Clinical Trials

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  Publication Venue For

  • Five analytic challenges in working with electronic health records data to support clinical trials with some solutions..  1740774520931211. 2020
  • Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial..  1740774520928426. 2020
  • Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents..  10:604-611. 2013
  • Organizational- and employee-level recruitment into a worksite-based weight loss study..  9:215-225. 2012
  • 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
  • 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. 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..  5:624-625. 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
  • Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD)..  3:443-456. 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