Approach to maintaining comparability of biochemical data during long-term clinical trials

Statistical Analysis of Safety Data in Long-term Clinical Trials

In the past 40 years, approximately 150 drugs worldwide have been withdrawn from market for safety-related reasons since the withdrawal of thalidomide in 1961. A recent article claimed that serious adverse events (AEs) are now between the fourth and sixth leading cause of death in the United States. In the ICH-E9, it is clearly stated that in all clinical trials, the evaluation of safety and to...

Histomorphometrical changes of oviduct during the long-term exposure of breeder hens to extra thyroxine

In this research a 100 day long treatment period was considered to unmask the probable adverse effects of long-term induced hyperthyroidism on histomorphometrical attributes of the oviduct in broiler breeder hens. A total of seventy 47-week-old Cobb 500 breeder hens were randomly allotted to two treatment groups (5 replicates of 7 hens each). Thyroxine (T4) was orally administered to the hypert...

Evaluation of Toxicity in Long-term Clinical Trials.

Monitoring Data Discrepancies during Clinical Trials

Balancing the requirements of high quality data and timely completion of a clinical study is thankless task. On one hand the data must accurately reflect the trial conducted and on the other hand are the business needs that must be considered. Given enough time, all clinical trials would be able to have very high quality data with few if any errors. However, this is not a luxury that many will ...

Evaluation of Clinical Trials

In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...