Clinical studies/trials safety monitoring

Card/ac e/fecfs Asymptomatic, nonspecific T-wave inversions were observed in 1 study more often in subjects receiving trospium than in subjects receiving moxifloxacin or placebo following 5 days of treatment. This finding was not observed during routine safety monitoring in 2 other placebo-controlled clinical trials in 591 trospium-treated overactive bladder patients. The clinical significance of T-wave inversion in this study is unknown. 

Serum creatinine and BUN, the most common indicators of renal function used in both clinical and preclinical safety laboratory panels, are relatively insensitive markers of injury, particularly for the renal tubules. Urinary measurements of alanine aminopeptidase and A-acetyl-beta-D-glucosaminidase and kidney injury molecule-1 (KIM-1) can provide much more sensitivity when nephrotoxicity is a potential safety concern [28,29], These are also suitable for safety monitoring in early-phase human trials if preclinical studies validate such use to monitor product nephrotoxicity. 

Given the above preclinical observations, patients in a clinical study were monitored closely during treatment (including measurement of testosterone, luteinizing hormone, follicle-stimulating hormone levels, alkaline phosphatase, and serum vitamin A concentrations). This phase I clinical study of TAG-101 was conducted to determine the safety, toxicity, and pharmacokinetics of this agent in patients with advanced cancer. Currently, the drug is in a phase I/II clinical trial for advanced hepatocellular carcinoma. 

The first clinical trials of a new compound generally take place in healthy volunteers. These studies seek to establish the initial safety profile in humans and obtain pharmacokinetic information. Up until this point, the extrapolation of the adverse events identified from preclinical studies to humans remains theoretical. Even adverse effects associated with other members of the drug class remain to be demonstrated for the product under study. Emphasis is placed on the clinical investigator to closely monitor the subjects for the development of any adverse effects and to attempt to determine whether a causal relationship exists between the event and the study drug. 

Safety monitoring in clinical studies can be both data and labor intensive. In the context of later-stage therapeutic exploratory and therapeutic confirmatory trials, the collection of laboratory data is no exception. Typically, participants in clinical trials provide blood or urine samples at every clinic visit. There is an expansive range of clinical chemistry tests that can be conducted using these samples. 

Clinical trials are studies to evaluate the effectiveness, pharmacokinetics, and safety of medications or medical devices by monitoring their effects on large groups of people. Clinical research trials may be conducted by government health agencies, researchers affiliated with a hospital or university, independent researchers, or private industry. The use of an approved medicinal product in nonapproved conditions (different administration route, dose, clinical indications, etc.) requires also a new clinical trial. 

---