Methodology quality assessment on study design and analysis of clinical research projects / 中华医学科研管理杂志

Objective Clinical research is a critical procedure for the development of medicine.Reliability of the clinical research finding is determined by the quality of study design and analysis courses.It will also further impact the guideline development and clinical practice.This study was focus on the evaluation of clinical research quality during its whole process.Methods Subjects of this study were the clinical summary reports from a government funded project which were submitted in 2016.Standardized data collecting form had been used to capture the key features regarding to the quality of study design and data analysis.After the review of data accuracy,descriptive analysis had been carried to interpret the observed findings both for design and analysis aspects.Results There were 67 project summary reports included in our analysis.The top three investigated therapeutic areas were oncology,cardiovascular/cerebrovascular diseases and orthopedics (19.4 ％,11.9 ％ and 11.9 ％).Most of studies fulfilled the evaluation criteria according to their original plan.94 ％ studies were strictly compliance with the original protocol with no interim amendment.Meanwhile,the report on sample size determination and appropriate use of multi-variable analysis should be improved.Conclusions Usually,clinical research program can fulfill the evaluate goal according to funding requirements.But the methodology quality should be paid more attention.It is highly suggested to cooperate with the professional statistical team and do continuous improvement effort to enhance the validity of study findings.

Bioanalytical Methodology Validation / 中国药房

OBJECTIVE: To introduce the methodology validation and quality control in bioanalytical procedures and its expected trend of development.METHODS: According to the bioanalytical validation reflected in FDA guidelines and other publications,based on the guidance of SFDA and the standard operating procedure of our phase I clinical trial lab,we summarized the procedure and questions of bioanalytical methodology validation.RESULTS: The methodology validation and quality control in bioanalytical procedures and the possible risks involved in the methodology validation were summarized.CONCLUSIONS: The established methodology validation in bioanalytical procedure and quality control contents were basically consummate,but the standards for the methodology validation should be formulated based on reality.