Summary:
The target market for conducting global clinical trials has changed significantly, moving beyond pharmaceutical early adopters to the mainstream marketplace. This shift has placed a heightened focus on the language challenges and complexity of running a global clinical trial.
More and more companies are moving toward ascending regions, such as India and China, to launch global trials, and are naturally looking at the downstream benefits these locations offer – access to large, drug-naïve populations, lower trial operating costs, and the ability to rapidly recruit suitable participants. This focus on end-benefits, however, fails to consider the deep challenges of the launch process itself, and companies who are not yet globally-proficient are likely to underestimate the critical role translation plays in that effort.
Overview:
Successful global clinical trials require early consideration of the costs, complexities, and risks of communications. Best practices for clinical trials translation ensure your global trials are efficient, cost-effective, and successful in all markets.
Translation should be considered in the beginning, during the planning phase of the global clinical trial. It is important that all parties involved have a realistic expectation of the costs, complexities, and risks of the translation process. Companies that are not making these calculations face unnecessary delays and cost overruns. Third party outsourcing organizations that underestimate the cost and delivery schedule of clinical translations often have to revert to the sponsor company to renegotiate costs. This can significantly delay the execution of a trial and make the outsourcing organization appear ill-prepared.
This white paper highlights the language challenges found in a global clinical trial and offers a number of best practices for managing the translation effort. Failure to adequately plan for translation introduces several new risk factors that must be considered in today’s highly-competitive pharmaceutical market.
