ArticlePloS one2016
Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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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.
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Who cites it
14 citing papers in PubMed.
- Feasibility of a randomized trial comparing exercise-based rehabilitation to no exercise-based rehabilitation after total knee arthroplasty: DRAW-TKA hybrid 1 RCT.Osteoarthritis and cartilage open · 2026Trial
- Adapting, restarting, and terminating a randomised control trial for people with cystic fibrosis: Reflections on the impact of the COVID-19 pandemic upon research in a clinical population.Contemporary clinical trials communications · 2024Article
- Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach With a Just-in-TIME Model.JCO clinical cancer informatics · 2023Article
- Examining Recruitment Strategies in the Enrollment Cascade of Youth Living With HIV: Descriptive Findings From a Nationwide Web-Based Adherence Protocol.JMIR formative research · 2023Article
- Clinical trial recruitment in primary care: exploratory factor analysis of a questionnaire to measure barriers and facilitators to primary care providers' involvement.BMC primary care · 2022Article
- Women with Cervical High-Risk Human Papillomavirus: Be Aware of Your Anus! The ANGY Cross-Sectional Clinical Study.Cancers · 2022Article
- Risk factors for spontaneous preterm birth among healthy nulliparous pregnant women in the Netherlands, a prospective cohort study.Health science reports · 2022Article
- Strategies for Successful Clinical Trial Recruitment of People Living with HIV in Low- and Middle-Income Countries: Lessons Learned and Implementation Implications from the Nigeria Renal Risk Reduction (R3) Trial.Current HIV/AIDS reports · 2021Review
- Recruitment of US Adolescents and Young Adults (AYA) into Human Immunodeficiency Virus (HIV)-Related Behavioral Research Studies: A Scoping Review.Current HIV/AIDS reports · 2020Article
- Primary care perspectives on implementation of clinical trial recruitment.Journal of clinical and translational science · 2020Article
- A multi-state model analysis of the time from ethical approval to publication of clinical research studies.PloS one · 2020Article
- Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal.International wound journal · 2019Article
- An Embodied Conversational Agent for Unguided Internet-Based Cognitive Behavior Therapy in Preventative Mental Health: Feasibility and Acceptability Pilot Trial.JMIR mental health · 2018Article
- Dealing with the positive publication bias: Why you should really publish your negative results.Biochemia medica · 2017Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPremature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear.
objectivesTo compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.
methodsWe systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.
resultsOf 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%).
conclusionsCompared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.
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