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Data monitoring committees (DMCs) are required in increasing numbers of clinical trials, but it is important to know when they are needed and to delineate their responsibilities carefully so as not to "create a monster," according to an expert speaking at a recent FDAnews audioconference.
While the FDA is working on at least five new guidances to promote adaptive clinical trials, experts cannot seem to agree on what precisely the term means.
Clinical investigators are key to the success of any clinical trial, yet many sponsors are not thinking through the best ways of recruiting and retaining them, according to a survey of 18 sponsors, seven clinical research organizations and 20 sites.
Clinical research networks (CRNs) should adopt a best practices approach to improve their performance in participant recruitment and retention, according to the conclusions of a newly released survey of 31 such networks.
Best practices guidelines regarding coverage of medical expenses for clinical trial research subjects who are injured as a direct result of their participation are hard to come by.
Sites and monitors may be unaware of differences in the regulations of clinical trials for devices as opposed to drugs, which can lead them to be concerned about the wrong things.
A statistical technique called Pure Likelihood could cut the cost and length of clinical trials by making it possible to use fewer participants and allowing more flexible data analysis.
Clinical trials are challenging to launch and operate but a sponsor's biggest problems can come at the end of a trial if the company doesn't have a strategic, proactive "exit strategy" to protect both participants and the company, expert Mark Barnes warned at a March 22 audioconference sponsored by FDAnews.
Know what you want your product label to say, get a handle on quality management early on, and have an overarching strategy before conducting clinical trials — even if it’s rough and you have to make changes.