Clinical Trials

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  Publication Venue For

  • Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program..  1740774519836766. 2019
  • Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study..  1740774519829695. 2019
  • Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease..  16:20-31. 2019
  • FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial..  16:90-97. 2019
  • The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials.  16:3-10. 2019
  • Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST)..  15:268-277. 2018
  • Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov..  15:87-94. 2018
  • The Clinical Trials Transformation Initiative: Looking back, looking forward..  15:3-4. 2018
  • The Clinical Trials Transformation Initiative: Methodology supporting the mission..  15:13-18. 2018
  • Design of a randomized clinical trial of a colorectal cancer screening decision aid to promote appropriate screening in community-dwelling older adults..  14:648-658. 2017
  • Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative..  14:342-348. 2017
  • Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE..  14:255-263. 2017
  • Data monitoring committees: Promoting best practices to address emerging challenges..  14:115-123. 2017
  • Rejoinder..  14:126-127. 2017
  • The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study..  14:128-139. 2017
  • Comparison of futility monitoring guidelines using completed phase III oncology trials..  14:48-58. 2017
  • Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings..  14:88-93. 2017
  • The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance..  14:29-36. 2017
  • Response..  13:568-569. 2016
  • Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core..  13:504-512. 2016
  • University of Pennsylvania eighth annual conference on statistical issues in clinical trials: Pragmatic clinical trials (afternoon panel)..  13:527-536. 2016
  • Alignment of site versus adjudication committee-based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial..  13:140-148. 2016
  • Commentary on Sertkaya et al. and Larson et al..  13:137-139. 2016
  • Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial..  12:634-645. 2015
  • Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials..  12:476-484. 2015
  • Harms, benefits, and the nature of interventions in pragmatic clinical trials..  12:467-475. 2015
  • The Food and Drug Administration and pragmatic clinical trials of marketed medical products..  12:511-519. 2015
  • Use of altered informed consent in pragmatic clinical research..  12:494-502. 2015
  • A multi-site randomized clinical trial to reduce suicidal ideation in suicidal adult outpatients with Major Depressive Disorder: Development of a methodology to enhance safety..  12:189-198. 2015
  • Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems..  12:276-286. 2015
  • Commentary on Vickers..  11:626-627. 2014
  • Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation..  11:560-564. 2014
  • Organizational and physician factors associated with patient enrollment in cancer clinical trials..  11:565-575. 2014
  • Attitudes toward clinical trials among patients with sickle cell disease..  11:275-283. 2014
  • Bumps and bridges on the road to responsible sharing of clinical trial data..  11:7-12. 2014
  • The National Drug Abuse Treatment Clinical Trials Network Data Share project: Website design, usage, challenges, and future directions.  10:977-986. 2013
  • Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents..  10:604-611. 2013
  • Participants' perspectives on safety monitoring in clinical trials..  10:552-559. 2013
  • 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..  10:319-331. 2013
  • Panel discussion 1..  9:696-704. 2012
  • A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials..  9:426-435. 2012
  • Analysis of combined data from heterogeneous study designs: an applied example from the patient navigation research program..  9:176-187. 2012
  • Organizational- and employee-level recruitment into a worksite-based weight loss study..  9:215-225. 2012
  • Commentary on Anand et al..  8:724-726. 2011
  • Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials..  8:591-600. 2011
  • Monitoring the quality of conduct of clinical trials: a survey of current practices..  8:342-349. 2011
  • Development of adherence metrics for caloric restriction interventions..  8:155-164. 2011
  • Design and implementation of an institutional case report form library..  8:94-102. 2011
  • Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group..  7:322-332. 2010
  • Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials..  7:312-321. 2010
  • Caregiver-assisted coping skills training for patients with COPD: background, design, and methodological issues for the INSPIRE-II study..  6:172-184. 2009
  • Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods..  6:162-171. 2009
  • What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997--2006..  6:141-150. 2009
  • A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network..  6:67-75. 2009
  • Authors' response.  5:223-224. 2008
  • Erratum: Meta-analysis of rare events: An update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone (Clinical Trials (2008) vol. 5(2) (116-20) 10.1177/1740774508090212).  5:559. 2008
  • Response to letter of Meinert et al.  5:558. 2008
  • Comment regarding benefit in phase 1 oncology trials..  5:626-630. 2008
  • Design considerations and rationale of a multi-center trial to sustain weight loss: the Weight Loss Maintenance Trial..  5:546-556. 2008
  • Designing phase II studies in cancer with time-to-event endpoints..  5:209-221. 2008
  • Do we need to adjudicate major clinical events?.  5:56-60. 2008
  • Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone..  5:116-120. 2008
  • Overcoming challenges in designing and implementing a phase II randomized controlled trial using a presurgical model to test a dietary intervention in prostate cancer..  5:262-272. 2008
  • Reformulating the hazard ratio to enhance communication with clinical investigators..  5:248-252. 2008
  • Sensible approaches for reducing clinical trial costs..  5:75-84. 2008
  • Sensible guidelines for the conduct of large randomized trials..  5:38-39. 2008
  • The impact of privacy and confidentiality laws on the conduct of clinical trials..  5:70-74. 2008
  • Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions..  5:575-586. 2008
  • Varieties of uncertainty and the validity of informed consent..  5:624-630. 2008
  • A study design to assess the safety and efficacy of on-pump versus off-pump coronary bypass grafting: the ROOBY trial..  4:81-91. 2007
  • Integrating smoking cessation into mental health care for post-traumatic stress disorder..  4:178-189. 2007
  • Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board..  4:218-234. 2007
  • Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial..  4:92-101. 2007
  • Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants..  4:272-278. 2007
  • Understanding prognostic benefits of exercise and antidepressant therapy for persons with depression and heart disease: the UPBEAT study--rationale, design, and methodological issues..  4:548-559. 2007
  • Who refuses enrollment in cardiac clinical trials?.  4:258-263. 2007
  • Erratum: Design of the Dialysis Access Consortium (DAC) aggrenox prevention of access stenosis trial (Clinical Trials 2 (400-412)).  3:160. 2006
  • Clinical trials bureaucracy: unintended consequences of well-intentioned policy..  3:496-502. 2006
  • Comparing an experimental agent to a standard agent: relative merits of a one-arm or randomized two-arm Phase II design..  3:335-348. 2006
  • Cost-effectiveness as an outcome in randomized clinical trials..  3:543-551. 2006
  • Equipoise in the Enhanced Supression of the Platelet IIb/IIIa Receptor with Integrilin Trial (ESPRIT): A critical appraisal. Comment.  2:242-243. 2005
  • A general formulation for a one-sided group sequential design..  2:519-528. 2005
  • An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial..  2:80-87. 2005
  • Design of the Dialysis Access Consortium (DAC) Aggrenox Prevention Of Access Stenosis Trial..  2:400-412. 2005
  • Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial..  2:413-422. 2005
  • The Society for Clinical Trials supports United States legislation mandating trials registration..  2:193. 2005
  • Issues in regulatory guidelines for data monitoring committees..  1:162-169. 2004
  • Liability issues for data monitoring committee members..  1:525-531. 2004
  • The Society for Clinical Trials supports United States legislation mandating trials registration. Position paper..  1:417-420. 2004
  • Panel discussion of case study 3 2005