Regulatory reply to the ATMOSPHERE data monitoring committee

New England Journal of Medicine

Volumn 374, Issue 16, 2016, Pages 1585-1586

  Salmonson, Tomas ^a   Janssen, Heidi ^b   Sudhop, Thomas ^c   Stahl, Elke ^c  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALISKIREN; ANGIOTENSIN RECEPTOR ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; AMIDE; FUMARIC ACID DERIVATIVE;

ACUTE HEART FAILURE; CLINICAL TRIAL (TOPIC); DIABETES MELLITUS; DRUG CONTRAINDICATION; DRUG SAFETY; HUMAN; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; KIDNEY DYSFUNCTION; LETTER; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RESPONSIBILITY; RISK BENEFIT ANALYSIS; SAFETY; DIABETES MELLITUS, TYPE 2; RANDOMIZED CONTROLLED TRIAL (TOPIC);

AMIDES; CLINICAL TRIALS DATA MONITORING COMMITTEES; DIABETES MELLITUS, TYPE 2; FUMARATES; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84964440151     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1603514     Document Type: Letter

References (3)

1. Swedberg K, Borer JS, Pitt B, Pocock S, Rouleau J. Challenges to data monitoring committees when regulatory authorities intervene. N Eng J Med 2016; 374: xx-xx.
2. Committee for Medicinal Products for Human Use. Guideline on data monitoring committees. London: European MedicinesAgency, 2005 (http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003635.pdf).
3. Rasilez: European public assessment report. London: European Medicines Agency. February 24, 2016 (http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000780/human-med-001013.jsp&mid=WC0b01ac058001d124).