SynthesisTherapeutic innovation & regulatory science2023
Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
Synthesis in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 2 papers.
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 Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus
A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 1 Diabetes Mellitus
A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin With Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 Study
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study
A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study
A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study
A Comparison of LY2605541 Once Daily at a Fixed Time With LY2605541 Variable Time of Dosing in Participants With Type 1 Diabetes Mellitus: An Open Label, Randomized, Crossover Study
Who cites it
2 citing papers in PubMed.
- A University-Led Take-Back Program for Pharmaceutical Waste Management: Eleven Years of Real-World Evidence on Medication Non-Use and Disposal Patterns.Pharmacy (Basel, Switzerland) · 2026Article
- Important Considerations for Signal Detection and Evaluation.Therapeutic innovation & regulatory science · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundReasons for treatment discontinuation are important not only to understand the benefit and risk profile of experimental treatments, but also to help choose appropriate strategies to handle intercurrent events in defining estimands. The current case report form (CRF) commonly in use mixes the underlying reasons for treatment discontinuation and who makes the decision for treatment discontinuation, often resulting in an inaccurate collection of reasons for treatment discontinuation. METHODS AND
resultsWe systematically reviewed and analyzed treatment discontinuation data from nine phase 2 and phase 3 studies for insulin peglispro. A total of 857 participants with treatment discontinuation were included in the analysis. Our review suggested that, due to the vague multiple-choice options for treatment discontinuation present in the CRF, different reasons were sometimes recorded for the same underlying reason for treatment discontinuation. Based on our review and analysis, we suggest an intermediate solution and a more systematic way to improve the current CRF for treatment discontinuations.
conclusionThis research provides insight and directions on how to optimize the CRF for recording treatment discontinuation. Further work needs to be done to build the learning into Clinical Data Interchange Standards Consortium standards. CLINICAL TRIALS: Clinicaltrials.gov numbers: NCT01027871 (Phase 2 for type 2 diabetes), NCT01049412 (Phase 2 for type 1 diabetes), NCT01481779 (IMAGINE 1 Study), NCT01435616 (IMAGINE 2 Study), NCT01454284 (IMAGINE 3 Study), NCT01468987 (IMAGINE 4 Study), NCT01582451 (IMAGINE 5 Study), NCT01790438 (IMAGINE 6 Study), NCT01792284 (IMAGINE 7 Study).
Indexed as
Identifiers
36542287What OpenQuestion holds
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.