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CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 10 ROUNDTABLE leaders Cookie-Cutter Informed Consent Creates Confusion, Not Comprehension to providing potential clinical trial participants with lengthy informed consent documents, filled with legalese, and expect them to truly understand what it means? Informed consent serves as the cornerstone of human-research subject protection. Yet proof of comprehen- sion of the documents that people just signed is not required and is rarely obtained. Next to the oil and tobacco companies, the pharmaceutical industry is one of the largest industries employing lawyers in the world. Pharmaceutical company legal departments charged with minimizing their company's exposure have traditionally provided clinical trial informed consent documents in a one- size-fits-all format. This may satisfy lawyers, but it doesn't really satisfy anyone else, and it does little to accommodate different patient learning styles, let alone facilitate their under- standing. Mitch Katz, Ph.D., executive director medical research operations, Purdue Pharma, says, "It doesn't inform the patient. It basically scares the living daylights out of them." Some advocate e-consenting as a solution. "The beauty of the e-consent is that the patient can go home, get on a website, and read it again," says Katz. "It gives you an opportunity to think about it more." However, e-consenting doesn't go far enough if it is only taking the lengthy document and putting it in an electronic for- mat. "The biggest excitement I have had in the past five years has been my ability to now make information visual for people so they can make better and faster decisions on study data," says Mark Anderson, executive director, global head of clinical data management at Alexion. "Information can be processed quickly on a regular basis, and there is the ability to generate graphs and other visual displays with some of the new software tools that really allow people to access specific patient data and explore interesting data trends." How to get that information translated back to the patient and caregiver so they can make bet- ter decisions going forward is the next step Anderson believes will result in real break- throughs. Recent research found that interactive informed consent produced statistically sig- nificant higher test scores than the standard paper consent. Using an iPad, the interactive informed consent provided subjects with mul- tiple options for hearing, viewing, and reading material. They can take a test and then get immediate feedback. Essentially, they have the ability to complete any form at their own pace. Subjects using the iPad spent nearly 10 more minutes viewing the informed consent than those using paper (22.7 minutes with the iPad vs. 13.2 minutes with paper). Even more telling is the fact that overall satisfaction and enjoyment slightly favored the interactive iPad presentation, despite taking nearly twice as long to complete. I recently had the opportunity to speak with an executive of a top-10 pharmaceutical com- pany testing an e-consent system similar to that described above. One of the initial find- ings was that it didn't have the ability to print out the informed consent forms. When I inquired if the patient was able to take the iPad home to view the e-consent at their leisure or open up the document online via a home computer, the answer was "No," illustrating why providing the patient with a printed ver- sion was so important. As research has dem- onstrated a greater level of engagement by patients using an interactive format, it is not clear why we want the patient to be engaged only when they are at the clinical trial site and not when at home. When you consider how the interactive approach accommodates mul- tiple learning styles and improves comprehen- sion, why then are we still sending the patient home with a printed version and expecting them to be able to adequately convey the consent information to friends and family in a single, noninteractive format? Greg Fiore, M.D., founder of SSI Strategy consultancy, says informed consent can't be just patient- centric, but must be people-centric. "If you want to improve clinical trials, let's start by improving the informed consent education process so as to increase comprehension and decrease confusion," Fiore says. L By R. Wright HOW TO IMPROVE CLINICAL TRIALS – SOME GOOD OLD-FASHIONED WISDOM odality teaching theory suggests that people have different learning styles — visual (sight), auditory (sound), or kinesthetic (touch/physical activ- ity), and that people learn best with educa- tional programs customized to meet their optimal style. In traditional education environ- ments, teaching has been implemented kin- esthetically from kindergarten through third grade, visually from grades four to eight, and through auditory means (i.e. lectures) from ninth grade through adulthood. This cookie- cutter approach has maintained widespread popularity despite numerous studies reporting its lack of effect. Though most learners use some combina- tion of the three styles, one or more is usually dominant and defines the best way for a per- son to learn new information. Why then do we as an industry take a cookie-cutter approach M Recent research found that interactive informed consent produced statistically significant higher test scores than the standard paper consent. 0 3 1 4 _ R o u n d t a b l e _ I m p r o v e . i n d d 5 0314_Roundtable_Improve.indd 5 2 / 1 9 / 2 0 1 4 1 : 4 1 : 4 1 P M 2/19/2014 1:41:41 PM

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