Clinical trials sponsor

Our first published report of the FDA data was accompanied by nine expert commentaries, some of them by researchers who had conducted clinical trials of antidepressant medication. Although there were vast differences in interpretation, this time there were no doubts about the accuracy of our analysis. Some commentators argued that our analysis had actually overestimated the real effect of antidepressants. Others argued that the clinical trials sponsored by the drug industry are flawed and that they may underestimate the actual benefit of antidepressants. But all... 

In the United Kingdom, the information sheet provided to the consenting study subject in a clinical trial sponsored by a pharmaceutical company will usually contain a reference to the clinical trial compensation guidelines of the Association of the British Pharmaceutical Industry (ABPI). It is not included in the information sheet of noncommercial studies. Study subjects taking part in clinical trials are not usually paid, unless it is... 

The new European Directive (2001/20/EC) has reinforced the need for European agencies, as well as those of the United States and Japan, to conduct inspections of clinical trials. Sponsors, mindful of the implications of failed inspections, are carrying out audits by their QA units to try to ensure that standards at a particular site meet the regulatory requirements of GCP, and of any future regulatory inspection. Frequently, the inspections will occur 2 or more years after the end of the study. 

Most recently, the collaborative work between the Nicolaou group at TSRI and our group at Novartis has resulted in the discovery of 20-desmethyl-20-methyl-sulfanyl-Epo B (32 = ABJ879) as a highly promising antitumor agent, ° which has recently entered phase I clinical trials sponsored by Novartis. 

All itraconazole clinical trials sponsored by Janssen Research Foundation for the treatment of onychomycosis, in which there was an assessment of laboratory safety, have been analysed (39). There were no significant differences in the number of code 4 abnormalities (baseline... 

In early 2009, a phase II clinical trial sponsored by a company aptly named CherryPharm was launched to determine the effects of drinking cherry juice on pain perception in subjects with severe knee osteoarthritis. This human research was based on laboratory studies charting inflammation-induced pain behavior in rats. Results showed that tart cherry extracts reduce inflammation-induced pain and edema similarly to a dose of the pain-relief drug indomethacin. Although these studies indicate that tart cherry anthocyanins may have a beneficial role in the treatment of inflammatory pain, most of this research is based on test-tube or rat studies, meaning that progress remains within the lower half of the research pyramid. 

Clinical trial sponsors also have the obligation to report safety information to investigators and ethics committees in a timely fashion. Ethics committees can be informed in an unblinded fashion within the same timeframe as the regulatory authorities, or in reasonable, regular intervals (commonly quarterly). The investigators can be updated periodically in a blinded fashion, provided that no compelling safety reason to unblind have emerged. 

For a subset of clinical trials, sponsors need to assess if there is a potential for the experimental drug to delay cardiac repolarization, an effect that can be... 

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