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Journal articles on the topic 'Trial outcomes'

Author: Grafiati

Published: 4 June 2021

Last updated: 25 July 2025

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1

Martinez, Robin. "Clinical Trial Outcomes." JACC: Heart Failure 7, no. 3 (2019): 272–73. http://dx.doi.org/10.1016/j.jchf.2018.12.003.

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Kelley, A. Taylor, Kara Mizokami-Stout, Matthew J. O'Brien, Michael E. Bowen, and Jeremy Sussman. "Hispanic representation in diabetes cardiovascular outcomes trials." BMJ Open Diabetes Research & Care 7, no. 1 (2019): e000656. http://dx.doi.org/10.1136/bmjdrc-2019-000656.

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ObjectiveTo examine Hispanic/Latino representation in diabetes cardiovascular outcomes trials for novel antidiabetic drugs.Research design and methodsWe compared Hispanic/Latino representation, age, gender and body mass index in diabetes cardiovascular outcomes trials published from January 2008 to October 2018 to Hispanic adults with diabetes in the National Health Examination and Nutrition Survey over the same time period.ResultsHispanics/Latinos comprised 18.5 % of trial subjects, which was similar to the proportion of US adults with diabetes who identify as Hispanic. Trial subjects were si

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Bousquet, Philippe Jean, Pascal Demoly, Giovanni Passalacqua, G. Walter Canonica, and Jean Bousquet. "Immunotherapy: clinical trials – optimal trial and clinical outcomes." Current Opinion in Allergy and Clinical Immunology 7, no. 6 (2007): 561–66. http://dx.doi.org/10.1097/aci.0b013e3282f1d6a4.

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Ellaway-Barnard, Christopher, Hannah Killick, Guy Peryer, Jane L. Cross, and Toby O. Smith. "The association between registration status and reported outcomes in physiotherapy randomised controlled trials." International Journal of Therapy and Rehabilitation 27, no. 3 (2020): 1–15. http://dx.doi.org/10.12968/ijtr.2019.0023.

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Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. T

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Perkins, David, Alan Owen, David Cromwell, et al. "The Illawarra Coordinated Care Trial: better outcomes with existing resources?" Australian Health Review 24, no. 2 (2001): 172. http://dx.doi.org/10.1071/ah010172.

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The Illawarra Coordinated Care Trial was one of nine Australian trials undertaken to see whether different modelsof coordinated care could improve the health of people with multiple service needs within existing resources. This papersummarises the findings of an extensive local evaluation and discusses the impact of the trial on clients and serviceproviders. It examines the main findings related to the principal trial hypothesis and points to lessons that mightinform the next round of trials.

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Bansal, R., R. Khan, N. Gimpaya, et al. "A160 PREVALENCE OF OUTCOME SWITCHING AMONG PUBLISHED PHASE 3 INTERVENTIONAL TRIALS FOR INFLAMMATORY BOWEL DISEASE THERAPEUTICS." Journal of the Canadian Association of Gastroenterology 4, Supplement_1 (2021): 167–68. http://dx.doi.org/10.1093/jcag/gwab002.158.

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Abstract Background Outcome switching is a well-described form of inconsistent reporting in randomized clinical trials (RCTs), wherein pre-specified primary and/or secondary outcomes are changed between trial registration and the publication of results without explanation. This is of particular concern, as the selective publication of results that are favorable will insert bias into the trial’s results and may cast doubt on the veracity of its findings. While it has been investigated in other disciplines, the prevalence of outcome switching has yet to be described among RCTs for inflammatory b

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Butcher, Nancy J., Andrea Monsour, Emma J. Mew, et al. "Guidelines for Reporting Outcomes in Trial Reports." JAMA 328, no. 22 (2022): 2252. http://dx.doi.org/10.1001/jama.2022.21022.

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ImportanceClinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis.ObjectiveTo develop harmonized, evidence- and consensus-based standards

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Thoma, Clemens. "IMvigor211 trial outcomes reported." Nature Reviews Urology 15, no. 3 (2018): 137. http://dx.doi.org/10.1038/nrurol.2017.225.

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Saad, Everardo D., and Marc E. Buyse. "Comparing the outcomes of noninferiority (NI) and superiority phase III trials." Journal of Clinical Oncology 30, no. 15_suppl (2012): e13055-e13055. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e13055.

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e13055 Background: We compared the outcomes of NI and superiority trials on advanced breast cancer (BC), non-small-cell lung cancer (NSCLC), and colorectal cancer (CRC). Methods: We searched PubMed for phase III trials on systemic antineoplastic treatments for advanced BC, NSCLC and CRC published between 1/1998 and 12/2009 in 11 leading journals. We categorized primary endpoints (PEP) as time-to-event (overall survival or any variant of progression-free survival), response rate, or other (quality of life or toxicity). We used the PEP (defined as the one stated explicitly, used for N calculatio

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Dames, Kevin D., Jeremy D. Smith, and Gary D. Heise. "Averaging Trials Versus Averaging Trial Peaks: Impact on Study Outcomes." Journal of Applied Biomechanics 33, no. 3 (2017): 233–36. http://dx.doi.org/10.1123/jab.2016-0164.

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Gait data are commonly presented as an average of many trials or as an average across participants. Discrete data points (eg, maxima or minima) are identified and used as dependent variables in subsequent statistical analyses. However, the approach used for obtaining average data from multiple trials is inconsistent and unclear in the biomechanics literature. This study compared the statistical outcomes of averaging peaks from multiple trials versus identifying a single peak from an average profile. A series of paired-samples t tests were used to determine whether there were differences in ave

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Leonard, Hampton, Cornelis Blauwendraat, Lynne Krohn, et al. "Genetic variability and potential effects on clinical trial outcomes: perspectives in Parkinson’s disease." Journal of Medical Genetics 57, no. 5 (2019): 331–38. http://dx.doi.org/10.1136/jmedgenet-2019-106283.

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BackgroundClassical randomisation of clinical trial patients creates a source of genetic variance that may be contributing to the high failure rate seen in neurodegenerative disease trials. Our objective was to quantify genetic difference between randomised trial arms and determine how imbalance can affect trial outcomes.Methods5851 patients with Parkinson’s disease of European ancestry data and two simulated virtual cohorts based on public data were used. Data were resampled at different sizes for 1000 iterations and randomly assigned to the two arms of a simulated trial. False-negative and f

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Marrie, Ruth Ann, Maria Pia Sormani, Sean Apap Mangion, et al. "Improving the efficiency of clinical trials in multiple sclerosis." Multiple Sclerosis Journal 29, no. 9 (2023): 1136–48. http://dx.doi.org/10.1177/13524585231189671.

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Background: Phase 3 clinical trials for disease-modifying therapies in relapsing-remitting multiple sclerosis (RRMS) have utilized a limited number of conventional designs with a high degree of success. However, these designs limit the types of questions that can be addressed, and the time and cost required. Moreover, trials involving people with progressive multiple sclerosis (MS) have been less successful. Objective: The objective of this paper is to discuss complex innovative trial designs, intermediate and composite outcomes and to improve the efficiency of trial design in MS and broaden q

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Razmovski-Naumovski, Valentina, Anthony Tanous, and Ross Valaire. "What Cachexia-Related Outcomes Are Measured in Lung Cancer Chemotherapy Clinical Trials?" Cancers 17, no. 14 (2025): 2309. https://doi.org/10.3390/cancers17142309.

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Background: Cachexia worsens prognosis, quality of life and chemotherapy treatment compliance of patients with lung cancer. Chemotherapy-induced cachexia has also been implicated in lowered mortality. This study aimed to evaluate the frequency of cachexia-related measures and symptoms as outcomes in lung cancer chemotherapy trial protocols and to examine how key trial characteristics influence them. Method: We conducted a cross-sectional data analysis of randomised controlled chemotherapy trials of lung cancer registered in four public trial registries between 2012 and 2023. Trial outcome meas

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Makutam, Viswakanth, Sai Yashashwini Achanti, and Marjan Doostan. "INTEGRATION OF ARTIFICIAL INTELLIGENCE IN ADAPTIVE TRIAL DESIGNS: ENHANCING EFFICIENCY AND PATIENT-CENTRIC OUTCOMES." International Journal of Advanced Research 12, no. 08 (2024): 205–15. http://dx.doi.org/10.21474/ijar01/19245.

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Background: Integrating artificial intelligence (AI) into adaptive trial designs represents a transformative approach in clinical research, promising enhanced efficiency and accuracy in trial outcomes. This study aims to systematically review the current landscape of AI applications in adaptive clinical trial designs. Methods: A comprehensive search was conducted across multiple databases, resulting in 6177 records initially identified. After removing duplicates and ineligible records, 1476 studies were screened. Following rigorous screening and eligibility assessment, 45 studies were included

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Snooks, Helen, Matthew Jones, Ashra Khanom, Ronan Lyons, and Alan Watkins. "PP28 Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care." Emergency Medicine Journal 37, no. 10 (2020): e13.1-e13. http://dx.doi.org/10.1136/emermed-2020-999abs.28.

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BackgroundThe use of anonymised routine linked data in designing and conducting randomised controlled trials (RCTs) has great potential. Sample sizes can be large, inclusion rates high and follow up periods prolonged, while the disruption to participants’ usual routines may be minimised. However, challenges and limitations in using routine linked data in RCTs remain. We sought to describe challenges and opportunities associated with designing and conducting RCTs using anonymised linked routine data in primary and emergency settings.MethodsSynthesis of trial designs used, regulatory processes f

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Khawaja, Zeeshan. "TRANSFORMING KIDNEY DISEASE OUTCOMES; THE REVOLUTIONARY IMPACT OF SGLT2 INHIBITORS." Pakistan Postgraduate Medical Journal 34, no. 03 (2023): 166–68. http://dx.doi.org/10.51642/ppmj.v34i03.604.

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The utilization of sodium-glucose cotransporter-2 (SGLT2) inhibitors for kidney ailments has been a story of unexpected developments. The initial study by Rossetti and colleagues in 1987 proposed the idea of blocking SGLTs in the renal tubules to stimulate glucosuria. The development of orally absorbed SGLT2 inhibitors in the 1990s resulted in numerous trials, including cardiovascular outcomes trials (CVOTs) that demonstrated the benefits of SGLT2 inhibitors in protecting against secondary kidney disease endpoints. Trials with kidney disease endpoints as primary outcomes further verified these

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Zhang, Wei, Nicholas J. DeVito, An-Wen Chan, et al. "Enhancing global clinical trial transparency for better health outcomes for all." F1000Research 14 (June 26, 2025): 626. https://doi.org/10.12688/f1000research.166358.1.

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Background In 2022, WHO’s World Health Assembly adopted resolution WHA75.8, emphasizing the critical role of clinical trials in generating high-quality evidence and promoting equitable access to health interventions globally. In response, rapid landscape reviews were conducted to assess global clinical trial regulations, capacities, and funding distribution. Methods The analysis synthesized regulatory frameworks from 94 countries, institutional capacity data from the WHO International Clinical Trial Registry Platform (ICTRP), and funding data from World RePORT for trials registered between 201

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S Kanavi, Raviteja, Akash Chathamvelli, and Deepjyoti Saikia. "Dostarlimab for Endometrial Cancer: A Comprehensive Review of Clinical Outcomes." International Journal of Science and Healthcare Research 8, no. 1 (2023): 136–44. http://dx.doi.org/10.52403/ijshr.20230119.

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Jemperli (dostarlimab) is an anti-PD-1 mab used to treat endometrial cancer. It is a humanized mab produced using rdna technology in CHO cells. It is approved in the US and EU and was developed by Tesaro, later acquired by GlaxoSmithKline. Clinical trial data on dostarlimab was reviewed using online sources such as PubMed, Cochrane, and Medscape. The review included English language clinical trials, randomized trials, original articles, newsletters, and letters to the editor. Results from the GARNET clinical trial an open-label, multicohort study, which showed reduced progression and recurrenc

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Retzer, Ameeta, Elin Baddeley, Stephanie Sivell, et al. "Core outcomes in Brain Tumour Trials – The COBra Study Review of Glioma Trial Registration Data." Neuro-Oncology 24, Supplement_4 (2022): iv5. http://dx.doi.org/10.1093/neuonc/noac200.019.

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Abstract AIMS Trial registration supports unbiased reporting of research studies. Despite inconsistent use globally and sub-optimal completeness, registration is associated with publication of the same outcomes as defined in trial protocols, though these are not necessarily reported in published results. In the core outcomes in brain tumour trials (COBra) study a registry review was undertaken, alongside a systematic review of qualitative literature and semi-structured interviews, to develop a core outcome set (COS) outcome longlist. The study aims to identify all outcomes reported across all

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Troost, Jonathan P. "Trial Outcomes in Glomerular Diseases." Clinical Journal of the American Society of Nephrology 17, no. 1 (2021): 11–13. http://dx.doi.org/10.2215/cjn.15001121.

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Perloff, Jeffrey M., Daniel L. Rubinfeld, and Paul Ruud. "Antitrust Settlements and Trial Outcomes." Review of Economics and Statistics 78, no. 3 (1996): 401. http://dx.doi.org/10.2307/2109787.

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Pearson, Adam M., Jon D. Lurie, Emily A. Blood, et al. "Spine Patient Outcomes Research Trial." Spine 33, no. 25 (2008): 2759–66. http://dx.doi.org/10.1097/brs.0b013e31818e2d8b.

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Zarzaur, Ben L., Rosemary Kozar, John G. Myers, et al. "The splenic injury outcomes trial." Journal of Trauma and Acute Care Surgery 79, no. 3 (2015): 335–42. http://dx.doi.org/10.1097/ta.0000000000000782.

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Alexander, L., and R. Hall. "Outcomes from the CARDia Trial." MD Conference Express 12, no. 13 (2012): 29. http://dx.doi.org/10.1177/155989771213021.

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Drysdale, Henry, Philip Hartley, and Ben Goldacre. "Outcomes in the EXAMINATION trial." Lancet 387, no. 10032 (2016): 1997–98. http://dx.doi.org/10.1016/s0140-6736(16)30464-0.

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Newman, David H., and David L. Schriger. "Trial Registration and Wandering Outcomes." Annals of Emergency Medicine 58, no. 1 (2011): 103–4. http://dx.doi.org/10.1016/j.annemergmed.2011.05.019.

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Newman, David H., and David L. Schriger. "Trial Registration and Wandering Outcomes." Annals of Emergency Medicine 59, no. 1 (2012): 76–80. http://dx.doi.org/10.1016/j.annemergmed.2011.07.025.

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Desai, Atman, Kimon Bekelis, Perry A. Ball, et al. "Spine Patient Outcomes Research Trial." Neurosurgery 71, no. 4 (2012): 833–43. http://dx.doi.org/10.1227/neu.0b013e31826772cb.

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Singh, Manish, Roland Rocafort, Cathy Cai, Kien Wei Siah, and Andrew W. Lo. "The reaction of sponsor stock prices to clinical trial outcomes: An event study analysis." PLOS ONE 17, no. 9 (2022): e0272851. http://dx.doi.org/10.1371/journal.pone.0272851.

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We perform an event study analysis that quantifies the market reaction to clinical trial result announcements for 13,807 trials from 2000 to 2020, one of the largest event studies of clinical trials to date. We first determine the specific dates in the clinical trial process on which the greatest impact on the stock prices of their sponsor companies occur. We then analyze the relationship between the abnormal returns observed on these dates due to the clinical trial outcome and the properties of the trial, such as its phase, target accrual, design category, and disease and sponsor company type

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Mbekwe Yepnang, Ariane M., Agnès Caille, Sandra M. Eldridge, and Bruno Giraudeau. "Association of intracluster correlation measures with outcome prevalence for binary outcomes in cluster randomised trials." Statistical Methods in Medical Research 30, no. 8 (2021): 1988–2003. http://dx.doi.org/10.1177/09622802211026004.

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In cluster randomised trials, a measure of intracluster correlation such as the intraclass correlation coefficient (ICC) should be reported for each primary outcome. Providing intracluster correlation estimates may help in calculating sample size of future cluster randomised trials and also in interpreting the results of the trial from which they are derived. For a binary outcome, the ICC is known to be associated with its prevalence, which raises at least two issues. First, it questions the use of ICC estimates obtained on a binary outcome in a trial for sample size calculations in a subseque

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Samuel, Joyce P., Susan H. Wootton, Travis Holder, and Donald Molony. "A scoping review of randomized trials assessing the impact of n-of-1 trials on clinical outcomes." PLOS ONE 17, no. 6 (2022): e0269387. http://dx.doi.org/10.1371/journal.pone.0269387.

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Background The single patient (n-of-1) trial can be used to resolve therapeutic uncertainty for the individual patient. Treatment alternatives are systematically tested against each other, generating patient-specific data used to inform an individualized treatment plan. We hypothesize that clinical decisions informed by n-of-1 trials improve patient outcomes compared to usual care. Our objective was to provide an overview of the clinical trial evidence on the effect of n-of-1 trials on clinical outcomes. Methods A systematic search of medical databases, trial registries, and gray literature wa

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Jones, Christopher W., Amanda Adams, Mark A. Weaver, et al. "Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial." BMJ Open 9, no. 5 (2019): e028694. http://dx.doi.org/10.1136/bmjopen-2018-028694.

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IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However,

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Kanapuru, Bindu, Harpreet Singh, Janice Kim, and Paul Gustav Kluetz. "Patient-reported outcomes (PRO) in cancer trials submitted to the FDA from 2012-2015." Journal of Clinical Oncology 35, no. 15_suppl (2017): e14024-e14024. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e14024.

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e14024 Background: PRO measures are commonly assessed in cancer trials. We reviewed the PRO strategy, tools and trial designs for new drug applications (NDA) and biologics license applications (BLA) submitted to FDA over a 4 year period. Methods: A review of protocols and clinical study reports for original NDA and BLA applications submitted to the Office of Hematology and Oncology Products between 2012 and 2015 to support initial approval for adult malignant hematology and oncology conditions was done. We reviewed applications for inclusion of PRO data, trial design, type of PRO measure emplo

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Ahmed, Mahbubl, Chee Goh, Edward Saunders, et al. "Germline genetic variation in prostate susceptibility does not predict outcomes in the chemoprevention trials PCPT and SELECT." Prostate Cancer and Prostatic Diseases 23, no. 2 (2019): 333–42. http://dx.doi.org/10.1038/s41391-019-0181-y.

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Abstract Background The development of prostate cancer can be influenced by genetic and environmental factors. Numerous germline SNPs influence prostate cancer susceptibility. The functional pathways in which these SNPs increase prostate cancer susceptibility are unknown. Finasteride is currently not being used routinely as a chemoprevention agent but the long term outcomes of the PCPT trial are awaited. The outcomes of the SELECT trial have not recommended the use of chemoprevention in preventing prostate cancer. This study investigated whether germline risk SNPs could be used to predict outc

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Langlais, Blake T., Gina Mazza, Crystal S. Langlais, et al. "Utilization of Patient-Reported Outcomes in Myeloproliferative Neoplasm Clinical Trials Registered at Clinicaltrials.Gov." Blood 132, Supplement 1 (2018): 5469. http://dx.doi.org/10.1182/blood-2018-99-117446.

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Abstract Introduction Patients with myeloproliferative neoplasms (MPN) typically experience debilitating symptom profiles and profound quality of life (QoL) decrements. Characterizing symptom burden in MPN clinical trials is vital to inform efficacy analyses. Previous studies have shown clinicians and researchers depend on patient-reported outcomes (PROs) to glean disease-related symptoms and signs of QoL decline. The current literature also shows that integrating PROs into the routine care of patients with cancer is associated with increased survival compared with usual care. However, the ext

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Masnur, Masnur, and Nadar Nadar. "Pengembangan SSP HOTS untuk meningkatkan Karakter dan hasil belajar peserta didik Kelas V SD." Edumaspul: Jurnal Pendidikan 4, no. 2 (2020): 115–21. http://dx.doi.org/10.33487/edumaspul.v4i2.716.

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This research aims to produce learning devices in the form of Subject Specifik Pedagogy (SSP) based on Higher Order Thinking Skills (HOTS) to improve the character and learning outcomes of students in Grade V Elementary School. This research is research and development, consisting of nine stages, namely: (1) research and data collection, (2) planning, (3) product draft development, (4) initial field trials, (5) revising field trial results, (6) field trials, (7) improvement of field trial products, (8) field execution trials and (9) final product enhancements. The test subjects were grade V st

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Thompson, Ian M., Catherine M. Tangen, Eric A. Klein, and Scott M. Lippman. "Phase III Prostate Cancer Prevention Trials: Are the Costs Justified?" Journal of Clinical Oncology 23, no. 32 (2005): 8161–64. http://dx.doi.org/10.1200/jco.2005.02.7987.

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One randomized, prospective clinical trial for chemoprevention of prostate cancer has been completed, and two additional trials are ongoing. The investment, time, and effort for these trials are substantial. We reviewed the outcomes of these trials to address the value of the investment. The outcomes of the Prostate Cancer Prevention Trial (testing finasteride) and the design of the Selenium and Vitamin E Cancer Prevention Trial (SELECT; testing vitamin E and selenium) trial as well as the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial (testing dutasteride) were reviewed. Fr

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Dooley, W. C., J. Parker, and J. Bong. "The effects of clinical trials on improving breast cancer care at a single institution." Journal of Clinical Oncology 29, no. 27_suppl (2011): 198. http://dx.doi.org/10.1200/jco.2011.29.27_suppl.198.

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198 Background: We reported in 2011 at the Society of Surgical Oncology a 19 year retrospective at a single academic institution which identified practice differences between surgical oncologists and general surgeons which were associated with a significant survival advantage. Clinical trial participation was much higher amongst patients treated by a surgical oncologist. Methods: This is an IRB approved, retrospective review of all breast cancer patients receiving primary treatment at a single institution from 1/1/2001 to 12/31/2008. Details of pathology, surgical therapy, chemotherapy, hormon

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Benjamin, Daniel M., Spencer P. Hey, Amanda MacPherson, et al. "Principal investigators over-optimistically forecast scientific and operational outcomes for clinical trials." PLOS ONE 17, no. 2 (2022): e0262862. http://dx.doi.org/10.1371/journal.pone.0262862.

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Objective To assess the accuracy of principal investigators’ (PIs) predictions about three events for their own clinical trials: positivity on trial primary outcomes, successful recruitment and timely trial completion. Study design and setting A short, electronic survey was used to elicit subjective probabilities within seven months of trial registration. When trial results became available, prediction skill was calculated using Brier scores (BS) and compared against uninformative prediction (i.e. predicting 50% all of the time). Results 740 PIs returned surveys (16.7% response rate). Predicti

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Krischak, Madison, Merrick Bank, Mary Byrnes, and Kristian Stensland. "The frequency of use and enrollment impact of patient-centered outcomes in prostate cancer clinical trials." Journal of Clinical Oncology 42, no. 4_suppl (2024): 115. http://dx.doi.org/10.1200/jco.2024.42.4_suppl.115.

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115 Background: Cancer treatments should help patients live either longer or better by improving patient quantity or quality of life. However, some trial endpoints do not correlate with overall survival, and are not noticeable to patients. Selecting endpoints for clinical trials that reflect these goals could improve the discovery process by ensuring trial results are of direct interest to patients, and perhaps by improving enrollment rates to trials. However, how frequently prostate cancer clinical trials use patient-centered outcomes, and how outcome type impacts trial enrollment, is unknown

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Marson, Ben A., Simon Craxford, Sandeep R. Deshmukh, Douglas Grindlay, Joseph Manning, and Benjamin J. Ollivere. "Outcomes reported in trials of childhood fractures." Bone & Joint Open 1, no. 5 (2020): 167–74. http://dx.doi.org/10.1302/2046-3758.15.bjo-2020-0031.

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Aims To analyze outcomes reported in trials of childhood fractures. Methods OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classif

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Marson, Ben A., Simon Craxford, Sandeep R. Deshmukh, Douglas Grindlay, Joseph Manning, and Benjamin J. Ollivere. "Outcomes reported in trials of childhood fractures." Bone & Joint Open 1, no. 5 (2020): 167–74. http://dx.doi.org/10.1302/2633-1462.15.bjo-2020-0031.

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Aims To analyze outcomes reported in trials of childhood fractures. Methods OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classif

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Lamont, Elizabeth B., Mary Beth Landrum, Nancy L. Keating, et al. "Differences in Clinical Trial Patient Attributes and Outcomes According to Enrollment Setting." Journal of Clinical Oncology 28, no. 2 (2010): 215–21. http://dx.doi.org/10.1200/jco.2008.21.3652.

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Purpose During the last 25 years, National Cancer Institute (NCI) cooperative trial groups have extended trial networks from academic centers to include certain community and Veterans Health Administration (VHA) centers. We compared trial patients' attributes and outcomes by these enrollment settings. Patients and Methods Studying 2,708 patients on one of 10 cooperative group, randomized lung trials at 272 institutions, we compared patient attributes by enrollment setting (ie, academic, community, and VHA affiliates). We used adjusted Cox regression to evaluate for survival differences by sett

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Jones, Christopher W., Amanda Adams, Benjamin S. Misemer, et al. "Peer Reviewed Evaluation of Registered End-Points of Randomised Trials (the PRE-REPORT study): a stepped wedge, cluster-randomised trial." BMJ Open 12, no. 9 (2022): e066624. http://dx.doi.org/10.1136/bmjopen-2022-066624.

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Objective To test whether providing relevant clinical trial registry information to peer reviewers evaluating trial manuscripts decreases discrepancies between registered and published trial outcomes. Design Stepped wedge, cluster-randomised trial, with clusters comprised of eligible manuscripts submitted to each participating journal between 1 November 2018 and 31 October 2019. Setting Thirteen medical journals. Participants Manuscripts were eligible for inclusion if they were submitted to a participating journal during the study period, presented results from the primary analysis of a clinic

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Messina, Anthony J., Quentin E. O'Brien, Vasily Andrianov, Keren R. Moss, Laura Vidal, and Liat Vidal-Fisher. "Under Reporting of Patient Reported Outcomes (PROs) in Myeloproliferative Neoplasm (MPN) Clinical Trials." Blood 134, Supplement_1 (2019): 4754. http://dx.doi.org/10.1182/blood-2019-128741.

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Introduction Improvements in overall survival (OS) and quality of life (QoL) are clinically relevant outcomes that should guide clinical decision-making. Patients with MPNs can live with their disease for a long period of time, which increases the importance of understanding the impact of treatment in regards to a patients' Health-Related QoL. Therefore, including PROs in clinical trials has become paramount in facilitating informed treatment decisions made by health care providers and patients. Furthermore, the FDA encourages the implementation of patient-centric measures in clinical trials.

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Bruckner, Till, Daniel Sanchez, Tarik Suljic, et al. "Regulatory gaps and research waste in clinical trials involving women with metastatic breast cancer in Germany." F1000Research 13 (May 1, 2024): 431. http://dx.doi.org/10.12688/f1000research.148958.1.

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Background Non-publication, incomplete publication and excessively slow publication of clinical trial outcomes contribute to research waste and can harm patients. While research waste in German academic trials is well documented, research waste in Germany related to a specific disease area across non-commercial and commercial sponsors has not previously been assessed. Methods In this cohort study, we used public records from three clinical trial registries to identify 70 completed or terminated clinical trials involving women with metastatic breast cancer with trial sites in Germany. We then s

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Mewani, Apeksha. "Using Tokenization and Random Forest Models to Predict Pandemic Trial Outcomes." International Journal of Advanced Engineering, Management and Science 11, no. 2 (2025): 199–205. https://doi.org/10.22161/ijaems.112.18.

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Since the onset of the COVID-19 pandemic, thousands of clinical trials have been launched to evaluate the effectiveness of interventions aimed at preventing or treating the virus. While many of these studies reached completion, a notable proportion were prematurely cessated. Using a comprehensive XML dataset of 5,783 COVID-19 trials registered on ClinicalTrials.gov, we developed a machine learning model to predict whether a trial was likely to be completed or cessated. Our findings, supported by token frequency analysis, highlighted those specific variables, namely the type of intervention and

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Tamiya, Motohiro, Daichi Fujimoto, Akito Hata, et al. "Outcome of chemo-immunotherapy for extensive-stage small-cell lung cancer according to potential clinical trial eligibility: 3-year outcomes from prospective cohort study." Journal of Clinical Oncology 42, no. 16_suppl (2024): 8087. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.8087.

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8087 Background: Chemo-immunotherapy is the standard 1st-line therapy for patients with extensive-stage small-cell lung cancer (ES-SCLC). Our large previous real-world prospective analysis showed outcomes of chemo-immunotherapy for these patients according to potential clinical trial eligibility with a minimum follow-up period of 1 year. However, long-term outcomes have not been studied in the real-world setting. Methods: We conducted a 32-hospital prospective cohort study of consecutive patients with ES-SCLC who received carboplatin and etoposide with atezolizumab as 1st-line therapy between

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Moinpour, Carol M., Andrea M. Denicoff, Deborah Watkins Bruner, et al. "Funding Patient-Reported Outcomes in Cancer Clinical Trials." Journal of Clinical Oncology 25, no. 32 (2007): 5100–5105. http://dx.doi.org/10.1200/jco.2007.11.5329.

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We surveyed four cooperative groups to identify current funding sources for the collection and analysis effort associated with the inclusion of patient-reported outcome (PRO) data in cancer clinical trials. Survey questions included what proportion of staff effort was funded through the Cancer Therapy Evaluation Program (CTEP) and the Community Clinical Oncology Program (CCOP) grants. In addition, the groups were asked to what extent outside funding was solicited to cover an underfunded PRO effort (eg, the pharmaceutical industry, foundations, or National Institutes of Health grants). All four

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Bihari, Shailesh, Andrew Bersten, Eldho Paul, et al. "Acute respiratory distress syndrome phenotypes with distinct clinical outcomes in PHARLA trial cohort." Critical Care and Resuscitation 23, no. 2 (2021): 163–70. http://dx.doi.org/10.51893/2021.2.oa3.

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Background: The Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP) randomised controlled trial compared an open lung ventilation strategy with control ventilation, and found that open lung ventilation did not reduce the number of ventilator-free days (VFDs) or mortality in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Parsimonious models can identify distinct phenotypes of ARDS (hypo-inflammatory and hyperinflammatory) which are associated with different outcomes and treatment responses. Objective: To test the hypothesis that a parsimo

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