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An increased number of companies are conducting clinical trials overseas.  According to a 2009 study conducted by two researchers at UNC and published in the New England Journal of Medicine, since 2002, the number of Food and Drug Administration investigators based outside the United States grew 15 percent per year, while those in the U.S. dropped by more than 5 percent.  Between 1995 and 2005, the number of clinical trials conducted overseas doubled.

Whether the driving factor is the economic downturn, lower costs or larger study populations, adding a multinational dimension to any clinical trial creates challenges.  Differing languages and cultures complicate communications, but for the informed consent portion of the trial, this can easily be overcome by electronic consenting.

Until recently, informed consent documents were typically presented to patients on paper, written on a fifth grade reading level and based on FDA and Review Board regulations.  To cover their liability risk, many companies included additional information resulting in an ever growing lengthy document (up to 20 pages long!)  This can take a long time for a patient to review.

The informed consent is integral to any clinical trial.  Ensuring it is handled uniformly in a study crossing geographically and linguistically diverse investigative sites is quite difficult.  A centralized consenting process through electronic consenting eases this difficulty.

Electronic consenting allows subjects to review the informed consent document (ICD) at their own speed, in a reading level that is comfortable for them and in their own language.  Terms requiring clarification can be hyperlinked to its definition and visual information can be provided in video clips.  For illiterate populations, sections of the ICD can be read out loud for them in their native tongue.

Electronic formatting can also allow trial administrators to gauge if a good consent has been obtained.  Especially in cases where a consent form is being created in a culture or language different from the study target population, how can you be sure your message is being understood?  Tracking the amount of time spent on sections or pages can indicate confusion or that a patient is skipping through the document.

It would appear that moving towards electronic formatting is a goal of the FDA as well.  To improve efficiency and move towards paperless clinical trials, the FDA announced in 2008 that electronic Common Technical Document (eCTD) is the preferred format for electronic submissions.  They have also established (along with Duke University) a “thinktank” called the Clinical Trials Transformation Initiative, whose goal is to modernize the clinical trial system.

No matter the reason for conducting clinical trials overseas, adopting electronic solutions for a truly informed consent in these cases has many advantages.  It allows for uniformly handled, centralized, good consents across languages and cultures.  It is also aligns with the current direction in which clinical studies are heading.

Electronic consenting creates competitive, agile solutions for efficiently reaching formerly untapped populations.  Moving quickly to take advantage of the efficiencies and opportunities it creates will keep companies competitive in the quickly expanding overseas marketplace.

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