| pubmed-article:9173054 | pubmed:abstractText | Guidelines of good clinical practice regulate controlled clinical studies. Goal of the study, type of treatment and possible side effects have to be explained. The physician faces problems, if the study includes a "no treatment group". Referring to the literature and based on our own experience with tumor patients, several criteria are proposed to optimize the recruitment of patients. Important points are: Explanations should be given by an experienced doctor. He must be informed about the study and therapeutic alternative treatments. The atmosphere for the talk must be quiet. The participation of a person whom the patient trusts is desirable. The necessity of the study must be explained. Randomization in different study groups should be discussed without any preference. Prognosis should be explained without any detailed statistical data. Form of treatment, possible side effects and control examinations have to be discussed. The family physician's cooperation should be stressed. Personal autonomy in the patient's decision to participate in the study must be emphasized. Enough time for reflection must be granted before the final decision. It must be assured that the patient receives the same medical attention even after rejecting the study. These recommendations might help to avoid major mistakes which are harmful for the doctor-patient-relationship and further tumor therapy. A good initial discussion forms the basis for effective cooperation during tumor treatment. It may counteract the personal fear and negative reports in media of being "a guinea pig". The patient will appreciate the efforts of the doctor to provide optimal therapy. Furthermore, he will realize that such studies are necessary to improve future therapies. | lld:pubmed |
