Objective To introduce how to use Stata software to implement the randomization of clinical trials. Methods Some examples were taken to describe how to implement the randomization of each kind of clinical trials. Results Stata implemented its required functions, such as simple randomization, stratified randomization, block randomization and the randomization of group treatment. Conclusion Stata can easily implement the randomization of clinical trials.
Objective To compare the balance of simple randomization, stratified blocked randomization and minimization. Methods Monte Carlo technique was employed to simulate the treatment allocation of simple randomization, stratified blocked randomization and minimization respectively, then the balance of treatment allocation in each group and the balance for every prognostic factor were compared. Results The simulation demonstrated that minimization provides the best performance to ensure balance in the number of patients between groups and prognostic factors. Balance in prognostic factors achieved with stratified blocked randomization was similar to that achieved with simple randomization. Conclusion Minimization offers the best balance in the number of patients and prognostic factors between groups.
ObjectiveTo analyze the current status of the application of randomization methods in randomized controlled trials (RCTs) which have been published in New England Journal of Medicine (NEJM).MethodsRCTs published by NEJM in 2018 were searched and collected. The characteristics of clinical trial design elements and the application status of randomization methods were comprehensively analyzed to distinguish blind trial and non-blind trial, and characteristics of application of randomization methods and selection of allocation concealment mechanisms of non-blind trials were summarized.ResultsA total of 151 RCTs were published in NEJM in 2018, in which blinded trials and non-blinded trials accounted for 75 (49.67%) and 76 (50.33%), respectively. 34 (22.52%) RCTs did not report specific randomization methods, and the remaining 117 (77.48%) reported. Among the latter, stratified block randomization accounted for the main body (72.65%), followed by block randomization (11.11%), minimization method (9.40%), simple randomization method (4.27%) and the others. There was no significant difference in the proportion of reporting or using randomization methods between blind and non-blind trials (P>0.05). In 76 non-blind trials, 38 (50.00%) clearly reported the concealment method of random allocation, among which 37 used the central randomization (97.37%) and 1 used envelope method (2.63%).ConclusionsThe current RCTs published in NEJM still have problems in the selection of randomization methods to be optimized and the transparency of randomization reporting to be improved.
ObjectiveThrough researching the "Automated Production Quality Management Specification 5th Edition" (GAMP5) promulgated by the International Society for Pharmaceutical Engineering, combined with domestic and foreign guidelines and regulatory requirements, to explore the practical methods for the verification of the central randomization system of clinical trials.MethodsThe GAMP5 verification process and specifications of the clinical trial central randomization system was established according to the GAMP5 guideline and domestic and foreign computerized system verification guidelines and regulations in combination with the characteristics of the clinical trial central randomization system, and the existing clinical trials central randomization system was used as an example to show the verification results.ResultsThe verification framework and process of the central randomization system met the requirements of the relevant regulations of clinical trials that had been constructed. For the existing system, a verification team was established, a verification plan was developed, and a computerized system verification was conducted in accordance with the V model to form a set of standardized verification documents.ConclusionsThe verification process of the central randomization system proposed by this research follows the GAMP5 specification and has high operability and reference value.