Barriers to access to clinical trial data : Obstruction of a RIAT reanalysis of the treatment for adolescents with depression study
BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. Data to verify efficacy outcomes are now more accessible; however, little has been done to ensure public access to harms data from RCTs, which are equally important in ascertaining possible misreporting and protecting safety.
OBJECTIVE: The treatment for adolescents with depression study (TADS) has influenced most international practice guidelines for treating children and adolescents with depression, supporting first-line prescription of fluoxetine in combination with cognitive behavioural therapy (CBT). However, after over 30 publications by the TADS team, reporting on harms remains highly deficient and we aimed to redress this lack.
METHODS: In undertaking a restoring invisible and abandoned trials (RIAT) reanalysis of TADS' effectiveness and safety outcomes, we sought access to de-identified serious adverse events (SAE) data.
RESULTS: This paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS' data custodians, highlighting several problematic blocks to comprehensive safety reporting.
CONCLUSION: Comprehensive access to clinical trial data is necessary to ensure safe and fully informed guidelines for treating children and adolescents with depression.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
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| Enthalten in: |
The International journal of risk & safety in medicine - 33(2022), 3 vom: 01., Seite 299-308 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Aboustate, Natalie [VerfasserIn] |
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| Links: |
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| Themen: |
01K63SUP8D |
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| Anmerkungen: |
Date Completed 23.08.2022 Date Revised 13.09.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.3233/JRS-210022 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM332576957 |
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| 100 | 1 | |a Aboustate, Natalie |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Barriers to access to clinical trial data |b Obstruction of a RIAT reanalysis of the treatment for adolescents with depression study |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 23.08.2022 | ||
| 500 | |a Date Revised 13.09.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. Data to verify efficacy outcomes are now more accessible; however, little has been done to ensure public access to harms data from RCTs, which are equally important in ascertaining possible misreporting and protecting safety | ||
| 520 | |a OBJECTIVE: The treatment for adolescents with depression study (TADS) has influenced most international practice guidelines for treating children and adolescents with depression, supporting first-line prescription of fluoxetine in combination with cognitive behavioural therapy (CBT). However, after over 30 publications by the TADS team, reporting on harms remains highly deficient and we aimed to redress this lack | ||
| 520 | |a METHODS: In undertaking a restoring invisible and abandoned trials (RIAT) reanalysis of TADS' effectiveness and safety outcomes, we sought access to de-identified serious adverse events (SAE) data | ||
| 520 | |a RESULTS: This paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS' data custodians, highlighting several problematic blocks to comprehensive safety reporting | ||
| 520 | |a CONCLUSION: Comprehensive access to clinical trial data is necessary to ensure safe and fully informed guidelines for treating children and adolescents with depression | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Patient safety | |
| 650 | 4 | |a antidepressants | |
| 650 | 4 | |a child psychiatry | |
| 650 | 4 | |a open data access | |
| 650 | 7 | |a Fluoxetine |2 NLM | |
| 650 | 7 | |a 01K63SUP8D |2 NLM | |
| 700 | 1 | |a Jureidini, Jon |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:33 |g year:2022 |g number:3 |g day:01 |g pages:299-308 |
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