3 results
Search Results
2. Activation of Investigator-Initiated Clinical Trials with a Pharmaceutical for Cancer Patients before and after Post-Millennial Changes of Regulations in Germany and Europe.
- Author
-
Berdel, Wolfgang E.
- Subjects
- *
CLINICAL trial laws , *CLINICAL trials , *ACADEMIC medical centers , *INVESTIGATIONAL drugs , *CANCER patients , *MEDICAL protocols - Abstract
Simple Summary: This opinion paper describes the regulatory hurdles for a clinical oncologist and physician scientist to activate an Investigator-Initiated Trial (IIT) before and after 2004 with German regulation as an example. Changes in legal framework with impacts on time and costs to activate a clinical trial are described. Evidence needed to reach the objective of higher patient safety and trial quality by European Union (EU) Clinical Trial Directive (CTD) 2001/20 is discussed. Shortly after the beginning of the year 2000, multiple legal changes with impacts on the regulatory framework of clinical trials became effective almost simultaneously. They included the European Union (EU) Clinical Trial Directive (CTD) 2001/20 followed by major changes in national drug laws, the change in the legal status of German University Hospitals (1998), and a new disease-related groups (DRG)-based reimbursement system for hospitals in Germany (2000). Together, these changes created enormous bureaucratic and financial inhibition of activation and conduct of academic investigator-initiated clinical trials (IIT). Examples for activating clinical trials in oncology before and after 2004 are outlined and discussed, focussing on extended time frames, the establishment of centralized responsibility structures and the exploding financial consequences. In addition, the evolution of trial numbers and the distribution of trial initiators between "commercial" and "academic" over time are discussed together with the occurrence of clinical registries. At the same time, progress in molecular biology led to a plethora of new targets for effective pharmacological therapy of life-threatening diseases such as cancer, and the overall number of clinical trials has not decreased. Yet, judging the regulatory and administrative hurdles between scientific study design and first-patient on trial before and after 2004 and weighing these against the lack of evidence that this regulation has achieved its goal to enhance patient safety and trial quality, the necessity to completely overhaul this CTD becomes obvious. A main goal of such an initiative should be to minimize bureaucracy. For the specific situation in Germany, relocation of responsibility and freedom to operate in University Hospitals and Medical Faculties back to the physician–scientists and reduction in interference by legal divisions should be a goal as well as increasing the public financial support for IITs. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
3. Morphometric and Molecular Analyses of Ostertagia leptospicularis Assadov, 1953 from Ruminants: Species Diversity or Host Influence?
- Author
-
Wyrobisz-Papiewska, Anna, Kowal, Jerzy, Łopieńska-Biernat, Elżbieta, Nosal, Paweł, Polak, Iwona, Paukszto, Łukasz, and Rehbein, Steffen
- Subjects
- *
SPECIES diversity , *CATTLE , *ROE deer , *FALLOW deer , *RED deer , *BOVIDAE , *RUMINANTS - Abstract
Simple Summary: Pathogenic nematode Ostertagia leptospicularis, as the sole member of the subfamily Ostertagiinae, occurs in both cervid and bovid host species. The broad host specificity of this parasite draws special attention and requires a more in-depth investigation. This study was carried out to find out whether the differences in the nematode morphology were only due to the host influence, or whether genetic differences should be taken into account. To resolve this issue, the classification of O. leptospicularis was raised and discussed based on its host specificity, as well as morphological and genetic characteristics. A combined morphological–molecular approach was used to compare specimens resembling O. leptospicularis collected from naturally infected hosts of various ruminant species (roe deer, red deer, fallow deer, and cattle). Both morphological and molecular analyses highlighted the distinctiveness of O. leptospicularis collected from cattle in Germany, and therefore should now be considered to be a different strain that those collected form cervids in central Europe. Ostertagia leptospicularis Assadov, 1953 was formally described in roe deer Capreolus capreolus and has been reported in a wide range of ruminants, including other Cervidae, as well as Bovidae. Nematode specimens derived from various host species exhibit morphological similarity; however, some differences can be observed. It is unclear if this is due to the differential reaction of one nematode species in different host species (i.e., host-induced changes) or because of distinct nematode species in these hosts (i.e., species complex). This paper focuses on specimens resembling O. leptospicularis f. leptospicularis and its closely related species (Ostertagia ostertagi f. ostertagi) collected from various hosts. Morphometric and molecular techniques were applied to assess host-induced changes in nematode morphology and to clarify its systematic classification. There was an overall effect of host species on measurements of nematodes resembling O. leptospicularis (both males and females), but the distinctiveness of the specimens from cattle Bos taurus were highlighted. The results obtained may suggest that the specimens of O. leptospicularis from cattle in Germany and cervids in central Europe belong to different strains. Furthermore, nematodes from the cervid strain appear to circulate within particular host species, which can be seen in the stated morphological variations. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.