How representative are clinical trial cohorts of the general CF population? Implications for trial planning
Copyright © 2023. Published by Elsevier B.V..
Understanding the number of patients eligible to participate in research is important to design protocols and define research priorities. We reviewed the records of all patients with CF, age 12+, who receive care at our centre. We assessed their eligibility for trial participation based on common trial inclusion/exclusion criteria. 643 patients were included in the analysis, 31 were modulator ineligible(MI). Only 198(31 %) of the total cohort and 7(23 %) of the MI cohort were eligible for participation based on the hypothetical criteria. The most common reason for ineligibility was ppFEV1 ≥90 % followed by clinical instability, complex comorbidity and anticipated inability to adhere to the protocol. We suggest this would be a useful exercise for centres planning to either participate in, or refer subjects into, upcoming trials to undertake for their own cohort. We also make suggestions for protocol designs that optimise the number of patients who are eligible to participate.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society - 23(2024), 1 vom: 26. Jan., Seite 68-72 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dobra, Rebecca [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Completed 20.03.2024 Date Revised 20.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jcf.2023.03.005 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365315303 |
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| 520 | |a Copyright © 2023. Published by Elsevier B.V. | ||
| 520 | |a Understanding the number of patients eligible to participate in research is important to design protocols and define research priorities. We reviewed the records of all patients with CF, age 12+, who receive care at our centre. We assessed their eligibility for trial participation based on common trial inclusion/exclusion criteria. 643 patients were included in the analysis, 31 were modulator ineligible(MI). Only 198(31 %) of the total cohort and 7(23 %) of the MI cohort were eligible for participation based on the hypothetical criteria. The most common reason for ineligibility was ppFEV1 ≥90 % followed by clinical instability, complex comorbidity and anticipated inability to adhere to the protocol. We suggest this would be a useful exercise for centres planning to either participate in, or refer subjects into, upcoming trials to undertake for their own cohort. We also make suggestions for protocol designs that optimise the number of patients who are eligible to participate | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical trials eligibility | |
| 650 | 4 | |a Trial design | |
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| 700 | 1 | |a Jones, Andy |e verfasserin |4 aut | |
| 700 | 1 | |a Madge, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Simmonds, Nicholas J |e verfasserin |4 aut | |
| 700 | 1 | |a Davies, Jane C |e verfasserin |4 aut | |
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