BIOMEDICAL TECHNOLOGY ASSESSMENT;
CANCER SURVIVAL;
DRUG CONTROL;
DRUG INDUSTRY;
DRUG LEGISLATION;
DRUG MONITORING;
DRUG SAFETY;
DRUG SCREENING;
EUROPE;
GOOD CLINICAL PRACTICE;
GOOD MANUFACTURING PRACTICE;
HEALTH CARE ORGANIZATION;
HEALTH CARE PERSONNEL;
INTERNATIONAL COOPERATION;
LUNG NON SMALL CELL CANCER;
MALIGNANT NEOPLASTIC DISEASE;
MEDICAL SERVICE;
MEDICAL SOCIETY;
ONCOLOGY;
OVERALL SURVIVAL;
PATIENT SAFETY;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
PROGRESSION FREE SURVIVAL;
REVIEW;
RISK BENEFIT ANALYSIS;
ANTINEOPLASTIC AGENTS;
DISEASE-FREE SURVIVAL;
DRUG AND NARCOTIC CONTROL;
EUROPEAN UNION;
GOVERNMENT AGENCIES;
HUMANS;
NEOPLASMS;
ORGANIZATIONAL OBJECTIVES;
PRODUCT SURVEILLANCE, POSTMARKETING;
PUBLIC HEALTH;
TECHNOLOGY, PHARMACEUTICAL;
TUMOR MARKERS, BIOLOGICAL;
homepage on the Internet. London: The European Medicines Agency. Available from: accessed on 1 June 2011
European Medicines Agency [homepage on the Internet]. Road map to 2015. London: The European Medicines Agency. 2011. Available from:http://www.ema. europa.eu [accessed on 1 June 2011].
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use [homepage on the Internet]. Geneva: Available from: accessed on 1 June 2011
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use [homepage on the Internet]. E11: Clinical Investigation of Medicinal Products in the Pediatric Population. Geneva: ICH Secretariat. 2000. Available from: http://www.ich.org [accessed on 1 June 2011].
homepage on the Internet. London: European Medicines Agency. Available from: accessed on 1 June 2011
European Medicines Agency [homepage on the Internet]. EMA geriatric medicines strategy. London: European Medicines Agency. 2011. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/Other/2011/02/WC500102291. pdf [accessed on 1 June 2011].
homepage on the Internet]. Brussels: European Commission. Available from: accessed on 1 June 2011
European Commission [homepage on the Internet]. The EU pharmacovigilance system. Brussels: European Commission. 2010. Available from: http://ec.europa.eu/health/human-use/pharmacovigilance/index-en.htm [accessed on 1 June 2011].
[homepage on the Internet]. Available from: accessed on 1 June 2011
PROTECT [homepage on the Internet]. Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium. 2009. Available from: http://www.imi-protect.eu/index.html [accessed on 1 June 2011].
[homepage on the Internet]. London: European Medicines Agency. Available from: accessed on 1 June 2011
European Medicines Agency [homepage on the Internet]. Guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95/Rev.3). London: European Medicines Agency. 2006. Available from: http://www.ema.europa. eu/ema/pages/includes/document/open-document.jsp?webContentId=WC500017748 [accessed on 1 June 2011].
European Medicines Agency [homepage on the Internet]. Available from: accessed on 1 June 2011
European Medicines Agency [homepage on the Internet]. Concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products in man. 2010. Available from: http://www.ema.europa.eu/ema/pages/ includes/document/open-document.jsp?webContentId=WC500096730 [accessed on 1 June 2011].
Evaluating the efficiency of targeted designs for randomized clinical trials
DOI 10.1158/1078-0432.CCR-04-0496
Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004;10:6759-6763 (Pubitemid 39383023)
Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
DOI 10.1158/1078-0432.CCR-05-0605
Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin Cancer Res 2005;11:7872-7878 (Pubitemid 41611633)
Blinded independent central review of progression-free survival in phase III clinical trials: Important design element or unnecessary expense?
Dodd LE, Korn EL, Freidlin B, Jaffe CC, Rubinstein LV, Dancey J, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008;26:3791-3796
Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis
Mar
Amit O, Mannino F, Stone AM, Bushnell W, Denne J, Helterbrand J, et al. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur J Cancer 2011;Mar 21.
Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group
Mar
Stone AM, Bushnell W, Denne J, Sargent DJ, Amit O, Chen C, et al. Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group. Eur J Cancer 2011;Mar 22.
Balancing early market access to new drugs with the need for benefit/risk data: A mounting dilemma
Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 2008;7:818-826
