Abstract
While junior clinical researchers at academic medical institutions across the US often desire to be actively engaged in randomized-clinical trials, they often lack adequate resources and research capacity to design and implement them. This insufficiency hinders their ability to generate a rigorous randomization scheme to minimize selection bias and yield comparable groups. Moreover, there are limited online user-friendly randomization tools. Thus, we developed a free robust randomization app (RRApp). RRApp incorporates 6 major randomization techniques: simple randomization, stratified randomization, block randomization, permuted block randomization, stratified block randomization, and stratified permuted block randomization. The design phase has been completed, including robust server scripts and a straightforward user-interface using the "shiny" package in R. Randomization schemes generated in RRApp can be input directly into the Research Electronic Data Capture (REDCap) system. RRApp has been evaluated by biostatisticians and junior clinical faculty at the Icahn School of Medicine at Mount Sinai. Constructive feedback regarding the quality and functionality of RRApp was also provided by attendees of the 2016 Association for Clinical and Translational Statisticians Annual Meeting. RRApp aims to educate early stage clinical trialists about the importance of randomization, while simultaneously assisting them, in a user-friendly fashion, to generate reproducible randomization schemes.
Highlights
Randomization, as a basic principle of experimental design, plays an essential role in clinical trials [1]
A total of 6 major modifications were suggested for improving the quality and functionality of robust randomization app (RRApp) in response to the constructive feedback we received from the biostatisticians and clinical investigators at Icahn School of Medicine at Mount Sinai (ISMMS), along with the comments made by Association for Clinical and Translational Statisticians (ACTStat) attendees, inclusive of biostatistics faculty members from academic medical centers nationwide
Two of the 5 completed modifications, which included collecting the email of users for quality improvement and outputting a randomization scheme that could be directly incorporated into Research Electronic Data Capture (REDCap), were mentioned earlier
Summary
Randomization, as a basic principle of experimental design, plays an essential role in clinical trials [1]. The goal of randomization is to, theoretically, eliminate selection bias in the design and implementation phases of a study to ensure that the observed difference in outcomes between 2 or more treatment groups is due to the treatment/intervention alone [2]. Randomization plays an integral role in reducing threats to internal validity of trial findings when evaluating the efficacy of a treatment or intervention. An insufficient background in the design of clinical trials hinders their ability to effectively generate a rigorous randomization scheme to minimize selection bias and yield comparable groups
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