Background: In noncommercial clinical drug research the implementation of the principles of Good Clinical Practice (GCP) has been criticized for introducing unnecessary bureaucracy at the expense of scientific activity, especially when small populations such as children or patients with orphan diseases are concerned.
Patients And Methods: From May 2003 to September 2005, we conducted two prospective open-label multicenter phase II studies in pediatric oncology. Aside from medical questions, these studies set out to explore the requirements according to the essential standards of the ICH-GCP Guideline in anticipation of the implementation of the EU Regulation in German Drug Law in August 2004; the latter, prospective investigation was initiated by the Coordinating Center for Clinical Trials (KKS).
Results: The main GCP requirements were systematically reviewed and critically discussed by focusing mainly on the situation of noncommercial pediatric drug research.
Conclusion: While putting GCP into practice in academic research increases costs, the challenge will be to apply these guidelines to good effect, for better quality and increased evidence.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1159/000098424 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Presurgical anxiety and acute postsurgical pain predict worse chronic pain profiles after total knee/hip arthroplasty.
Arch Orthop Trauma Surg
January 2025
Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Campus de Gualtar, Braga, 4710-057, Portugal.
Introduction: Total joint arthroplasties generally achieve good outcomes, but chronic pain and disability are a significant burden after these interventions. Acknowledging relevant risk factors can inform preventive strategies. This study aimed to identify chronic pain profiles 6 months after arthroplasty using the ICD-11 (International Classification of Diseases) classification and to find pre and postsurgical predictors of these profiles.
View Article and Find Full Text PDFPersonal interest and attitudes towards oocyte donation practice: a cross-sectional survey among Dutch-speaking young women in Belgium.
J Assist Reprod Genet
January 2025
Brussels IVF, Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Purpose: This survey aimed to assess the public's knowledge and opinions on oocyte donation (OD) among a large, unselected cohort of young Belgian women, and to explore aspects that could be enhanced to promote future OD programs.
Methods: We conducted a quantitative, epidemiological, cross-sectional web-based survey from February 2023 to April 2023. A private questionnaire was distributed to young women (21-30 years) living in Belgium via a digital link.
Giant encephalocele in newborns: prenatal diagnosis, management and outcome.
Childs Nerv Syst
January 2025
Department of Global Health, Faculty of Health Sciences, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada.
Background: A giant encephalocele associated with Chiari malformation is a rare congenital anomaly from a cephalad neural tube defect. Early prenatal diagnosis and parental counseling are essential; as early surgical intervention can improve outcomes.
Methods: Between 2010 and 2023, twenty-seven newborns out of 43,815 delivered at our institution were diagnosed with encephaloceles, including seven cases of giant encephalocele associated with Chiari malformation type III.
Postgraduate medical education in obstetrics and gynecology in Switzerland in comparison to Germany and Austria: the results of an international survey.
Arch Gynecol Obstet
January 2025
Frauenklinik Kantonsspital St. Gallen, St. Gallen, Switzerland.
Background: There is frequent academic exchange between Switzerland, Germany and Austria, facilitated by the common language. Additionally, the postgraduate training curricula in obstetrics and gynecology show some similarities. We aimed to compare self-perceived level of ability, availability of simulation training and teaching and feedback culture among residents in obstetrics and gynecology in Switzerland, Germany, and Austria.
View Article and Find Full Text PDFConsiderations for manufacturing of cell and gene medicines for clinical development.
Cytotherapy
December 2024
Cancer Institute, University College London, London, UK. Electronic address:
The global changes from 2001 that elevated substantially modified cell therapies to the definition of "medicinal product" have been the catalyst for the dramatic expansion of the field to its current and future commercial success. Europe was the first to incorporate human somatic cells into drug legislation with the medicines directive of 2001 (2001/83/EC), which led to the development of the term "advanced therapy medicinal products" (ATMPs) to cover all substantially modified products, tissue-engineered products and somatic cells that are not substantially modified but that are used non-homologously. For convenience, I use the term "ATMPs" throughout this review.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!