How to obtain clinical trial information opportunities for new drugs and new devices? Ruijin Hospital opens two outpatient clinics to light up "lights" for patients

Release time:May 20, 2024 14:14 PM

“For desperate patients with advanced cancer, trying new drugs as early as possible is undoubtedly a light in the darkness.”

Shen Baiyong, deputy director of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, said so. In recent years, the public's understanding of clinical trials of new drugs is changing: many patients will take the initiative to ask doctors whether there are new clinical trials to participate in, and more and more patients understand that clinical research is based on full patient knowledge and ethics. Medical exploration under protection and active participation in clinical research will become the fastest and most direct beneficiaries of new drugs and treatments, and this is the meaning of medical clinical trials.

Today is the 20th International Clinical Trials Day. This year’s theme is “Guard Health, Light Up Hope.” In order to further promote the development of clinical research, Ruijin Hospital today established a clinical research multidisciplinary consultation clinic and a Ruijin-Hainan licensed new drug and new device consultation clinic. The establishment of these two clinics will provide patients with more professional and comprehensive clinical trial consulting services, helping patients better understand and participate in clinical trials.

As early as 1997, Ruijin Hospital obtained the qualification of a national clinical drug trial base and subsequently expanded into the field of medical devices. Today, the institution has 35 drug clinical trial majors and 43 medical device clinical trial majors. Nearly a hundred professors lead research and carry out the use of new drugs and new devices. The test areas cover digestion, cardiovascular, endocrinology, blood, burns, orthopedics, Medical imaging, respiratory, infection, nephrology, neurology, urology, skin, oncology, obstetrics and gynecology, anesthesia, traditional Chinese medicine orthopedics, general surgery, pediatrics, critical care, thoracic surgery, ophthalmology and other majors.

"In addition to treating patients, Ruijin Hospital also has an important mission, which is clinical research." Shen Baiyong said that Ruijin Hospital undertakes about 200 to 300 registered clinical research projects and nearly 500 clinical research projects independently initiated by researchers every year. Research, the scale ranks first in the national medical system.

Today, this platform is even closer to patients. "Through the clinical trial clinic, Ruijin can help patients 'find drugs' around the world." Shen Baiyong explained that for new drugs that have not yet been launched in the country, patients can consult a doctor through this clinic. After a comprehensive evaluation, Ruijin Hospital will coordinate Introduce the required drugs to the Hainan branch and provide treatment to patients through clinical trial procedures.

“Generally speaking, it often takes 3 to 5 years for a drug to be launched from clinical trials to approval. However, with the help of the Ruijin Hainan Hospital platform, the waiting period is greatly shortened, and patients can use the most cutting-edge medicines without having to travel overseas. Jin Jiabin, deputy director of Hainan Branch, said that as an exclusive domestic pilot, Ruijin Hainan Hospital in Boao Lecheng actively promotes the application of new drugs and new devices, so that new drugs and new devices that have not yet been approved in China can pass clinical trials. Research methods are used by patients as early as possible.

On June 22, 2022, 10-year-old girl Zheng Ni successfully received vorsolide injection treatment at Ruijin Hainan Hospital. Vorsolitide is currently the only drug approved in the world for children with achondroplasia. It is also the first new drug project in the country to be launched by Ruijin Hainan Hospital.

Since then, many patients with Alzheimer's disease, ALS, hypertension, allergic rhinitis, etc. have also used new drugs in Hainan's "zero time difference". In May last year, the pancreatic surgery team successfully performed a single-hole da Vinci robotic surgery at Ruijin Hainan Hospital. 74-year-old Grandma Wang became the first clinical case in the world. At the same time, relevant data were also provided to the U.S. Food and Drug Administration to apply for a pancreatic surgery license. certificate.

Since the "14th Five-Year Plan", the drug and medical device clinical trial institution of Ruijin Hospital has undertaken 498 clinical evaluations of new drugs and 93 clinical trials of medical devices, including 143 leading projects and 172 international multi-center projects, successfully assisting the country's first cell therapy Products Akilenza Injection, "Zhangjiang R&D and Made in Shanghai" independently developed oral Class 1 innovative drug deuterated remidevir hydrobromide tablets, my country's first Class 1.1 natural drug new drug Xiangleitang Foot Ointment, and the first domestically produced proton therapy device The system and the country’s first innovative pharmaceutical device using deep learning technology software were approved for marketing.

At the same time, Ruijin Hospital is also actively exploring the field of clinical research initiated by researchers. In 2017, the Ruijin Hospital Clinical Research Center was established as a public service platform for clinical medical research in the hospital to provide researchers with one-stop technical support, covering research plan design. , data management, statistical analysis, training, etc., and also undertakes the project review and management tasks of IIT research. The platform provides support for Academician Ning Guang’s BPROAD research, Professor Zhao Qiang’s expanded research published in the Journal of the American Medical Association, and major clinical research projects in the second round of Senkon’s three-year action plan; participating in the design has great scientific significance and application prospects. Clinical research plans, such as Professor Shen Bai’s research on treating pancreatic cancer with mRNA vaccine. During the COVID-19 epidemic, the center invested heavily in innovative IIT research such as hydroxychloroquine and VV116, and relevant results were published in the British Medical Journal and the New England Journal of Medicine.

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