Outsourcing to a well known CRO with a good reputation is vital to ensuring that data is well received by regulatory authorities, according to a CEO that just inked a deal for preclinical safety testing.
A significant number of articles in six of the top 10 medical journals in 2008 were ghostwritten, according to study by editors of JAMA that found responding authors reported a 10.9 per cent rate in the NEJM.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
US drug giant Pfizer has joined the growing list of organisations seeking to boost trial recruitment via the web, teaming up with IT firm Private Access to create a website designed to “increase clinical trial awareness and participation.”
Clinical trials in the developing world meet the same standards as those in Europe and the US and are vital for accelerating drug development says the Association of Clinical Research Organisations (ACRO).