Duke CRO and Kaplan team on on-line trial training
The CREATe programme, initially available only through company sponsorship, is a suite of 28 online modules designed to train researchers in all aspects of the clinical trial process.
The core course uses US clinical trial regulations as a framework, however, the programme can be customised to take into account the differing cultural values that impact the increasing number of clinical trials conducted outside the country.
This flexibility is key according to DCRI director Robert Harrington, who said that the shortage of appropriately qualified clinical research staff around the world was the key driver for development of the new training programme.
He suggested that: “In some areas of the globe, such as India and China, the desire to participate in large clinical trials is strong, but there is a gap in training among the clinical research work force.
“To assure this global need is met, we now have a robust and comprehensive education and training program that can guarantee sponsors and participants alike an appropriately skilled workforce.”
Support for this idea came from a recent Duke study which showed that since 2002 the activity of US Food and Drug Administration (FDA) regulated investigators working outside the US has increase 15 per cent a year.
Additionally, recent data from the Planning Commission of India suggested that the country’s rapidly expanding trial sector needs an additional 30,000 to 50,000 personnel.
Site database
But, while the core focus will be on staff training, the course also offers potential benefits for both trial sponsors and contract research organisations (CRO) by creating a network of certified researchers, as DCRI explained.
“Students who complete the coursework will earn a certificate and site metrics will be maintained in a database that will be accessible to sponsors seeking appropriately educated personnel and research-ready locations.”
Kaplan COO Ryan Carpentier echoed the point and added that: “Sponsors will be able to conduct site recruitment by filtering the database of globally certified personnel by location, areas of practice, years of experience, and other criteria.”
“The clinical researchers, in effect, receive a portable DCRI-global certificate that provides them with recognition across multiple participating sponsors.”
