R. Pazdur, Endpoints for Assessing Drug Activity in Clinical Trials, The Oncologist. 1 avr, vol.13, pp.19-21, 2008.
DOI : 10.1634/theoncologist.13-s2-19
URL : http://theoncologist.alphamedpress.org/content/13/suppl_2/19.full.pdf

J. Fetting, P. Anderson, H. Ball, J. Benear, K. Benjamin et al., Outcomes of cancer treatment for technology assessment and cancer treatment guidelines, J Clin Oncol. févr, vol.14, issue.2, pp.671-680, 1996.

, End Points and United States Food and Drug Administration Approval of Oncology Drugs, Journal of Clinical Oncology, vol.21, issue.7, p.13, 2017.

D. Sur,

B. Chibaudel, F. Bonnetain, Q. Shi, M. Buyse, C. Tournigand et al., Alternative End Points to Evaluate a Therapeutic Strategy in Advanced Colorectal Cancer: Evaluation of Progression-Free Survival, Duration of Disease Control, and Time to Failure of Strategy-An Aide et Recherche en Cancérologie Digestive Group Study, Journal of Clinical Oncology, vol.29, issue.31, p.13, 2011.

C. Punt, M. Buyse, C. Köhne, P. Hohenberger, R. Labianca et al.,

, Endpoints in Adjuvant Treatment Trials: A Systematic Review of the Literature in Colon Cancer and Proposed Definitions for Future Trials, JNCI J Natl Cancer Inst, vol.99, issue.13, pp.998-1003, 2007.

B. D. Cheson, The International Harmonization Project for Response Criteria in Lymphoma Clinical Trials, Hematol Oncol Clin North Am, vol.21, issue.5, pp.841-54, 2007.

M. E. Juweid, G. A. Wiseman, J. M. Vose, J. M. Ritchie, Y. Menda et al.,

, Response Assessment of Aggressive Non-Hodgkin's Lymphoma by Integrated International Workshop Criteria and Fluorine-18-Fluorodeoxyglucose Positron Emission Tomography, J Clin Oncol. 20 juill, vol.23, issue.21, pp.4652-61, 2005.

S. Mathoulin-pelissier, S. Gourgou-bourgade, F. Bonnetain, and A. Kramar, Survival End Point Reporting in Randomized Cancer Clinical Trials: A Review of Major Journals, J Clin Oncol. 1 août, vol.26, issue.22, pp.3721-3727, 2008.

B. Chibaudel, F. Bonnetain, C. Tournigand, M. H. De-larauze, A. De-gramont et al., STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer, BMC Cancer. 4 juill, vol.15, p.496, 2015.
URL : https://hal.archives-ouvertes.fr/hal-01211687

F. Bonnetain, B. Bonsing, T. Conroy, A. Dousseau, B. Glimelius et al., Guidelines for time-to-event end-point definitions in trials for pancreatic cancer
URL : https://hal.archives-ouvertes.fr/hal-01802621

, Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials), Eur J Cancer, vol.50, issue.17, pp.2983-93, 2014.

C. A. Bellera, N. Penel, M. Ouali, S. Bonvalot, P. G. Casali et al., Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Timeto-event Endpoints in CANcer trials), Ann Oncol. 1 mai, vol.26, issue.5, pp.865-72, 2015.

A. Kramar, S. Negrier, R. Sylvester, S. Joniau, P. Mulders et al., Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project, Ann Oncol. 1 déc, vol.26, issue.12, pp.2392-2400, 2015.
URL : https://hal.archives-ouvertes.fr/hal-01913181

S. Gourgou-bourgade, D. Cameron, P. Poortmans, B. Asselain, D. Azria et al., Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials), Ann Oncol. 1 mai, vol.26, issue.5, pp.873-882, 2015.

M. Buyse, G. Molenberghs, T. Burzykowski, R. D. Geys, and H. , The validation of surrogate endpoints in meta-analyses of randomized experiments, Biostatistics. 1 mars, vol.1, issue.1, pp.49-67, 2000.

G. Molenberghs, M. Buyse, H. Geys, R. D. Burzykowski, T. Alonso et al., Statistical challenges in the evaluation of surrogate endpoints in randomized trials, Control Clin Trials. 1 déc, vol.23, issue.6, pp.607-632, 2002.

P. B. Gilbert, E. E. Gabriel, Y. Huang, and I. Chan, Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition, J Causal Inference. 1 sept, vol.3, issue.2, pp.157-75, 2015.
DOI : 10.1515/jci-2014-0007
URL : http://www.degruyter.com/downloadpdf/j/jci.2015.3.issue-2/jci-2014-0007/jci-2014-0007.xml

M. Co-primary-endpoints, Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of AmericaTherapeutic Innovation & Regulatory Science -Walter Offen, Christy ChuangStein

A. Stryszak, K. Baddy, K. Chen, W. Copley-merriman, S. Dere et al., , p.10, 2007.

M. Neuhäuser, How to deal with multiple endpoints in clinical trials, Fundam. Clin. Pharmacol, vol.20, pp.515-523, 2006.

C. Chuang-stein, P. Stryszak, A. Dmitrienko, and W. Offen, Challenge of multiple co-primary endpoints: a new approach, Stat. Med, vol.26, pp.1181-1192, 2007.
DOI : 10.1002/sim.2604

H. M. Hung and S. Wang, Some Controversial Multiple Testing Problems in Regulatory Applications, J. Biopharm. Stat, vol.19, pp.1-11, 2009.
DOI : 10.1080/10543400802541693

. Wiley, Design and Analysis of Clinical Trials: Concepts and Methodologies

D. A. Schoenfeld, Sample-size formula for the proportional-hazards regression model, Biometrics, vol.39, pp.499-503, 1983.
DOI : 10.2307/2531021

P. Moffett and G. Moore, The Standard of Care: Legal History and Definitions: the Bad and Good News, West. J. Emerg. Med, vol.12, pp.109-112, 2011.

K. Kim and A. A. Tsiatis, Study duration for clinical trials with survival response and early stopping rule, Biometrics, vol.46, pp.81-92, 1990.

P. Armitage, C. K. Mcpherson, and B. C. Rowe, Repeated Significance Tests on Accumulating Data, J. R. Stat. Soc. Ser. Gen, vol.132, pp.235-244, 1969.
DOI : 10.2307/2343787

C. Burman, C. Sonesson, and O. Guilbaud, A recycling framework for the construction of Bonferroni-based multiple tests, Stat. Med, vol.28, pp.739-761, 2009.

A. Dmitrienko, B. L. Wiens, A. C. Tamhane, and X. Wang, Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives, Stat. Med, vol.26, pp.2465-2478, 2007.

S. Todd, A. Whitehead, N. Stallard, and J. Whitehead, Interim analyses and sequential designs in phase III studies, Br. J. Clin. Pharmacol, vol.51, pp.394-399, 2001.

, Group Sequential Methods with Applications to Clinical Trials, 1999.

S. Todd, A. Whitehead, N. Stallard, and J. Whitehead, Interim analyses and sequential designs in phase III studies, Br. J. Clin. Pharmacol, vol.51, pp.394-399, 2001.

T. Filleron, J. Gal, and A. Kramar, Designing Group Sequential Randomized Clinical Trials with Time to Event End Points Using a R Function, Comput Methods Prog Biomed, vol.108, pp.113-128, 2012.

S. J. Pocock, Interim Analyses for Randomized Clinical Trials: The Group Sequential Approach, Biometrics, vol.38, pp.153-162, 1982.

P. C. O'brien and T. R. Fleming, A multiple testing procedure for clinical trials, Biometrics, vol.35, pp.549-556, 1979.

T. Filleron, J. Gal, and A. Kramar, Designing group sequential randomized clinical trials with time to event end points using a R function, Comput. Methods Programs Biomed, vol.108, pp.113-128, 2012.

A. Anota, Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?, Qual. Life Res, vol.24, pp.5-18, 2015.

U. R. Abel, Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas, Journal of Biopharmaceutical Statistics, vol.25, issue.6, pp.1285-311, 2015.

A. Anota and G. Mouillet, « Sequential FOLFIRI.3 + Gemcitabine Improves HealthRelated Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial, PloS One, vol.10, issue.5, p.125350, 2015.

. Pubmed,

A. Anota and Z. Hamidou, Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?, Quality of Life Research, vol.24, pp.5-18, 2015.

J. Beitz, Quality-of-Life End Points in Cancer Clinical Trials: The U.S. Food and Drug Administration Perspective », Journal of the National Cancer Institute. Monographs, vol.20, pp.7-9, 1996.

C. A. Bellera, Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials), Annals of Oncology, vol.26, issue.5, pp.865-72, 2015.
URL : https://hal.archives-ouvertes.fr/hal-01912106

B. Bergman, A Modular Supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for Use in Lung Cancer Clinical Trials. EORTC Study Group on Quality of Life, European Journal of Cancer, vol.30, issue.5, pp.635-677, 1990.

J. Bland, D. G. Martin, and . Altman, « The logrank test, BMJ : British Medical Journal, vol.328, p.1073, 2004.

G. M. Blumenthal, Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies, The Oncologist, vol.22, issue.7, pp.762-67, 2017.

, PubMed Central

F. Bonnetain, Qualité de vie relative à la santé et critères de jugement en cancérologie, Cancer Radiother, pp.515-533, 2010.

F. Bonnetain and B. Bonsing, Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials), European Journal of Cancer, vol.50, pp.2983-93, 2014.
URL : https://hal.archives-ouvertes.fr/hal-01802621

F. Bonnetain and F. Fiteni, Statistical Challenges in the Analysis of Health-Related Quality of Life in Cancer Clinical Trials, Journal of Clinical Oncology, vol.34, pp.1953-56, 2016.

F. Bonnetain and L. Dahan, Time until Definitive Quality of Life Score Deterioration as a Means of Longitudinal Analysis for Treatment Trials in Patients with Metastatic Pancreatic Adenocarcinoma, European Journal of Cancer, vol.46, pp.2753-62, 1990.

A. Bottomley, Analysing Data from Patient-Reported Outcome and Quality of Life Endpoints for Cancer Clinical Trials: A Start in Setting International Standards, The Lancet. Oncology, vol.17, issue.11, pp.510-524, 2016.

T. Burzykowski, Validation of Surrogate End Points in Multiple Randomized Clinical Trials with Failure Time End Points, vol.50, pp.405-427, 2001.

M. Buyse, « The Validation of Surrogate Endpoints in Meta-Analyses of Randomized Experiments, Biostatistics, vol.1, issue.1, pp.49-67, 2000.

, biostatistics.oxfordjournals.org

M. Calvert, Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension, JAMA, vol.309, issue.8, pp.814-836, 2013.

C. Chuang-stein, Challenge of Multiple Co-Primary Endpoints: A New Approach », Statistics in Medicine, vol.26, pp.1181-92, 2007.

C. Cox and . Fieller, s Theorem, the Likelihood and the Delta Method, Biometrics, vol.46, issue.3, pp.709-727, 1990.

A. Dmitrienko, « Tree-Structured Gatekeeping Tests in Clinical Trials with Hierarchically Ordered Multiple Objectives, Statistics in Medicine, vol.26, pp.2465-78, 2007.

. Pubmed,

E. A. Eisenhauer, New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (Version 1.1), European Journal of Cancer, vol.45, issue.2, pp.228-275, 1990.

P. M. Fayers, EORTC QLQ-C30 scoring manual, vol.11, p.146, 2001.

F. Fiteni, Health-Related Quality-of-Life as Co-Primary Endpoint in Randomized Clinical Trials in Oncology, Expert Review of Anticancer Therapy, vol.15, issue.8, pp.885-91, 2015.

. Pubmed,

J. L. Fleiss, The Statistical Basis of Meta-Analysis, Statistical Methods in Medical Research, vol.2, issue.2, pp.121-166, 1993.

T. R. Fleming, H. Et-john, . Powers, S. Biomarkers, and . Endpoints, Clinical Trials ». Statistics in medicine, vol.31, pp.2973-84, 2012.

L. S. Freedman, « Statistical Validation of Intermediate Endpoints for Chronic Diseases, Statistics in Medicine, vol.11, issue.2, pp.167-78, 1992.

M. H. Gail and . Sample, Size Estimation When Time-to-Event Is the Primary Endpoint, Drug Information Journal, vol.28, issue.3, pp.865-77, 1994.

|. Glossary and . Eortc,

C. C. Gotay, The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials, Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, vol.26, issue.8, pp.1355-63, 2008.

C. Gotay and . Cook, Quality-of-Life Assessment in Cancer Treatment Protocols: Research Issues in Protocol Development, JNCI: Journal of the National Cancer Institute, vol.84, issue.8, pp.575-79, 1992.

S. Gourgou-bourgade, Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials), Annals of Oncology, vol.26, issue.5, pp.873-79, 2015.
URL : https://hal.archives-ouvertes.fr/hal-02284722

,

Z. Hamidou, Time to Deterioration in Quality of Life Score as a Modality of Longitudinal Analysis in Patients with Breast Cancer, The Oncologist, vol.16, issue.10, pp.1458-68, 2011.
URL : https://hal.archives-ouvertes.fr/hal-00687536

R. Kemp and V. Prasad, « Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?, PubMed Central, vol.15, 2017.

A. Kramar, Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project, Annals of Oncology, vol.26, pp.2392-98, 2015.
URL : https://hal.archives-ouvertes.fr/hal-01913181

N. Mantel, Evaluation of Survival Data and Two New Rank Order Statistics Arising in Its Consideration, Cancer Chemotherapy Reports, vol.50, issue.3, pp.163-70, 1966.

. Mathoulin-pelissier and . Simone, Survival End Point Reporting in Randomized Cancer Clinical Trials: A Review of Major Journals, vol.26, pp.3721-3747, 2008.

M. L. Mchugh and . Interrater-reliability, The Kappa Statistic, vol.22, pp.276-82, 2012.

N. Methy, Surrogate Endpoints for Overall Survival in Digestive Oncology Trials: Which Candidates? A Questionnaires Survey among Clinicians and Methodologists, europepmc.org, vol.10, pp.277-277, 2010.
URL : https://hal.archives-ouvertes.fr/inserm-00668453

C. Moinpour and . Mcmillen, Quality of Life End Points in Cancer Clinical Trials: Review and Recommendations, JNCI: Journal of the National Cancer Institute, vol.81, issue.7, pp.485-96, 1989.

G. Molenberghs, « Statistical challenges in the evaluation of surrogate endpoints in randomized trials, Controlled Clinical Trials, vol.23, issue.6, pp.607-632, 2002.

. Sciencedirect,

M. Co-primary-endpoints, Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of AmericaTherapeutic Innovation & Regulatory Science -Walter Offen, Christy ChuangStein

A. Stryszak, K. Baddy, K. Chen, W. Copley-merriman, S. Dere et al., , 2007.

,

M. Neuhäuser, « How to Deal with Multiple Endpoints, Clinical Trials ». Fundamental & Clinical Pharmacology, vol.20, issue.6, pp.515-538, 2006.

R. Pazdur, Endpoints for Assessing Drug Activity in Clinical Trials, vol.13, pp.19-21, 2008.

, Endpoints for Assessing Drug Activity in Clinical Trials, vol.13, pp.19-21, 2008.

J. M. Peppercorn, American Society of Clinical Oncology Statement: Toward Individualized Care for Patients with Advanced Cancer, Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, vol.29, issue.6, pp.755-60, 2011.

. Pubmed,

S. J. Pocock, « Interim Analyses for Randomized Clinical Trials: The Group Sequential Approach, Biometrics, vol.38, issue.1, pp.153-62, 1982.

R. L. Prentice, Surrogate Endpoints in Clinical Trials: Definition and Operational Criteria, Statistics in Medicine, vol.8, issue.4, pp.431-471, 1989.

E. P. Rock, « Food and Drug Administration Drug Approval Summary: Sunitinib Malate for the Treatment of Gastrointestinal Stromal Tumor and Advanced Renal Cell Carcinoma, The Oncologist, vol.12, pp.107-120, 2007.

«. Sample, Size Calculations in Clinical Research, 2007.

N. Sartorius and . Who, Method for the Assessment of Health-Related Quality of Life (WHOQOL) ». Quality of Life Assessment: Key Issues in the 1990s, link.springer.com, pp.201-208, 1993.

D. A. Schoenfeld and . Sample, Size Formula for the Proportional-Hazards Regression Model, Biometrics, vol.39, issue.2, pp.499-503, 1983.

K. F. Schulz, Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials, Clinical Research Ed.), vol.340, p.332, 2010.

S. Senn, Some Controversies in Planning and Analysing Multi-Centre Trials, vol.17, pp.1753-65, 1998.

S. G. Thompson, Controversies in Meta-Analysis: The Case of the Trials of Serum Cholesterol Reduction, Statistical Methods in Medical Research, vol.2, issue.2, pp.173-92, 1993.

S. G. Thompson and S. J. Pocock, « Can Meta-Analyses Be Trusted?, Lancet, vol.338, pp.1127-1157, 1991.

P. Velentgas, Outcome Definition and Measurement. Agency for Healthcare Research and Quality (US), 2013.

W. S. Weintraub, « The perils of surrogate endpoints, European Heart Journal, vol.36, pp.2212-2230, 2015.

«. Who-|, Constitution of WHO

, World Medical Association. « World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects ». JAMA, vol.310, pp.2191-94, 2013.

, Méthodes biostatistiques appliquées à la recherche clinique en cancérologie