One of the biggest challenges in drug development is the long cycle, and the longest time in the entire development cycle is the clinical research phase. The industry is constantly looking for ways to accelerate clinical research.
At the beginning of this year, led by the Shanghai Municipal Commission of Economy and Information Technology, the Department of Science and Technology, and the Development Center of Shenkang Hospital, the Hospital-Industry ColLaborative Innovation Platform (HI-CLIP) was launched. "CLIP" also has the meaning of "paper clip", which is intended to connect the two ends of the enterprise and the hospital, and try to accelerate the process of clinical research from the perspective of information docking and process combing.
The developer interviewed Qian Biyun, director of the Clinical Research for Development Center (hereinafter referred to as "Shenkang Pro-Development Center") of Shanghai Shenkang Hospital Development Center, to gain an in-depth understanding of how the HI-CLIP platform works and how to change the process of connecting enterprises with hospitals, thereby improving the efficiency and shortening the time of clinical trials.
The change in the process from series to parallel
In the process of clinical trials, the very important feature of the HI-CLIP platform is to change the process of connecting enterprises with hospitals, changing from series to parallel.
In the traditional process, enterprises to carry out clinical research, especially multi-center clinical research, first of all, to find the main researchers and research units willing to undertake this project, after obtaining the ethical approval of the main center, and then contact other hospitals to complete the GCP project approval, ethics review and other processes of each hospital, which is the need for a "series" mode from a to b to c.
"In the traditional model, when enterprises find hospitals, the information of both sides may not be clear, and there is a lack of an adaptation process, and the success rate of clinical research and development may not be too high." Qian Biyun told the developer.
In the application scenario of HI-CLIP, the enterprise login platform will fill in the pre-set basic information template. The corresponding needs are fed back to Shenkang, and the clinical experts in the field make a preliminary judgment, mainly considering the innovation of the project, whether it will benefit patients, and whether the hospital intended by the enterprise has the feasibility of undertaking clinical trials.
After that, it will be assigned to the project management class of the corresponding professional field of the municipal hospital, and further online can be assigned to the hospital that has the ability to undertake the project in real time. After this intelligent matching process, it is equivalent to the synchronous coordination and clinical trial arrangement of a, b and c hospitals, that is, the "parallel" model.
According to Qian Biyun, before the HI-CLIP platform is officially launched, an important task is to build a supply database and demand database for both hospitals and enterprises.
For hospitals, a total of 1296 professional groups with drug clinical trial qualifications and medical device clinical trial qualifications will be structured. That is to say, according to the resources of the hospital, it is integrated into the corresponding database, including the hospital's research team, PI and nurses. For enterprises, a database is established according to the indications of the product, the product undertakes clinical trials, and the approval documents are obtained.
In addition, there are about ten project management classes in the operation of the platform, and each special class is led by experienced GCP project management experts in the corresponding field, responsible for managing clinical trial projects, which is equivalent to forming a structured database.
In addition, in order to match the company's product indications with the qualifications of hospital institutions, Shenkang Linxi Promotion Center and partners have developed an artificial intelligence model algorithm for natural language processing. These upfront efforts are made to prepare for a more precise match.
In fact, how different hospitals match this process during the operation of the HI-CLIP platform is a very critical issue.
In this regard, Qian Biyun said that since last year, the Shenkang Linshi Promotion Center has built a standardized system, from organizational structure, responsibility functions, project management, quality control to data management, there are unified standards. Such as the establishment of municipal hospital expert committee alliance, ethics committee alliance, in-hospital clinical research center (CRU) and so on. At present, under the management of Shenkang, the 36 municipal hospitals docked on the platform are basically promoted in the same mode and work under the same system. This is also a relatively unique model in the country.
Two examples of accelerated clinical trials
On the HI-CLIP platform, the docking of information more accurately and the unification and coordination of hospital processes can help improve the efficiency of clinical research and shorten the research cycle, especially the project establishment time.
It is understood that about 62 companies and 113 projects are currently running on the HI-CLIP platform. Shenkang Pro-Promotion Center preliminarily estimates that the time for clinical research can be saved by about 30%.
The following two examples illustrate the role of the platform in reducing clinical research time and improving efficiency.
A company conducting research and development of a new PD-1 drug, due to the impact of the epidemic, the recruitment of subjects was delayed, and it did not recruit enough cases in the two hospitals that had previously conducted clinical studies. After the company released the requirements on the HI-CLIP platform, it quickly matched to a hospital with more cases in this indication through Shenkang's medical federation big data platform and product development indications.
After that, Shen Kang quickly contacted the hospital, confirmed that the hospital's management and GCP institutions intended to undertake, and selected the appropriate research team to participate in this clinical trial, and then immediately contacted the company. On the HI-CLIP platform, both parties quickly agreed to eventually recruit a sufficient number of subjects.
There are similar examples in the field of medical devices. A company developed an innovative medical device project for the digestive tract, and sought clinical research cooperation hospitals in the Yangtze River Delta region in the early stage, but the progress has been relatively slow. After finding the HI-CLIP platform, it was quickly noticed by Director Zhang Li, head of GCP of Changhai Hospital, and Academician Li Zhaoshen, who is authoritative in the digestive tract, immediately recognized the innovation and feasibility of the project, and quickly undertook the project, greatly accelerating the docking speed of enterprises and hospitals.
Extend to the full chain of clinical research
From the current operation point of view, the HI-CLIP platform is currently focusing on the project to start this part of the work. However, Qian Biyun said that HI-CLIP is not only a one-way platform for enterprise matching research centers, but its subsequent development is more inclined to play a certain role in the whole chain of clinical research.
"Now we put more emphasis on clinical technology innovation, from the perspective of sources, a lot of good ideas come from doctors." Doctors actually carry out a lot of basic research and applied research, including clinically related disease mechanisms, and discovering potential drug development targets in the entire disease process. Many of the existing outputs and patents need to be translated and further studied. ”
Qian Biyun went on to say, "Research and development in the field of medical devices often has to be rapidly iterated, and if it is not closely connected with the clinic, the products that may be developed may not be suitable for the clinic." This requires doctors and enterprises to work together to develop and improve, step by step iteration. ”
Therefore, ShenKang also registered the clinicians' research results on the HI-CLIP platform. By filling out the form, researchers in hospitals can find matching companies to conduct research and collaborate together.
The HI-CLIP platform has also been developed on the patient side to increase participant engagement. There is not only the exchange of information to improve the efficiency of recruitment, but also the gradual inclusion of subjects in the design of some clinical studies.
In addition, shenkang pro-promotion center is also closely tracking the project process after the docking of enterprises and hospitals, and opening up the clinical research integration platform (Clinical Research Integrated Platform) system built by Shenkang to promote the quality of clinical research in municipal hospitals, so as to extend the docking of clinical trials to the speed and quality of the whole chain. At the same time, the continuous optimization of hi-CLIP's operation and operation process is also in Shenkang's plan.
Editor| Yao Jia layout| Zhang Yue
Issue 1429