News and Articles

Simpler Language, More Access to Results Sought for Clinical-Trial Volunteers

(By Laura Landro, The Wall Street Jurnal Health Blog, april 2012)

Pressure is growing on researchers to do a better job of communicating the results of clinical trials to the volunteers who participated.
As WSJ’s Informed Patient reports, groups like the Michael J. Fox Foundation for Parkinson’s Research are stepping up programs to help match patients to clinical trials.
Meanwhile, new FDA regulations that went into effect last month require that trial results be included in the federal ClinicalTrials.gov website after studies are completed. A number of summaries are already posted on the site, but they tend to be technical and aimed primarily at experts.

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No Longer Lost in TRANSLATION

(by Denise Myshko, PharmaVOICE, sep 2010)

The ability to rapidly recruit suitable participants is eroding the boundaries around the globe, and the emerging markets of Eastern Europe, Asia and Latin America are increasingly being tapped as potential sites. But trials in emerging markets present challenges, language being one of them.

Mr. Chris Ellis, from SRA, says the biggest mistake companies make when translating documents is trying to cut corners to keep costs down. SRA works with companies that provide trained translators experienced with medical terms and are native to the country and language that needs translating. These companies are audited for their SOPs, training procedures, turnover, holiday cover and verification services.

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Back Translation for Clinical Trial Documentation – Informed Consent Forms

(by Global Health Trials, June 2011)

Back translation should also be considered if the trial is particularly risky, is complex or there is any reason for wanting to be very confident that the consent form or other documents are being accurately translated without loss of meaning. It is not always necessary but there are situations when it would be important. Each trial should be considered in terms of the risk and complexity of the study, what is being asked of the participants and why it might be important to ensure there are no differences in means between different versions of study documents.

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Language Translation:  A Critical Component Of Today’s Clinical Trial

(by Mark P. Wade, Life Science Leader, 2010 Guide To Outsourcing Partners)

Trial planners realize they need all of their trial documents to be in the native languages of the patient pool, and those documents need to be culturally correct, certified, and, for Quality of Life instruments, validated.

Language translation is a critical element of a global clinical trial, but it is typically not a core competency of a pharmaceutical company, a CRO, or the protocol authors. With multiple geographies, there are many variables to manage to ensure certified, on-time translations.

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