Data and safety monitoring in social behavioral intervention trials: The REACH II experience

Clinical Trials

Volumn 3, Issue 2, 2006, Pages 107-118

  Czaja, Sara J ^a   Schulz, Richard ^b   Bell, Steven H ^c   Burgio, Louis D ^d   Armstrong, Nell ^e   Gitlin, Laura N ^f   Coon, David W ^g   Martindale Adams, Jennifer ^h   Klinger, Julie ^b   Stahl, Sidney M ⁱ  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF ALABAMA   (United States)

^e NATIONAL INSTITUTE OF NURSING RESEARCH   (United States)

^f THOMAS JEFFERSON UNIVERSITY   (United States)

^g ARIZONA STATE UNIVERSITY WEST   (United States)

^h UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

ⁱ NATIONAL INSTITUTE ON AGING   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGING; ALZHEIMER DISEASE; ARTICLE; CAREGIVER; HEALTH PROGRAM; HEALTH SURVEY; HUMAN; NURSING; PRIORITY JOURNAL; RISK ASSESSMENT; SOCIAL BEHAVIOR; SOCIAL PSYCHOLOGY;

ALZHEIMER DISEASE; CAREGIVERS; CLINICAL TRIALS DATA MONITORING COMMITTEES; HUMANS; INTERVENTION STUDIES; MULTICENTER STUDIES; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SOCIAL BEHAVIOR;

EID: 33744799684     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1191/1740774506cn136oa     Document Type: Article

References (20)

1. Sydes MR, Spiegelhalter DJ, Altman DG, Babiker AB, Parmar MKB, DAMOCLES Group. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clinical Trials 2004; 1: 60-79.
2. Ellenberg SS. Monitoring data on data monitoring. Clinical Trials 2004; 1: 6-8.
3. NIH Policy for Data and Safety Monitoring. http://grants1.nih.gov/grants/ guide/notice-files/not98-084.html. Access date 10 December 2004.
4. DeMets D, Califf R, Dixon D et al. Issues in regulatory guidelines for data monitory committees. Clinical Trials 2004; 1: 162-69.
5. Interim Guidelines for NIH Intramural Principal Investigators. http://www.nihtraining. com/ohsrsite/irb/attachments/5-10_ serious_adverse_event_rep.htm. Access date 13 December, 2004.
6. Clemens F, Elbourne D, Derbyshire J, Pocock S, DAMOCLES Group. Data monitoring in randomized controlled trials: surveys of recent practice and policies. Clinical Trials 2005; 2: 22-33.
7. Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials: A practical perspective. Wiley, 2003.
8. O'Neill RT. Regulatory perspectives on data monitoring. Statistics in Medicine 2002; 21: 2831-42.
9. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. NEJM 1993; 329: 977-86.
10. Friedman LM, Bristow JD, Hallstrom A et al. Data monitoring in the Cardiac Arrhythmia Suppression Trial. Online Journal of Current Clinical Trials 1993; Doc 79, July 31.
11. Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials, http://grants1.nih.gov/grants/guide/ notice-files/not99-107.html. Access date 14 January, 2005.
12. Fleming ST. Complications, adverse events, and iatrogenesis: Classifications and quality of care measurement issues. Clinical Performance and Quality of Health Care 1996; 4: 137-47.
13. Raisch DW, Troutman WG, Sather MR, Fudala PJ. Variability in the assessment of adverse events in a multicenter clinical trial. Clinical Therapeutics 2001; 23: 2011-20.
14. Folstein MF, Folstein SE, McHugh PR. Mini-mental state: A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189-98.
15. Belle SH, Czaja SJ, Schulz R et al. Using a new taxonomy to combine the uncombinable: Integrating results across diverse caregiving interventions. Psychol Aging 2003; 18: 396-405.
16. Gitlin L, Belle SH, Burgio L et al. Effect of multicomponent interventions on caregiver burden and depression: The REACH multisite initiative at 6-month follow-up. Psychol Aging 2003; 18: 361-74.
17. Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of Alzheimer's Disease caregiving: Prevalence, correlates, and causes. The Gerontologist 1995; 35: 771-91.
18. Schulz R, Belle SH, Czaja SJ, McGinnis KA, Stevens A, Zhang S. Long-term care placement of dementia patients and caregiver health and well-being. JAMA 2004; 292: 961-67.
19. Brass EP. Implementation of a data safety and monitoring plan in a general clinical research center. Journal of Investigative Medicine 2001; 49: 479-85.
20. DAMOCLES Study Group. A proposed charter for clinical trial monitoring committees: helping them do their job well. Lancet 2005; 365: 711-22.