2020
DOI: 10.1016/j.conctc.2020.100666
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The IGNITE trial: Participant recruitment lessons prior to SARS-CoV-2

Abstract: Full and diverse participant enrollment is critical to the success and generalizability of all large-scale Phase III trials. Recruitment of sufficient participants is among the most significant challenges for many studies. The novel SARS-CoV-2 coronavirus pandemic has further changed and challenged the landscape for clinical trial execution, including screening and randomization. The Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) study has been designed as the most comprehe… Show more

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Cited by 7 publications
(17 citation statements)
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“…This severely limits the generalizability of our findings and highlights structural racism and inequity related to clinical trial access. As a result, we have begun assessing the design of our trials and increased our efforts to inclusively design our exercise trials with and for underrepresented communities [ 72 75 ]. An additional limitation is the use of self-reported physical activity versus an activity monitor and lack of a treatment fidelity analysis.…”
Section: Discussionmentioning
confidence: 99%
“…This severely limits the generalizability of our findings and highlights structural racism and inequity related to clinical trial access. As a result, we have begun assessing the design of our trials and increased our efforts to inclusively design our exercise trials with and for underrepresented communities [ 72 75 ]. An additional limitation is the use of self-reported physical activity versus an activity monitor and lack of a treatment fidelity analysis.…”
Section: Discussionmentioning
confidence: 99%
“…20 As with rrAD, the most successful source may be dependent on inclusion/exclusion criteria and clinical trial requirements. 2,14,16 Currently, the field lacks high-quality evidence on the effectiveness of different approaches. 2,[14][15][16]19 Approximately 16% of individuals were excluded because they reported their BP did not meet the study criteria.…”
Section: Discussionmentioning
confidence: 99%
“…2,14,16 Currently, the field lacks high-quality evidence on the effectiveness of different approaches. 2,[14][15][16]19 Approximately 16% of individuals were excluded because they reported their BP did not meet the study criteria. Another 11% of individuals were too active, and 6.3% did not have a family history of dementia or subjective memory decline.…”
Section: Discussionmentioning
confidence: 99%
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