Health Literacy in Clinical Research Practice and Impact: Proceedings of a Workshop (2020) / Chapter Skim
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5 Designing Clinical Trials with Health Literacy Best Practices
5 Designing Clinical Trials with Health Literacy Best Practices
Pages 69-80
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From page 69... ...
Davis then posed questions and facilitated a discussion with the audience. The panelists were Emma Andrews, senior director in U.S./Global Medical Affairs at Pfizer Biopharmaceutical Group; Monika Mitra, Nancy Lurie Marks Associate Professor of Disability Policy, Lurie Institute for Disability Policy at Brandeis University; Jovonni R
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From page 70... ...
in clinical trials. Specifically, Mitra asked, how can we use the principles of health literacy to inform our research designs so that we can include PWD more effectively?
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From page 71... ...
Mitra referenced a 2014 study by Feldman and colleagues that reviewed 300 randomized controlled clinical trials and looked specifically at the inclusion of people with intellectual disabilities. They found that, out of the 300 studies, only 6 (2 percent)
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From page 72... ...
Agreeing with Rios and colleagues' analysis, Mitra noted that in order to effectively include PWD in clinical trials, the research community needs to move beyond universal design and think of inclusive and accessible research design. This should include the principles of universal design but also accommodation and modification.
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From page 73... ...
With regard specifically to clinical trials, Spinner leads the Diversity in Clinical Trials Initiative, a multimedia campaign to raise awareness about the importance of minority representation in clinical trials. One of the goals of the campaign, Spinner said, is to dispel some of the myths that exist in racial and ethnic minority communities about clinical trials and to introduce positive messages about clinical trials.
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From page 74... ...
Rebecca J Williams, Acting Director, ClinicalTrials.gov, National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health Williams began by saying that in her role at ClinicalTrials.gov she is privileged to sit at the cross-section of the clinical trials enterprise.
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From page 75... ...
Now there is a trove of informed consent documents available online, said Williams, and this is an opportunity to evaluate those documents and identify best practices. Another practice that came out of the rulemaking process, said Williams, is that ClinicalTrials.gov now requires, along with the results information that is being posted, that the full protocol document and statistical analysis be reported to allow for the evaluation of the results.
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From page 76... ...
For example, she suggested, education, housing, and transportation can all have important impacts on whether people participate in clinical trials. Taking the specific example of transportation, she asked, How does the person get to the clinical trial site?
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From page 77... ...
Balancing Patient, Community, and Funding Needs for Trials Davis then asked how investigators can balance the needs of patients and communities with the requirements of the funders of clinical trials. Williams answered that, often, lack of resources is used as an excuse for not being inclusive or taking health literacy into account.
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From page 78... ...
Nicole Holland from the Tufts University School of Dental Medicine asked how researchers can address historical abuses by the research community toward minority communities. Spinner answered that this "dark history" is one of the things they are trying to address with the clinical trials initiative.
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From page 79... ...
. She said that this is a challenge because there are very few from the AI/AN population who are enrolled in clinical trials.
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From page 80... ...
A survey of published clinical trials. Journal of Intellectual Disability Research 58(9)
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