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3 Scientific Issues: Clinically Meaningful Inclusion
Pages 19-28

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From page 19...
... Community involvement requires real partnerships, not just occasional meetings with community leaders. Involving minorities in clinical trials requires changes among many of the stakeholders in the clinical trials system, not just among researchers, government officials, or advocacy groups.
From page 20...
... In a heart failure study, a selfefficacy questionnaire asked potential patients how confident they were that they could take all their medicines as prescribed and follow a low-salt diet, and respondents with low self-efficacy were excluded. Horowitz asked the workshop participants who had been involved with clinical trials whether they would take part in their own studies.
From page 21...
... Social marketing, street art campaigns, and other forms of outreach sought participants. The study provided community benefits such as employment and capacity building, and team members did not need a primary care provider, literacy, or a Social Security card in order to enroll in the research.
From page 22...
... An inclusive approach was again the answer, said Horowitz, with formative research to develop outreach, a stakeholder board that included patients and community leaders, and stakeholder engagement throughout. For example, the board changed aspects of the study design and worked with the IRB at Mount Sinai to gain approval of study modifications.
From page 23...
... During the design phase, the inclusion of patient perspectives allows for designs that encourage participation and reduce burdens on patients and caregivers, which creates the potential to improve recruitment and retention. Patient-focused drug development tools, if accepted by patients and regulators, can improve efficiency and provide data that are meaningful to patients, including novel clinical endpoints, clinical outcome assessments (including patient-reported outcomes)
From page 24...
... Arbitrary limits, such as 65 years as an upper limit for age, may generally be inappropriate, and the exclusion of patients with common concomitant illnesses should be done only if this is expected to affect treatment effect or safety, she added. As pointed out in the previous chapter, standard categories of race and ethnicity are widely acknowledged to be inadequate for understanding meaningful genetic differences.
From page 25...
... In addition, PhRMA also has created a website to provide educational resources and information about clinical trials.2 Some of the scientific challenges mentioned could be addressed by innovative designs and methodologies in combination with advanced drug development tools. These collectively have the potential to accelerate drug development while obtaining evidence-based information about subgroups in an efficient manner.
From page 26...
... The stakeholder and patient partners also can participate in the monitoring of data and safety issues, and they can help to think about how to make the studies more efficient by capitalizing on existing resources, such as electronic health records, claims databases, or data networks. PCORI has initiated more than 200 studies based on this model, which has revealed certain barriers that can arise in the course of such research, said Hickam.
From page 27...
... PCORI also is funding initiatives that focus on learning about best practices for trial recruitment. Its comparative effectiveness research methods program is looking at novel approaches to engagement and to informed consent.
From page 28...
... [But] it requires the commitment of investigators and skills in how to manage interdisciplinary teams and approaches." INCREASING DIVERSITY AMONG RESEARCHERS One topic that arose during this discussion session and several other times during the workshop involved the diversity of the researchers and research leaders conducting clinical trials.


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