Protecting the confidentiality of interim data: Addressing current challenges

Clinical Trials

Volumn 12, Issue 1, 2015, Pages 5-11

  Fleming, Thomas R ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Cardiovascular safety trials; Data access plan; Data monitoring committee; Performance standards document

Indexed keywords

ADVERSE OUTCOME; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CAREGIVER; CONFIDENTIALITY; HUMAN; MEDICAL DECISION MAKING; MEDICAL INFORMATION; MORBIDITY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW; ANONYMIZATION; CLINICAL TRIAL (TOPIC); DECISION MAKING; FEMALE; MALE; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PROCEDURES; PROFESSIONAL STANDARD; RISK FACTOR; STANDARDS;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA ANONYMIZATION; DECISION MAKING; FEMALE; HUMANS; MALE; RESEARCH DESIGN; RISK FACTORS;

EID: 84922374669     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514561243     Document Type: Review

References (18)

1. Ellenberg S, Fleming T and DeMets D. Data monitoring committees in clinical trials: a practical perspective. West Sussex: John Wiley & Sons, Ltd, 2002.
2. Fleming TR, Sharples K, McCall J, et al. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials 2008; 5: 157-167.
3. Fleming TR, Hennekens CH, Pfeffer MA, et al. Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials. J Biopharm Stat 2014; 24: 968-975.
4. Grant AM, Altman DG, Babiker AB, et al. Issues in data monitoring and interim analyses of trials. Health Technol Assess 2005; 9: 1-238.
5. Green SJ, Fleming TR and O'Fallon JR. Policies for study monitoring and interim reporting of results. J Clin Oncol 1987; 5: 2477-2484.
6. Abrams DI, Goldman AI, Launer C, et al. A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection. N Engl J Med 1994; 330: 657-662.
7. Fleming TR, Neaton JD, Goldman A, et al. Insights from monitoring the CPCRA didanosine/zalcitabine trial. J Acquir Immune Defic Syndr Hum Retrovirol 1995; 10(Suppl. 2): S9-S18.
8. National Institutes of Health. Policy for data and safety monitoring, http://grants.nih.gov/grants/guide/notice-files/not98-084.html (accessed 19 February 2007).
9. World Health Organization. Operational guidelines for the establishment and functioning of data and safety monitoring boards, 2005. http://osp.od.nih.gov/sites/default/files/resources/operational-guidelines.pdf (accessed 23 November 2014).
10. European Medicines Agency and Committee for Medicinal Products for Human Use. Guideline on data monitoring committees, 2005. http://www.emea.eu.int/pdfs/human/ewp/587203en.pdf (accessed 23 November 2014).
11. US Food and Drug Administration. Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees, 2005. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf (accessed 23 November 2014).
12. O'Brien PC and Fleming TR. A multi-stage procedure for clinical trials. Biometrics 1979; 35: 549-556.
13. Besarab A, Bolton WK, Browne JK, et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998; 339: 584-590.
14. Lan KKG and DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-663.
15. Guidance for industry. Diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes, 2008. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf (accessed 23 November 2014).
16. Fleming TR. Identifying and addressing safety signals in clinical trials: some issues and challenges. In: Fleming TR and Weir BS (eds) Proceedings of the 4th Seattle Symposium in Biostatistics: Clinical Trials. New York: Springer, 2013, pp. 137-156.
17. Fleming TR. Identifying and addressing safety signals in clinical trials. N Engl J Med 2008; 359: 1400-1402.
18. Fleming TR. Addressing missing data in clinical trials. Ann Intern Med 2011; 154: 113-117.