14 research outputs found
Results of a quality control on non-interventional studies
Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality
Children in clinical trials: survey on the current situation in paediatric university clinics in Germany
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
Remuneration for non-interventional studies – results of a survey in the pharmaceutical industry in Germany
In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: GebĂĽhrenordnung fĂĽr Ă„rzte) by taking into account the actual efforts at the study center
Remuneration for non-interventional studies – results of a survey in the pharmaceutical industry in Germany
In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: GebĂĽhrenordnung fĂĽr Ă„rzte) by taking into account the actual efforts at the study center
GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC
Background: The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections – which affect study sites, laboratories, sponsors and contract research organizations (CRO) alike – make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured
Quality assurance in non-interventional studies
Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres. Before start of statistical analysis a statistical analysis plan (SAP) should be created. The use of standardized tables and figures is highly recommended. The basis of the report writing should be the STROBE-statement “Strengthening the Reporting of Observational studies in Epidemiology Initiative” containing a checklist of 22 points to be covered in the report. The development of own standard operating procedures (SOP) describing the processes during planning, conduct and evaluation of a non-interventional study as well as the quality management and the regular training of all involved people is also highly recommended. All accompanying measures to improve or to keep the quality of the NIS should not violate the concept of non-intervention
Aspects of vulnerable patients and informed consent in clinical trials [Aspekte schutzbedürftiger Patienten sowie der Einwilligung nach Aufklärung in klinischen Prüfungen]
[english] 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. <br>[german] 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 Patienten in eine klinische Prüfung aufzunehmen, ohne zuvor die mit seiner Unterschrift versehene schriftliche Einverständnis eingeholt zu haben, ist als schwerwiegendes Fehlverhalten anzusehen. Die Entstehung ethischer Leitlinien begann bereits vor christlicher Zeitrechnung mit dem Hippokratischen Eid. In allen danach für die klinische Forschung entwickelten Leitlinien wird verdeutlicht, dass eine Hauptfunktion der Einwilligung nach Aufklärung die Sicherstellung der Willensfreiheit ist, um auch so das Wohl der Teilnehmer in klinischen Prüfungen sicherzustellen. Minderjährigen ist es nicht möglich ein diesbezüglich bindendes Einverständnis zu geben, dieses Problem wird durch eine Kombination von elterlicher Zustimmung sowie soweit möglich der Einwilligung des Minderjährigen adressiert. Analphabetismus ist betreffs der informierten Einwilligung ein kritischer Aspekt, der die ganze Welt betrifft. Er existiert in allen Gesellschaften, allen Bevölkerungsschichten und in jeder Altersgruppe. Um die Kommunikation mit diesen Patienten zu verbessern, können neue Strategien mittels Verwendung von Videotapes oder animierten Illustrationen und Trickfilmen gelehrt werden. Letztlich scheint die mit dem potentiellen Teilnehmer verbrachte Zeit der beste Weg zu sein, um die Verständigung zu verbessern.Schlussfolgerung: Die Erforschung lebensrettender und lebensverbessernder neuer Behandlungen erfordert eine Partnerschaft, die auf guter Kommunikation und Vertrauen zwischen Patienten und Forschern, Sponsoren, Ethikkommissionen, Behörden, Juristen und Politikern basiert, damit auch schutzbedürftige Patienten ohne Einschränkung von den Ergebnissen kontrollierter klinischer Prüfungen profitieren können