of drug development can be as high as 90% The average time for each drug to go on the market is about 12 years From 2012 to 2016, the cost of drug research and development has doubled In order to explore the most promising innovation in drug development and market access, JINGDING pharmaceutical and the economist think tank launched a five-year (2012-2017) research project to analyze the impact of innovation on the main success factors of drug development The project examined clinical trial data and other data from four major markets - China, the United States, the European Union and Japan These geographic areas are the main targets of many drug developers At the same time, through the interdisciplinary expert group discussion, the project has identified four innovative areas that have the most positive impact on the sustainability and beneficial improvement of drug development - adaptability test, patient-centered test, precision medicine test, real world data test, and conducted quantitative research The report points out that the innovative trial design has a great positive impact on improving the probability of drug listing and clinical trial efficiency, and is gradually accepted by regulatory agencies, especially in China, the second largest pharmaceutical market in the world, the strength and speed of promoting innovation are increasing In 2016, the former China food and Drug Administration (CFDA) issued the notice on the issuance of Biostatistics guidelines for drug clinical trials, which elaborated and guided the design of adaptive trials in detail In the same year, the 13th five year plan of the state was released, and precision medicine was included as a development focus, which became a national strategy Real world data is also increasingly accepted in China, where the number of disease registries and management databases has grown rapidly since 2008 In addition, in 2015, the former CFDA launched the Chinese hospital pharmacovigilance system, which covers the electronic medical records and medical insurance claim data of 300 hospitals, making up for the inadequacy of the existing passive drug safety testing of the national ADR monitoring center with real world data Although data evaluation proves that innovation has a great positive effect on drug development, due to some institutional and cultural barriers, the actual adoption rate of these innovations is very low: the adoption rate of adaptive test and real world data test is less than 1%, the adoption rate of patient-centered test is 5.2%, and the adoption rate of precision medicine test is 13.7% In terms of the total number of experiments, the EU and the US account for the largest proportion in each innovation field, 33-34% and 36-46% respectively, while China accounts for only 1-6%, far lower than the developed markets in Europe and the US In China, improving the level of clinical research is also an urgent problem According to a research report jointly released by rdpac and six other industry and academic associations in 2017, the development of clinical research in China has lagged behind other links of pharmaceutical innovation industry chain, and the imbalance between the demand for clinical research and clinical research resources is increasing If the capacity and resources of clinical research cannot be solved in time, the development process of China's innovative drug industry will be delayed for at least five to ten years Jamie MacDonald, CEO of JINGDING pharmaceutical, said: "although our research shows that the current adoption rate of these four innovations in the world is very low, they have a huge influence in helping to improve the efficiency, productivity and sustainability of drug development As the second largest pharmaceutical market in the world, China has great potential to lead the innovation and development of global pharmaceutical development " As a biopharmaceutical service innovation enterprise, JINGDING pharmaceutical is committed to promoting the implementation of innovation in China and around the world Its multiple projects focus on solving the challenges faced by global drug development, promoting the development of life science ecosystem, so as to provide faster and more efficient treatment for patients It includes the establishment of patient innovation center to provide guidance for pharmaceutical enterprises to improve the work efficiency and success rate in various fields of biopharmaceutical development; the establishment of technology development alliance with Microsoft, aiming to improve the efficiency and success rate of biopharmaceutical development through Microsoft cloud Azure) provided technical support to promote the innovation and development of life science industry; also reached cooperation with datavant, a healthcare technology company, to strengthen its clinical research design and operation level, as well as real world research capabilities.