The unique challenges of enrolling patients into multiple clinical trials

Critical Care Medicine

Volumn 37, Issue SUPPL. 1, 2009, Pages

  Randolph, Adrienne G ^a  

^a BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

Coenrollment; Factorial design; Informed consent; Randomized trial

Indexed keywords

CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL; CRITICAL ILLNESS; DATA ANALYSIS; FACTORIAL DESIGN; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; INTENSIVE CARE; METHODOLOGY; PATIENT PARTICIPATION; PRIORITY JOURNAL; PRODUCTIVITY; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; RISK REDUCTION; ARTICLE; PATIENT SELECTION; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; CRITICAL CARE; DATA INTERPRETATION, STATISTICAL; HUMANS; INFORMED CONSENT; PATIENT SELECTION;

EID: 58849116441     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e3181921c9d     Document Type: Article

References (13)

1. Montgomery AA, Peters TJ, Little P: Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol 2003; 3:26
2. Brookes ST, Whitley E, Peters TJ, et al: Subgroup analyses in randomised controlled trials: Quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001; 5:1-56
3. Green S, Liu PY, O'Sullivan J: Factorial design considerations. J Clin Oncol 2002; 20: 3424-3430
4. McKechnie L, Gill AB: Consent for neonatal research. Arch Dis Child Fetal Neontal Ed 2006; 91:374-376
5. Nuremburg Code. Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law no 10. Vol. 2. Washington DC, US Government Printing Office, 1949, pp 181-182
6. Golec L, Gibbins S, Dunn MS, et al: Informed consent in the NICU setting: An ethically optimal model for research solicitation. J Perinatol 2004; 24:783-791
7. Morley CJ, Lau R, Davis PG, et al: What do parents think about enrolling their premature babies in several research studies? Arch Dis Child Fetal Neonatal Ed 2005; 90:225-228
8. Larntz K, Neaton JD, Wentworth DN, et al: Data analysis issues for protocols with overlapping enrollment. Stat Med 1996; 15:2445-2453
9. Cook DJ, Blythe D, Rischbieth A, et al: Enrolment of intensive care unit patients into clinical studies: A trinational survey of researchers' experiences, beliefs, and practices. Crit Care Med 2008; 36:2100-2105
10. The Acute Respiratory Distress Syndrome Network: Ketaconazole for early treatment of acute lung injury and Acute Respiratory Distress Syndrome. A randomized trial. JAMA 2000; 283:1995-2002
11. The Acute Respiratory Distress Syndrome Network: Ventilation with lower tidal volume as compared to traditional tidal volumes for acute lung injury and acute respiratory distress syndrome. N Engl J Med 2000; 342: 1301-1308
12. The Acute Respiratory Distress Syndrome Network: Comparison of two fluid management strategies in acute lung injury. N Engl J Med 2006; 354:2564-2575
13. The Acute Respiratory Distress Syndrome Network: Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury. N Engl J Med 2006; 354: 2213-2224