The stem cell clinical trials management approach (trial) "(draft)

The ministry of health of the People's Republic of China: www.moh.gov.cn

        To regulate stem cell clinical trials process, ensure scientific research results, protect the lawful rights and interests of the subjects and life health and safety, in 2012, the ministry of health and state food and drug administration clinical stem cell research and application specification rectification work leading group organization expert committee of research made the "stem cell clinical trials management method (trial)" (hereinafter referred to as the "management method research"), through repeated discussion, modification, has form the draft, and in March 2013 for advice throughout the country. Interpretation will now about the problem are as follows:

        A, why want to formulate measures for the administration of the research?

        At present, in stem cell research in our country, the treatment of some refractory diseases has carried on the beneficial exploration, some research has made gratifying progress, won the domestic and foreign counterparts. But some studies have not been fully preclinical safety and efficacy studies, there are organizations that stem cell products and preparation area is difficult to meet the requirements of GMP, some research objectives are not clear, clinical research and clinical application of confusion. Not only wastes the resources, but also to the patient and the health technical regulation poses a potential risk. Therefore, urgent need to standardize management and formulate the corresponding stem cell clinical research technical standards.

        2, follow the basic principles of is what?

        One is research on stem cell clinical trials should be related to the oversight of the department of management. As stem cell clinical trials research involving human subjects, must obtain a pre-clinical evidence of sufficient to perform the necessary of the declaration, review procedures, and in the related management departments for the record, to accept the regulation on the implementation of the project.

        Secondly, research on stem cell clinical trials shall abide by the quality control standard for clinical trials and other documents required. Stem cell therapy as a new method, although have some different from the existing drugs or characteristics of the traditional technology, but its clinical research and drug clinical trials, must follow the drug clinical trial and the quality control standard for the basic principle, ensure reliable research results.

        Three is to carry out the stem cell clinical research must conform to the code of ethics. Stem cell clinical trials shall abide by the code of ethics, in line with the "involves people of biomedical research ethics review method (try out)" and "human embryonic stem cell research ethics guidelines" requirements, ensure that the subjects' rights are fully respected and protected.

                Four is stem cell products preparation site must meet the requirements of GMP. Stem cell products preparation is a key link in the process of quality control stem cell clinical trials, in accordance with internationally accepted practices, stem cell products preparation should be done in GMP conditions of site.

Five is stem cell clinical trials management must be took into account the characteristics of stem cells. Stem cells to treat the many indications of how is the lack of clinical treatments, and lower incidence of disease, and even some rare disorders, clinical trials need to the number of cases of every period of be practical and realistic consideration according to statistical requirements.

        3, what is the main content of the file?

        "Stem cell clinical trials management method (trial)" article thirty-eighth seven chapters and two attachments, including the general provisions, declaration and registration, clinical research, donors and the subjects' rights and interests safeguard, report, supervision and punishment, bylaws, accessories including stem cell clinical trials research project application materials and stem cell clinical trials research project declaration.

        Four, the applied range of this file is what?

        "Stem cell clinical trials management method (trial)" is suitable for the stem cell research project declaration and registration of clinical trials, and clinical trial research and regulation, regulation of hematopoietic stem cell transplantation and except for the purpose of product registration of clinical trials.

        Look from the applicable objects, the stem cell clinical trials management approach (trial) provisions for stem cell clinical trials reporting unit, ethics committee, the committee of experts, as well as national and provincial health administration and the food and drug regulatory responsibilities.

        Five clinical trials, stem cell research management responsibility division of labor is what?

        To develop stem cell clinical trials research institutions must submit an application in advance. Declare unit is to be prepared in accordance with the regulations, stem cell clinical trials research project application form to fill out and submit the seat of provinces, autonomous regions and municipalities directly under the central government health department (bureau) and the food and drug administration (fda) to form authenticity review, review and submit it to the ministry of health and state food and drug administration clinical stem cell research and application of standard management work leading group office (hereinafter referred to as the "office"). Office organization expert group evaluation and field test in time, after, as stem cell clinical trials research project for the record list.

        For record after stem cell clinical trials should be in accordance with the drug clinical trial phase I, phase II and phase III order to carry out, and for the record after every 12 months to the office to submit a progress report submitted to the office after each test results report, approved by the office organization experts, can determine its into the next phase of clinical trials; To suspend and/or early termination of clinical research, and shall report to the office and the reasons why.

        Clinical trials in stem cell research in the process, if there is a serious adverse event, should stop immediately, stem cell therapy and its related clinical trials, and must be reported within 24 hours ethics committees and offices; If the violation of operating procedures and/or the measures of error events, and this event may be associated with the spread of the spread of disease or potential, or may cause pollution of the stem cell products, ethics committee and office also needs to report.

        Six, stem cell clinical trials research project how to carry out ethical review?

        Before submitting your application for clinical trials stem cell research, stem cell products must be the related materials, donor, and the selection criteria and the informed consent form sample subjects, clinical research the safety assessment of clinical trials and corresponding treatment measures, resume and research plan, the manual, the principal investigator to submit the corresponding ethics committee review, make ethical review opinions of the project, to protect the legitimate rights and interests of donor and subjects.

        Whether to allow charging seven clinical trials, stem cell research?

        "Stem cell clinical trials management method (trial)" clearly stipulated, phase I, phase II and phase III clinical trials in stem cells research all belong to in the experimental study on the stages of the human body, may not charge fees from the subjects.

        Eight, stem cell research is the main responsibility of the clinical trials?

        The stem cell clinical trials management approach (trial) "clearly stipulated that stem cell clinical trials must be conducted in stem cell clinical research base, stem cell clinical trials research project declaration unit and stem cells in clinical trials is stem cell research. The main responsibility of the clinical trials Application and research unit of the same institution, if the reporting unit must be connected to one or more of the stem cell clinical research base sign a contract, clear the responsibilities, rights and benefits of both or all parties.

        Nine, stem cell products how to control the quality?

        Used in clinical trials of stem cell products must be in accord with GMP standard site preparation and verification, etc. Stem cell clinical trials research project declaration shall be formulated under GMP conditions stem cell collection, separation, purification, amplification, calibration, packaging, preservation and transportation, standard operation and management of each link program and strictly according to standard procedure is carried out. Standard operating and management procedure should also include the training of operators and the use of materials, instruments, equipment and management, as well as the standard of clean environment, routine maintenance and inspection, etc.

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