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Barriers to access to clinical trial data: Obstruction of a RIAT reanalysis of the treatment for adolescents with depression study
- Source :
- International Journal of Risk & Safety in Medicine. 33:299-308
- Publication Year :
- 2022
- Publisher :
- IOS Press, 2022.
-
Abstract
- 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.
- Subjects :
- medicine.medical_specialty
Adolescent
Cognitive Behavioral Therapy
Depression
business.industry
Health Policy
Public Health, Environmental and Occupational Health
General Medicine
Scientific literature
Clinical trial
Patient safety
Treatment Outcome
Fluoxetine
medicine
Child and adolescent psychiatry
Humans
Medical prescription
Psychiatry
business
Adverse effect
Depression (differential diagnoses)
Randomized Controlled Trials as Topic
Custodians
Subjects
Details
- ISSN :
- 18786847 and 09246479
- Volume :
- 33
- Database :
- OpenAIRE
- Journal :
- International Journal of Risk & Safety in Medicine
- Accession number :
- edsair.doi.dedup.....03fd4f71ef7f66eda8b4bf91fb11eb33