Trial reportThe pharmacogenomics journal2023
The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial.
Trial report in The pharmacogenomics journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02297126 (A Prospective Randomized Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program at Eskenazi Hospital), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Randomized Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program at Eskenazi Hospital
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmacogenomics-assisted treatment versus standard of care in schizophrenia: a systematic review and meta-analysis.BMC psychiatry · 2024Pooled it
- Implementation of a pharmacogenetic panel-based test for pharmacotherapy-based supportive care in an adult oncology clinic.Clinical and translational science · 2024Trial
- Pharmacogenomics of antibacterial and antiviral therapies: Clinical actionability, evidence gaps, and future directions.Pharmacological reviews · 2026Review
- Results of the ACCOuNT Trial: A Multi-Institutional Prospective Pharmacogenomics Implementation Trial for African American Inpatients.Clinical pharmacology and therapeutics · 2026Observational
- Current State of Pharmacogenomic Implementation Into Care for Persons With Cystic Fibrosis.Pediatric pulmonology · 2025Article
- The association between the number of HLA risk alleles and drug allergy and its implications for HLA screening - a case-control study.The pharmacogenomics journal · 2025Article
- Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned.Clinical pharmacology and therapeutics · 2024Article
- A national-wide survey on clinical implementation of PGx testing into precision therapeutics for Chinese children: a long way before standard clinical practice.BMC health services research · 2024Article
- Prevalence of actionable pharmacogenetic variants and high-risk drug prescriptions: A Swiss hospital-based cohort study.Clinical and translational science · 2024Article
- A Pharmacogenetic Panel-Based Prediction of the Clinical Outcomes in Elderly Patients with Coronary Artery Disease.Pharmaceutics · 2024Article
- Clinical Utility and Implementation of Pharmacogenomics for the Personalisation of Antipsychotic Treatments.Pharmaceutics · 2024Review
- Pharmacogenetic analyses in people with dementia in Northeast Germany.Alzheimer's & dementia (Amsterdam, Netherlands)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
Adverse drug events (ADEs) account for a significant mortality, morbidity, and cost burden. Pharmacogenetic testing has the potential to reduce ADEs and inefficacy. The objective of this INGENIOUS trial (NCT02297126) analysis was to determine whether conducting and reporting pharmacogenetic panel testing impacts ADE frequency. The trial was a pragmatic, randomized controlled clinical trial, adapted as a propensity matched analysis in individuals (N = 2612) receiving a new prescription for one or more of 26 pharmacogenetic-actionable drugs across a community safety-net and academic health system. The intervention was a pharmacogenetic testing panel for 26 drugs with dosage and selection recommendations returned to the health record. The primary outcome was occurrence of ADEs within 1 year, according to modified Common Terminology Criteria for Adverse Events (CTCAE). In the propensity-matched analysis, 16.1% of individuals experienced any ADE within 1-year. Serious ADEs (CTCAE level ≥ 3) occurred in 3.2% of individuals. When combining all 26 drugs, no significant difference was observed between the pharmacogenetic testing and control arms for any ADE (Odds ratio 0.96, 95% CI: 0.78-1.18), serious ADEs (OR: 0.91, 95% CI: 0.58-1.40), or mortality (OR: 0.60, 95% CI: 0.28-1.21). However, sub-group analyses revealed a reduction in serious ADEs and death in individuals who underwent pharmacogenotyping for aripiprazole and serotonin or serotonin-norepinephrine reuptake inhibitors (OR 0.34, 95% CI: 0.12-0.85). In conclusion, no change in overall ADEs was observed after pharmacogenetic testing. However, limitations incurred during INGENIOUS likely affected the results. Future studies may consider preemptive, rather than reactive, pharmacogenetic panel testing.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.