Randomization service

In every clinical study, the safety of the study participants has the highest priority. However, if the scientific validity and credibility of the results obtained are not ensured, the clinical trial would not be ethically justifiable. Careful study planning is the prerequisite for all statements on the quality of a clinical study and randomized therapy allocation is one of the most important quality features of a clinical study.

Randomization is the allocation of patients or subjects to a therapy group according to a procedure that has sufficient random elements to distribute prognostic factors to the therapy arms without foreseeable bias and thus create "structurally identical" groups that then differ only in that some patients receive the experimental therapy and other patients receive the control therapy.

Randomization is very important, but if the physician can predict which therapy the next patient would receive, randomization would not be sufficient as a quality criterion: even if the physician does not do this, it cannot be convincingly demonstrated that the randomization was not manipulated by swapping the order of patients at inclusion in the study. This would call into question the credibility of the study results. Particularly in open studies, central randomization is required to ensure that the patient is included in the study before the treatment allocation is announced.

The Institute of Biometry plans and offers various randomization procedures for clinical trials. These include telephone, web and fax randomization: telephone randomization is required if, for example, immediate therapy allocation is required in Emergency Medicine, even outside the hospital; web randomization is suitable if the randomization service must be available independently of business hours. Fax randomization is still very important when complex inclusion and exclusion criteria have to be checked before a patient can be included in the study.

The Randomization Service staff will be happy to advise you and help you select the appropriate randomization model for your specific clinical trial. Please register for a clinical trial consultation.