Duke CRO and Kaplan team on on-line trial training

By Gareth Macdonald

- Last updated on GMT

Related tags Contract research organization Clinical trial Clinical research

US CRO the Duke Clinical Research Institute (DCRI) has teamed up with Kaplan EduNeering to develop a training programme to meet rising global demand for qualified clinical researchers.

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​.”

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1 comment

Globalisation is not new

Posted by John Lewis,

Duke Medicine should be commended for expanding training opportunities for international clinical investigators as more trained investigators are needed everywhere, including the United States. Unfortunately, this announcement ignores the fact that clinical research organizations, especially the global CROs who constitute the membership of the Association of Clinical Research Organizations, have been building a global research infrastructure for several years.

Currently, more than half of the 70,000 employees of ACRO member companies are outside the United States; or 35,000 well-trained clinical researchers in more than 115 countries, including thousands in India and China. Further, a preliminary study of multinational trials sponsored by ACRO, demonstrates that there are no quality differences across or among regions. We are happy to see that Duke is finally recognizing the importance of global research.

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