\nTherapeutic studies<\/strong> serve to test a new treatment concept or drug. Usually a newly developed drug is compared with the standard therapy or a sham drug (without effect, placebo). The sponsor<\/strong> of a clinical trial is either a pharmaceutical company, or the trial is planned by doctors, researchers or university research groups, then it is called an academic trial (Investor-Initiated Trial, IIT). inclusion\/exclusion criteria<\/strong> regulate who can take part in a study and at what stage, for example the age, sex and health status of a person. Before a study is approved, it must be approved by anethics committee<\/strong> The ethics committee examines the study with regard to its medical, scientific and ethical significance, compliance with legal requirements and the qualifications of the persons and organisations conducting the study. A proband insurance<\/strong> serves as a cover in case of health damages caused by the treatment in the study. The insurance pays for rehabilitation and, if necessary, required home reconstruction measures as well as financial losses, for example in the event of reduced earning capacity. <\/p>\n <\/p>\n
Studies are divided into different criteria<\/strong> , one or more of which may apply to a study:<\/p>\ncontrolled<\/strong> The results of the trial group that receives the drug under investigation are compared with the results of a control group that receives, for example, the standard therapy.<\/p>\nrandomized<\/strong>
\nParticipants are randomly assigned to one of the groups (arms).<\/p>\n(single) blind <\/strong>
\nThe participant does not know whether he or she is receiving the trial drug.<\/p>\ndouble-blind<\/strong>
\nNeither the doctor nor the participant knows whether the participant is receiving the study drug or the comparison drug.<\/p>\n <\/p>\n
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