CTSI Annual Pilot Awards to Improve the Conduct of Research

An Open Proposal Opportunity

RandomizationCentral.org: an open-source, web based randomization portal to support RCTs for the global research community

Submitted by Ronald Clyman on February 17, 2012 - 1:04pm Last revised by Anonymous on May 2, 2014 - 12:08pm.
Type: 
Proposal
Topics: 
Clinical Research
Early Translational Research
Regulatory
Proposal Status: 
Final Proposal

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.

Comments

Daniel Lowenstein - February 21, 2012 - 10:55pm
I think this is a GREAT idea! Clearly provides for a need encountered in many clinical trials, and should be self-sustaining with the right support model (charging a modest fee to users). However, are you sure this is not already available? I happened to come across the following two sites which, at least superficially, may be providing a similar service: http://www.randomize.net/?gclid=CNHJjP3_sK4CFeYERQod1COsRw http://www.randomizer.at/

Stuart Gansky - February 22, 2012 - 12:22am
I think this would be a very useful resource. As Director of the UCSF Dental Data Coordinating Center with trials in Boston and Southern California, the DDCC and I have had to develop remote randomization for person- and cluster-randomized trials -- actually we have concealment of the randomization schedule until consent is obtained and eligibility criteria met. We have worked with Forte Research System (formerly PercipEnz) to modify the OnCore CTMS software to accommodate our randomization schedules. A colleague from graduate school (Scott Hamilton) started a Bay Area company DynaRand (http://www.dynarand.com/) in 1998 to provide web-based dynamic randomization (it was bought by UnitedBioSource Corp). (randomizer.org is fine for generating a one-time randomization schedule, but it does not conceal the list until the proper time to randomize a participant. randomize.net charges $CDN2500 per trial.) Existing companies/sites seem to target pharma and be more expensive than (some) UCSF investigators can afford. The DDCC staff could help with delineating specifications, programming, and/or testing. Features such as permuted blocks, stratification, and concealment would be essential to include.

Stuart Gansky - March 8, 2012 - 1:44pm
fyi, Forte Research Systems just (at the OnSemble Conference) announced that OnCore CTMS software ver12.0 will have real randomization capability and can use permuted blocks and stratification.

Jesse Shantz - February 23, 2012 - 10:13am
I see this as a great plug-in to REDCap (http://project-redcap.org/). Have you looked into the feasibility of making your portal compatible with REDCap? I think that you'd want to talk with Scott Robertson (Scott.Robertson@ucsf.edu). He could bring the idea up with the consortium and help to figure out if integration would be possible. It would increase your user base exponentially given the number of projects that are run using the REDCap platform.

Ida Sim - March 6, 2012 - 1:30pm
Randomization support is clearly needed. While there are commercial offerings out there, your support for randomization design and simulation is added value. Ideally, this type of support would be integrated with clinical trial management systems, but short of that, I agree with exploring being a plug-in to REDCap. This would also be a great addition to our proposed Digital Clinical Research Center (http://accelerate.ucsf.edu/forums/improveresearch/idea/7054).

Jennifer Creasman - March 9, 2012 - 3:47pm
Adding access to something like RandomizationCentral.org is very important to the research infrastructure at UCSF. Multi-center study designs with small sample sizes need randomization to be centralized. The ability to produce block and stratified randomization designs would be an important feature of this randomization system and may not be available in current randomization websites/programs. This is a great idea!

Commenting is closed.