ABSTRACT
Overall survival (OS) is considered the standard clinical endpoint to support effectiveness claims in new drug applications globally, particularly for lethal conditions such as cancer. However, the source and reliability of OS in the setting of clinical trials have seldom been doubted and discussed. This study first raised the common issue that data integrity and reliability are doubtful when we collect OS information or other time-to-event endpoints based solely on simple follow-up records by investigators without supporting material, especially since the 2019 COVID-19 pandemic. Then, two rounds of discussions with 30 Chinese experts were held and 12 potential source scenarios of three methods for obtaining the time of death of participants, including death certificate, death record and follow-up record, were sorted out and analysed. With a comprehensive assessment of the 12 scenarios by legitimacy, data reliability, data acquisition efficiency, difficulty of data acquisition, and coverage of participants, both short-term and long-term recommended sources, overall strategies and detailed measures for improving the integrity and reliability of death date are presented. In the short term, we suggest integrated sources such as public security systems made available to drug inspection centres appropriately as soon as possible to strengthen supervision. Death certificates provided by participants' family members and detailed standard follow-up records are recommended to investigators as the two channels of mutual compensation, and the acquisition of supporting materials is encouraged as long as it is not prohibited legally. Moreover, we expect that the sharing of electronic medical records and the legal disclosure of death records in established health registries can be realized with the joint efforts of the whole industry in the long-term. The above proposed solutions are mainly based on the context of China and can also provide reference for other countries in the world. © 2022 The Authors
ABSTRACT
Messenger ribonucleic acid (mRNA) vaccine is characteristic of subunit vaccines and live attenuated vectors. It can simultaneously induce humoral and cellular immunity, and has the advantage of easy to produce on a large scale. Therefore, great application prospects are seen in the field of infectious diseases and the treatment of major diseases. In the field of biomedicine, mRNA vaccine has been deeply cultivated for decades. With the outbreak of the COVID-19 epidemic and the pandemic, the process of listing mRNA vaccines has been greatly accelerated and promoted. The COVID-19 mRNA vaccines, with lipid nanoparticles (LNPs) as the carrier which deliver the mRNA encoding the COVID-19 spike protein antigen information to host cells, were successfully launched, showing good safety and efficacy. Meanwhile, the development of the delivery system, as the key technology of mRNA vaccines, has also become a "battlefield" for the development of mRNA technology. Various delivery technologies, including LNPs, are being actively developed in China and abroad. Safe and effective delivery with independent intellectual property rights will become the key to promote the marketing of mRNA products, which will obtain benefits in the future. This article reviews the mRNA vaccine delivery system and research progress. Copyright © 2022, Chinese Journal of New Drugs Co. Ltd. All right reserved.
ABSTRACT
In the face of the COVID-19 pandemic and the global sales trend of fruits, automatic ripeness grading of fruits is of great significance for enterprises, reducing labor-related costs and precise resource regulation of the fruit industry chain. The wrong ripeness grading may lead to inferior products entering the market chain and resulting in over ripeness, spoilage, quality degradation, and economic loss issues. Traditional manual grading and machine vision-enabled grading methods are facing a series of challenges, such as low efficiency, inconsistent grading standards, and vulnerability to environmental interferences. Therefore, a flexible sensing enabled intelligent manipulator system (FSIMS) is developed for efficient, automatic and accurate ripeness grading of avocados, one of the most popular and economically valuable fruits in the world. When avocados of different ripeness level are gripping, the flexible sensing units attached in the clamps can sense the firmness of the contact points and feedback different pressure values of the system, which could accurately determine four ripeness levels of avocados. Compared with traditional manual or machine vision enabled fruit ripeness grading methods, the designed FSIMS could achieve better grading effect (97.5% accuracy), and the system also has a faster grading speed (the fast-grading speed could reach 1.3 s/time) and high environmental robustness. The application of FSIMS could effectively reduce the waste of avocados in the market supply chain, greatly alleviating the labor-intensive and inefficiency problems of the fruits ripeness grading, thereby promoting the more sustainable and cleaner production of the avocado industry.