Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Bethel, MA; Sourij, H.
Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice.
Curr Cardiol Rep. 2012; 14(1): 59-69.
Doi: 10.1007/s11886-011-0229-7
Web of Science
PubMed
FullText
FullText_MUG
- Co-Autor*innen der Med Uni Graz
- Sourij Harald
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future. Here, we review the circumstances giving rise to the FDA guidance and describe the characteristics of clinical trials registered on ClinicalTrials.gov in the 36 months before and after the guidance was issued. We noted a doubling in the number of cardiovascular outcome trials registered and a sixfold increase in the median number of patients included in cardiovascular outcome trials in the latter 36 months. As the size and duration of follow-up for these trials increases, the clinical trials industry will need to adapt. The present review summarizes current attempts to streamline trial design and management to meet the requirements efficiently while adhering to the highest scientific standards.
- Find related publications in this database (using NLM MeSH Indexing)
- Cardiovascular Diseases - chemically induced
- Clinical Trials as Topic -
- Diabetes Mellitus - drug therapy
- Diabetic Angiopathies - chemically induced
- Female -
- Guideline Adherence -
- Health Policy -
- Humans -
- Hypoglycemic Agents - adverse effects
- Male -
- Practice Guidelines as Topic -
- Research Design -
- Research Design - epidemiology
- United States Food and Drug Administration -
- Find related publications in this database (Keywords)
- Type 2 diabetes
- Cardiovascular outcome
- Outcome trials
- FDA guidance
- Diabetes drugs