Rationale: An effective randomization system is crucial to the design, conduct, and analysis of any randomized controlled trial (RCT). Despite the apparent ease of flipping a coin (either literally or with a computer algorithm), designing a reliable randomization system that meets the design, statistical and logistical requirements for real-world use in an RCT is a major challenge. Multicenter critical care studies, for example, typically require extremely rapid access to a centralized system (24 hours/day), for randomization of time-sensitive interventions, while maintaining blinding and balanced recruitment between treatment arms and entry criteria strata. Large scale NIH and industry funded trials can invest in designing, building and hosting web-based randomization systems that accomplish these goals, but the costs of doing this are prohibitive for smaller trials with more constrained budgets. The design and implementation of a state-of-the-art randomization system that could be made available to the global research community at very low cost would facilitate the conduct of properly designed and blinded RCTs and remove an important barrier to the conduct of interventional research.
One commentor gave us 2 web sites that were already set up to do what we had proposed. Thanks for the referrals. We were not aware of them before and had not found them on our search.
These are indeed usable platforms for randomizing patients in clinical trials. I have tested them out and they provide just the system that we were proposing to create. The prices are not unreasonable either: one system is better for smaller studies (http://www.randomizer.at)(start up cost is $600 for first 50 enrollees and then $5/ additional enrollee; the other system (http://www.randomize.net/) has a flat fee of $2500 and is independent of the size of the enrollment (good for large studies).
It would be a good idea if the CTSI could post these web addresses on the CTSI web site resource page to alert investigators that there are inexpensive randomizer sites available for their studies.
We will withdraw our proposal.
Commenting is closed.