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Biggest challenges of multi-region clinical trials identified

A global health science marketing and communications firm, has released the results of its Global Trends Survey Report, to identify the biggest challenges of operating multi-region clinical trials and setting standards in emerging markets…

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A global health science marketing and communications firm, has released the results of its Global Trends Survey Report, to identify the biggest challenges of operating multi-region clinical trials and setting standards in emerging markets.

“In this report, we provide information on the reasons why clinical trials exit from the U.S. and Western Europe, the locations where clinical trials are especially difficult, and where they are most affordable,” said Anne-Marie Hess, senior strategic advisor at SCORR Marketing. “The report also shows predicted globalisation trends, the benefits to communities that host clinical trials and the priorities when setting global clinical trial standards.”

“The survey results indicated that investigator selection and training are the hardest areas in which to set standards in emerging markets,” said Lisa Henderson, editor in chief at Applied Clinical Trials. “Contract research organisations, however, said the clinical supply chain is the most problematic — indicating that there are no areas in which standard-setting is considered an easy task.”

Key results

The survey participants evaluated the difficulty of setting standards in emerging markets in four areas: clinical supply chain, investigator selection and training, language and site selection. On a 1–5 scale (with 1 being the most difficult), the average rating for establishing standards for investigator selection and training (2.33) was lower than for clinical supply chain (2.43), site selection (2.61) or language (2.64). The fact that the highest rating (2.64) is well below 3.00 – the statistical average of a 1-5 scale – indicates that there are no areas in which standard-setting is considered an easy task.

Gaining access to medicines is the biggest benefit

Gaining access to medicines is what benefits host communities the most, respondents said, even more than development of health care infrastructure, exposure to external expertise, and the boost to the local economy. On a 1–5 scale (with 5 being the highest), the average rating for access to medicines (4.57) was higher than for development of health care infrastructure (4.29), exposure to external expertise (4.16) or the boost to the local economy (3.84).

Countries/regions currently conducting clinical trials

North America and Western Europe remain the most popular places for clinical trials, although North America — along with the Middle East/North Africa — is the region where conducting clinical trials is considered to be especially difficult. India and Russia/Eastern Europe are thought of as especially affordable places to conduct clinical trials.

There is widespread belief that the trend toward globalisation of clinical trials will continue. None of the survey respondents believe this trend will be reversed, and just 5 percent believe that it will be stalled.

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