Trial reportContemporary clinical trials2012
Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial.
Trial report in Contemporary clinical trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic review of interventional sickle cell trials registered in ClinicalTrials.gov.Clinical trials (London, England) · 2015Pooled it
- Analgesic management of uncomplicated acute sickle-cell pain crisis in pediatrics: a systematic review and meta-analysis.Jornal de pediatriaPooled it
- Experiences With a Multicomponent Digital Behavioral Pain Management Intervention for Adults With Sickle Cell Disease: Qualitative Analysis of the CaRISMA Trial.JMIR human factors · 2025Trial
- Challenges and Strategies: Nationwide Data Collection for an Internet-based Guided Relaxation Intervention in Sickle Cell Disease.Pain management nursing : official journal of the American Society of Pain Management Nurses · 2025Trial
- Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease.Clinical trials (London, England) · 2023Trial
- SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt.BMJ open · 2016Trial
- Simulation of various randomization strategies for a clinical trial in sickle cell disease.Hematology (Amsterdam, Netherlands) · 2016Trial
- Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: A Phase III international randomized clinical trial.American journal of hematology · 2015Trial
- A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children.Blood · 2015Trial
- Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea.Pediatric blood & cancer · 2013Trial
- IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies.Clinical trials (London, England) · 2013Trial
- Impact of PCA strategies on pain intensity and functional assessment measures in adults with sickle cell disease during hospitalized vaso-occlusive episodes.American journal of hematology · 2012Trial
- Near-Real-Time Clinical Trial Accrual Dashboard in a National Cancer Institute-Designated Cancer Center: Mixed Methods Implementation Study.JMIR medical informatics · 2026Article
- Hospital Variations in Time-To-Crisis-Resolution Among Children and Adolescents With Sickle Cell Disease.American journal of hematology · 2026Article
- TrialBench: Multi-Modal AI-Ready Datasets for Clinical Trial Prediction.Scientific data · 2025Article
- The Impact of Extended-Hours Patient Recruitment on Critical Care Clinical Trial Enrollment.Critical care explorations · 2025Article
- Insights from the trial innovation network's initial consultation process.Journal of clinical and translational science · 2025Article
- Protocol for applying an enhanced quality-by-design program across the translational science spectrum.Journal of clinical and translational science · 2025Article
- Design of an adaptive randomized clinical trial of intravenous citrulline for sickle cell pain crisis in the emergency department.Contemporary clinical trials communications · 2023Article
- A novel approach to conducting clinical trials in the community setting: utilizing patient-driven platforms and social media to drive web-based patient recruitment.BMC medical research methodology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundThe NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators.
methodsParticipating sites completed a missed eligibility log of subjects admitted in pain crisis throughout the study and a survey at the end of the trial. The survey covered site-specific factors, policies, and procedures in study implementation, recruitment strategies, and eligibility factors. The New England Research Institutes (NERI) collected de-identified surveys from 31 respondents at 29 of 31 participating sites.
resultsFrom December 2009 to June 2010, 1116 patient encounters for SCD and pain occurred at participating institutions: 38 subjects were enrolled (14 pediatric and 24 adults) and 34 completed the trial, below the projected 278 subjects. Fourteen sites enrolled subjects and seventeen did not. Recruitment barriers included insufficient staff, subject ineligibility or in too much pain to consent, competing protocols, and concerns regarding pain control. Recruitment methods were referrals from urgent care, SCD clinics and in house databases. No use of media or outside physicians was reported.
conclusionWe identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.
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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.