Value Pharmaceutical Services Co., Ltd
Outside:
The second day meeting of the Fourth China Forum on Innovative Drugs is still brilliant and full of seats. Today's forum is divided into four parts, namely, R & D and clinical study of new drugs of traditional Chinese medicine (sub-forum 1), risk and quality management of clinical trials (sub-forum 2), pharmacoeconomics and medical insurance forum (sub-forum 3) and biomedical frontier forum (sub-forum 4). We also bring you live broadcast reports on the speech content of speakers in part 2 of the sub-forum:
Director Yan Zhao of Chinese Anti-Cancer Association shared with the participants "How to prevent safety risks in clinical trials of anticancer drugs". He first pointed out that domestic Biotech has become a key engine to promote innovation, obtaining 45% of clinical batches (CTA) between 2017 and 2019; at the same time, the research and development of cancer drugs has comprehensively entered the era of indications + targeted drugs. Next, he introduced in detail the safety risk consideration in the design of phase I-III clinical trials, the evaluation criteria based on good risk-benefit ratio, the collection and evaluation of adverse events (AEs), and the reporting of safety events.
Dr. Liying Sun, Chief Scientist of Haijinge Pharmaceutical, gave a report entitled "Key Role of Medical Top Level Design in Clinical Research of New Drugs". Clinical medicine is the most important factor affecting the marketing of innovative drugs, and good top-level design of medicine is the key to clinical medicine. Elements that affect the top-level design include familiarity with guidelines, a profound understanding of regulatory review, understanding of the perceptions of reviewers and scientists in different dimensions, familiarity with regulatory monitoring, and familiarity with the definition of DLT-MTD for side effects. At the same time, attention should also be paid to the cooperation of different specialties in the top-level design of medicine.
Wang Rui, a researcher from the General Hospital of the Chinese People's Liberation Army, introduced in detail the requirements of the new version of GCP for subject safety protection and trial risk prevention and control focusing on the current situation of new drug R & D and clinical trials in China, the necessity of safety evaluation in clinical trials of innovative drugs and the key points of risk management in clinical trials of innovative drugs.
Study module:
Dr. Zhenyu Yang, Chief Scientist of Yeedozencom Biostatistics, brought about the sharing of "New ideas for new drug R & D and clinical application under real-world evidence". Dr. Yang Zhenyu first introduced the background of real world research development at home and abroad to the participants and explained the meaning of the three concepts of "real world data", "real world evidence" and "real world research". Next, he introduced the participants in detail to their own practical work the real-world evidence to support drug regulatory decisions in the registration and marketing of new drugs, changes in the package inserts of marketed drugs, and the application of fluticasone propionate inhalation aerosol, ibuprofen injection and other chemicals and traditional Chinese medicines. Finally, Dr. Zhenyu Yang shared reflections on real-world data, real-world evidence, and the use of real-world research for registration decisions.
Professor Yao Chen from Peking University Clinical Research Institute gave a report entitled "How to play the role of statistics in the quality control of clinical trials". He pointed out that attaching importance to the design of research protocols and strictly following protocols are important means to reduce systematic errors. Recording and traceability of data and data files is the core of quality management of clinical trial data. Only by providing evidence of the integrity of the quality assurance of the trial process can drug safety and effectiveness be convincingly based on the veritable cornerstone of scientificity, correctness, and credibility.
Round table:
Dr. Zhenyu Yang, Chief Scientist of Biostatistics, Yeedozencom, participated in the round-table discussion and discussed the generation of various risks and corresponding avoidance strategies in clinical trials from the statistical point of view.
