Sunday, August 2, 2009

     

 
 

 

GLOBAL CLINICAL TRIALS:  Using the Translator as a Recruitment Tool

 

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Translators are notoriously not provided with an understanding of the purpose of a project.  This is not intentional.  It is the product of many people seeing translation as a non-strategic entity, just a required piece of the global puzzle.  Changing this thinking can improve your patient recruitment and retention figures.

 

It’s a fact: patient recruitment can make or break a clinical drug trial.  Most pharmaceutical industry studies indicate as many as 80 to 90 percent of clinical trials fail to complete on time and at least 72 percent of trials go over by at least one month.  With the average daily cost of running an average phase III trial costing around $35,000 per day, time is indeed money.  The usual culprit in creating trials that run over is a lack of consistent enrollment at the trial site.

 

Keeping this in mind, many companies spend hundreds of thousands of dollars to hire a firm that will develop a recruitment strategy and identify potential populations for the study.  Rarely, however, does anyone stop to consider how the recruitment strategy needs to be adjusted in order to adapt to the cultural influences on participation.

 

In the United States, for example, sponsors run radio ads encouraging people with a specific ailment who satisfy certain criteria to call a number to inquire about participating in a clinical study.  Then trial sites are added in South Korea.  The documents and radio ads are translated and they look great  However, no one stopped to contemplate that Koreans consider radio ads to be an untrustworthy source for information on resources concerning their health and only trust a doctor from which to get this information.  Changing the language is not enough.  A translator specializing in clinical trials knows this.

 

Translators understand the sponsor needs to enroll quickly, get good consents, have ready access to their data and be able to retain the participants for the life of the study.

 

They also understand that culture drives willingness or lack of willingness to consent.  Not language.  A woman will not consent because she feels that participation is a decision she cannot make without her husband’s approval.  No straight translation will work to ease this cultural issue.  But subtle changes can be made, within the translation process that addresses these issues.  Adapting recruitment and retention material can be easily done – and can have a great impact cross-culturally.

 

Translation agencies need to be provided with a mandate that allows for excellence.  This excellence, appropriate for patient recruitment and retention, comes from less rigidity and more focus on content and purpose.  Translators need to be involved in the planning and implementation of the strategy for a trial.  They will, ultimately, be responsible for communicating across languages and, hopefully, across cultures.

 

A culturally applicable retention program is the key to successful and consistent patient enrollment.  Translators are an underutilized resource that can help mold recruitment tactics that work.

 

Sherry Dineen

Editor, aiaConnect