We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Although adaptive seamless design (ASD) in clinical trials offers many benefits, “there is no free lunch,” said Sue-Jane Wang, associate director at the FDA’s Office of Biostatistics. Read More
Regulations on human research protections are due for an update, following a quarter century of rapid technological change, said Ernest Prentice, the outgoing chair of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Read More
Clinical trial supply staffs are significantly larger in Phase III than in Phase II studies for both in-house and outsourced teams, according to a new study based on a survey of almost 40 pharmaceutical, biotech and medical device firms, as well as contract research organizations.
Devicemakers should be aware that clinical trial data is crucial to how the Centers for Medicare & Medicaid Services (CMS) will reimburse device manufacturers after approval, according to experts speaking last month at the annual Regulatory Affairs Professionals Society conference.
The key to success in postmarketing trials is motivating sites and investigators properly, Hugo Stephenson, president of Strategic Research and Safety at Quintiles, said in a recent FDAnews audioconference.
Outsourcing pharmacogenomics testing internationally can be of great benefit for trial sponsors seeking to develop targeted therapies to treat a variety of diseases, but there are a number of challenges, according to Andrea Pay, a senior clinical scientist at Quest Diagnostics Clinical Trials.
Some medical insurance carriers are allegedly telling prospective oncology clinical trial participants that if they do take part in trials, the insurance companies will no longer cover their routine costs of care for the investigational conditions.
Device firms that do clinical trials overseas can save time and money, increase efficiency and speed product approval timelines, but have to exercise more vigilance, experts say.
In the wake of recent high-profile clinical trial disasters such as the TeGenero clinical trial of its immune-boosting drug TGN1412, in which six volunteers were seriously injured and which led the company to file bankruptcy (CTA, July 27) (http://www.fdanews.com/cta/11_14/international/58180-1.html), the issue of whether trial sites and sponsors should provide insurance and compensation to injured research participants is gaining renewed attention.