Directory of randomisation software and services

This is a directory of randomisation software and services for clinical trials, including both simple do-it-yourself software and 24 hour telephone randomisation services. It is intended to help people planning and seeking funding for clinical trials.

If you know of other software or services which should be included, please email Martin Bland mb55@york.ac.uk and they will be added to the directory. If your service is listed here and you do not want it to be, please email Martin Bland and you will be removed. This is a copy of the Directory of randomisation software and services running at St. George's Hospital Medical School.

This directory is partial. Exclusion from it does not imply that the service is inferior in any way, just tell us who you are and we will include you. Inclusion in it does not imply that the service has been approved by us. We take responsibility only for getting the links right.

Randomisation programs:

• Clinstat is an old DOS program by Martin Bland, which is free. It is suitable for small scale trials. It does blocked and unblocked allocations and random sampling. Randomisation is found under main menu option 8. It prints simple lists of random allocations. For stratified randomisation, just print a blocked randomisation list separately for each stratum.
• Minim is a DOS program by Stephen Evans, Simon Day and Patrick Royston. It does allocation by minimisation very effectively and is free. The authors have generously allowed us to put it on this site for downloading. It runs interactively through your study, as this is how minimisation works.
• Randomization.com is a free on-line randomisation program. It randomises while you wait. It prints simple lists of random allocations.
• GraphPad QuickCalcs, a free online calculator for scientists, offers simple random allocation into equal-sized groups.
• EDGAR, Experimental Design Generator And Randomiser, is a free on-line randomisation program by James K. M. Brown (John Innes Centre). This is designed for agriculture, and does Latin squares and split plots as well as simple randomisation. It randomises while you wait. It prints lists of random allocations.
• Stata is a commercial statistical analysis program. There is an add-on called "ralloc", written by P. Ryan, that does blocked randomization, stratified randomization, or both. Stata is a great program for analysis, though you would not buy it just to randomise. In the UK, Stata is supplied by Timberlake Consultants.
• EaSt 2000 is a commercial program for sequential trials, aimed at the pharmaceutical industry.
• PARADIGM Registration-Randomisation Software is a web-based package produced by the Netherlands Cancer Institute and the UK Medical Research Council Cancer Trials Office. It is free and runs through your study interactively.
• KEYFINDER by Pete Zemroch is a menu-driven interactive program suitable for statisticians. It produces factorial designs, including blocked and/or fractional-replicate designs with user-specified confounding and aliasing properties. KEYFINDER is available free of charge. (This link also leads to other advanced statistical design programs.)
• Iain Buchan's programme StatsDirect carries out randomisation into two groups and in matched pairs, among many other statistical functions. The software is semi-commercial, in that the revenue is used for more research in computational statistics, but the cost is relatively low.

Randomisation services:

These provide trial support services including telephone randomisation. These are not free. You must discuss your trial with the centre and agree their involvement before applying for your grant. These services are not cheap. 10 pounds per patient randomised is typical. They also provide many other collaborative services for trials. Some of these organisations have their origins in academic research, others are purely commercial. Telephone randomisation may be provided during normal working hours or 24 hours per day. You should check what service you need and what the service provider offers. You should also check what out-of-hours procedure they provide. This might be a voice activated computer, a person sitting by the phone, or a phone directed to someone doing something else.

• Health Services Research Trial Support Unit, Dept of Health Sciences, University of York. This group works in collaboration with researchers on all aspects of trial design and analysis, including telephone randomisation.
• Birmingham Clinical Trials Unit offers customised minimisation randomisation programs as well as a telephone service.
• MRC/ICRF/BHF Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, carries out large-scale collaborative trials.
• The Northern and Yorkshire Clinical Trials and Research Unit (NYCTRU) at the University of Leeds offers a wide range of collaborative trial services.
• The Health Services Research Unit (HSRU) at the University of Aberdeen offers a 24-hour automated telephone randomisation service. Please direct all enquiries to Gladys McPherson gcm@hsru.abdn.ac.uk .
• Clinical Trials Research Unit (CTRU), Faculty of Medical and Health Sciences, University of Auckland, New Zealand offers 24 hour randomisation.
• The NHMRC Clinical Trials Centre of the University of Sydney, Australia, provides a randomisation service, available daily from 6 a.m. to 8 p.m. (24 hours a day for acute cardiovascular trials).
• Duke Clinical Research Institute (DCRI) Duke University Medical Center, USA, offers Randomization: a 24-hour on-site, staffed randomization service with interactive voice response system technology and emergency unblinding.
• Rho, Inc. Randomization Systems and Services offer an interactive voice response system for managing patient randomization during clinical trials, 24-hour.
• Nottingham Clinical Research Limited (NCRL) provides a broad range of services oriented to the Pharmaceutical and Biotechnology industries. As well as an interactive voice response system NCRL provide statistics, data management, monitoring and drug and materials storage & distribution. Main expertise is in large cardiovascular outcome trials, in excess of 5000 patients.
• Covance InterActive Trial Management Systems offers randomisation by an interactive voice response system, oriented towards the pharmaceutical industry.
• The Sealed Envelope is a web-based on-line random allocation system.
• ClinPhone provides a service oriented towards the pharmaceutical industry, offering data collection as well as randomisation by phone.
• Clinical Data Care offers many trials services including telephone randomisation.
• ASCOPHARM offer a variety of central randomisation systems for the pharmaceutical industry.
• QMwave has developed Cymware, a service offering customised randomisation by minimisation and stratification, reachable by Internet and IVRS. Contact : info@qmwave.com.

Thanks for the information to Doug Altman, Jan Brogger, Iain Buchan, Tim Cole, Jon Cooke, Christian Coppe, Simon Coulton, Diana Elbourne, Johnathan Goddard, Jacqui Hill, Steff Lewis, Richard Martinez, Gladys McPherson, John C. Nash, Mark Nixon, Pete Zemroch, and a couple of Google searches.

This page was produced for applicants to the NHS South Eastern Regional R&D Project Grant Scheme.

You can read more about setting up research projects in the Statistics Guide for Research Grant Applicants. It's all good, but you might want to go directly to the Chapter on clinical trials.

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Last updated: June 28, 2004