ABSTRACT
Objective To provide a suggestion for physicians participating clinical research of how to write a clinical trial protocol correctly and standardly in the course of clinical trial design.Methods By exploring clinical trial protocols,we analyzed their common problems in the methodological details and the reporting standards with respect to typical cases.Results The common problems in the clinical trial protocols are:lack of clear outline when selecting the research subject;incorrect selection of research type;lack of comprehensiveness and accuracy of PICO elements;inappropriate application of methodologies in randomization and blinding;absence of statistical analysis plan;incorrect calculation of sample size;non-standard format of the protocol etc.Conclusions Many clinicans do not have enough understanding of the key points in designing the clinical trial and writing the protocol.However,the quality of the clinical trial protocol determines success or failure of the whole study.Therefore,carefully handling the technical details of PICO elements,methodology and statistics application,and writing the protocol in accordance with the CONSORT (Consolidated Standards of Reporring Trials) 2010 and SPIRIT (Standard Protocol Items:Recommendations for Interventional Trials)2013 Statements,are the key points that each clinical researcher should pay attention to.
ABSTRACT
Objective Through investigating the clinicians’ scientific research level and weakness,we can carry out targeted clinical research training systematically,and then strengthen their utilization of clinical resources and data,and finally promote the transformation of scientific research resuits.Methods Filling and submitting the online questionnaires through WeChat,a popular chatting tool in China,physicians from 13 affiliated hospitals of a university in Shanghai have joined this research.Results 507 valid questionnaires have been received online:In terms of clinical research capacity,there seemed to be more barriers in the following issues:comprehension of the types and applications to design a clinical trial,formulation of the details including PICO elements(Patient-Intervention-Comparison-Outcome),methodological application including the category and principle of randomization,the category and principle of blind method and how to control the confounding elements and probable bias,and statistical problems in scientific research including discrimination of the different definition between FAS(Full Analysis Set) based on the principle of ITT(Intention-To-Treat) and PPS(Per-Protocol Set),how to write a standardized SAP(Statistical Analysis Plan) and how to calculate the sample size of a trial),and various management of clinical trials including data management,follow-up management,adverse event management and so on,and writing a protocol and a CRF (Case Report Form) in a standard and professional way.As for the needs for training,the top three topics were how to design a clinical research in a standardized style,how to practice the methodology and how to utilize the statistical skills into clinical trials.Conclusions Standardized design and writing of clinical trial protocols according to the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items:Recommendations for Interventional Trials),and the application of epidemiological and statistical methods are still short boards that most clinicians need to improve urgently,also are what they most concerned about at the same time.So it is necessary for physicians to receive systematic clinical research training to enhance their scientific research capacity.