Suchergebnisse

Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google.Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual's freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor's assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. ; Ziel: Diskussion der Aspekte der Einwilligung schutzbedürftiger Patienten nach Aufklärung zur Teilnahme an klinischen Prüfungen aus europäischem und deutschem Blick.Methoden: Wissenschaftliche Literaturrecherche via PubMed, Medline und Google. Ergebnis: Das freiwillige Einverständnis ist ein Eckpfeiler aller Regularien von klinischen Prüfungen. Einen ...

Many prescribed treatments for children have not been adequately tested in children, sometimes resulting in harmful treatments being given and beneficial treatments being withheld. In the absence of specific trial-based data in children, results of studies in adults are extrapolated, which is often inappropriate because children have different range of diseases and metabolize medications differently. Trials in children are more challenging than those in adults and the pool of eligible children entering trials is often small. Children must have at last the same rights as adults in relation to receiving treatment with medicinal products that have been fully tested. The need for more studies to obtain paediatric information for medicines used in children is now a matter of consensus on a global basis and is considered a public health priority. Therfore a survey was performed in university hospitals in Germany targeting the current and future situation of children in clinical trials. The questionnaire of this survey was sent to 68 paediatric departments in 31 university clinics in Germany with a respond rate of 27% with respect to 18 returned questionnaires. With regard to new laws, guidelines and strong governmental support and funding an increasing number of clinical trials is expected. Surprisingly, the number of trials in the paediatric population remains unchanged within a period of 4 years (2005-2008). Added to the surveys performed within the pharmaceutical industry from Heinrich and Hark the number of trials in children remains unchanged even within a period of 9 years (2000-2008). The efforts undertaken by the government regarding funding and supporting KKS (Coordinating Centers for Clinical Trials) and affiliated PAED-Net (Pediatric Network on Medication Development and Testing in Children and Adolescents at KKS) appear to be insufficient. Beginning of this year the legal framework with the urgent expected "Paediatric Regulation" was established. May be the implementation by clinicians and pharmaceutical ...