Most experiments evaluating the effect of treatments on living organisms involve comparison between the responses of a group of individuals given the treatment and those of a group not treated (or given an alternative treatment). A frequent requirement in such studies is random assignment of individuals to treatment groups. The goal of this project is to develop an Interactive Registration and Randomization System (IRRS) providing comprehensive randomization functions to researchers, targeted particularly to clinical trials, but also usable for other types of randomized experiments. The proposed product will provide cost-effective, user-friendly access to all of the functionality necessary for professional quality, auditable registration and randomization. It will support all of the randomization procedures currently in use, accommodate double-masked, single-masked, and unmasked designs, and allow flexibility in study design. It will support simultaneous access by multiple users, simultaneous management of multiple studies, and support for multiple languages in the user interface. It will support access by touch-tone phone, or from any PC with Internet access and a standard web browser, or by dial-up modem over the switched phone network. All modules will be formally validated to ensure compliance with FDA requirements for software validation.
The aims of this grant are to finalize system requirements; design the architecture of the system; develop functional specifications; develop prototypes of the permuted block randomization algorithm; develop prototypes of the phone and web user interfaces; and use the prototypes to demonstrate the feasibility and merits of the system.
The software to be developed under this grant will permit pharmaceutical companies, NIH grant recipients, universities, and others conducting randomized experiments to quickly and inexpensively create professional- quality computer systems for patient registration and randomization, using both telephony and web-based user interfaces. The product will provide a cost-effective alternative to the """"""""home-grown,"""""""" single-use systems currently in use, offering significant savings for the thousands of randomized trials initiated each year (e.g., over 9,000 per year in human medical research alone).
