Scientific review - ensuring meaningful clinical research

This is the 5306th article of Da Yi Xiao Hu

1. What is scientific review?

Scientific review is a review of the necessity, scientificity and rationality of conducting clinical research. Its core purpose is to control the overall quality of the research, ensure the accuracy of the research data and the authenticity and reliability of the results, maintain the scientific rigor of the research, and fundamentally protect the legitimate rights and interests of research participants.

II. Objects and Contents of Scientific Review

(I) Subjects of Review

The objects of scientific review are mainly clinical studies initiated by researchers, also known as IIT studies. Sometimes, scientific review is also conducted on registered clinical studies for drug or medical device applications for marketing approval.

(II) Review Content

The scientific review thoroughly evaluates the necessity, rationality and feasibility of the research. The review content includes the research purpose, research hypothesis, research design, research methods, intervention measures, research endpoints, research safety, sample size estimation, etc., mainly including the following aspects:

1. Necessity of the study

Based on the understanding of the developments of similar research at home and abroad and the foundation of previous research, we should evaluate whether it is really necessary to conduct the research. At the same time, we should also consider whether the research has clinical significance, practical value and innovation.

2. Scientificity of the research

The research design should be scientific and rigorous, the criteria for selecting research subjects should be clear and reasonable, there should be a scientific and reasonable estimate of the sample size, accurate statistical methods should be selected for analysis, and the results and conclusions derived from the research should be reliable.

3. Study feasibility

The research should comply with ethical requirements, allocate resources efficiently and reasonably, ensure that there is a qualified team of personnel and sufficient scientific research funds to implement it, and that all objective conditions required for the research meet the requirements of the research plan and can be completed as expected.

4. Risk Control and Countermeasures

The research has a clear and scientific safety evaluation. It is capable of conducting a comprehensive assessment of possible risks and has effective risk prevention and control measures to fully protect the relevant rights and interests of research participants.

5. Qualifications of the research team

The research team members have the qualifications, capabilities and experience to carry out research work, have a complete organizational structure, clear and reasonable division of labor, and a clear training and assessment system.

3. Scientific Review Process

1. Application and Acceptance

Researchers should submit an application for scientific review of clinical research to the review agency, together with necessary documents such as the research plan, case report form, informed consent form, etc. The review agency should conduct a formal review of the application materials and formally accept the application after verifying that all necessary documents are complete and meet the requirements.

2. Connotative Review

Medical institutions that conduct clinical research generally have a scientific review committee composed of experts from multiple fields to conduct scientific reviews of accepted clinical research projects, including medical, statistical and research methodology experts. The review method is generally divided into letter review and meeting review, and the specific review method is determined based on the specific characteristics of the clinical research project, the potential risk level and other relevant considerations.

(III) Review feedback

The review agency will provide written feedback on the review opinions to the researchers. Review opinions usually include conclusions such as "agree", "agree with necessary amendments", "re-examine with necessary amendments", and "disagree". Researchers should modify or improve the research plan accordingly based on the review opinions. The review agency should record the review results in detail and properly archive them to facilitate subsequent follow-up supervision and information inquiries. After successfully passing the scientific review, the research must be submitted to the ethics committee for ethical review. Different from scientific review, ethical review focuses more on issues such as risk-benefit assessment of research participants, with an emphasis on protecting their vital rights and interests.

(IV) Tracking and supervision

During the specific implementation stage of the clinical research project, the review agency is responsible for continuously tracking and strictly supervising the research process to ensure that the research is strictly carried out in accordance with the reviewed and approved research plan. If serious problems such as data falsification or violations of ethical principles are found during the research process, the review agency has the right to immediately terminate or temporarily suspend the approved research project to maintain the legality and compliance of the research and the legitimate rights and interests of the research participants.

IV. The significance of scientific review

Scientific review of clinical research is the cornerstone of ensuring medical development and progress. Through comprehensive evaluation of research plans by experts in various fields, we ensure that the research is necessary, scientific, and feasible. This process not only enables clinical research to efficiently explore cutting-edge treatment strategies and medical technologies, but also puts the safety and health rights of the majority of research participants in the highest position.

Author: Research Department of the First Affiliated Hospital of Chongqing Medical University

Ceramics Li Junlong