References
- Booth CM, Karim S, Mackillop WJ. Real-world data: towards achieving the achievable in cancer care. Nat Rev Clin Oncol. 2019;16(5):312–325. doi:https://doi.org/10.1038/s41571-019-0167-7.
- Carmona-Bayonas A, Jiménez-Fonseca P, Gallego J, Msaouel P. Causal considerations can inform the interpretation of surprising associations in medical registries. Cancer Invest. 2021;2021:1–13. doi:https://doi.org/10.1080/07357907.2021.1999971.
- Msaouel P. Impervious to randomness: confounding and selection biases in randomized clinical trials. Cancer Invest. 2021;39(10):783–788. doi:https://doi.org/10.1080/07357907.2021.1974030.
- Msaouel P, Lee J, Thall PF. Making patient-specific treatment decisions using prognostic variables and utilities of clinical outcomes. Cancers. 2021;13(11):2741. doi:https://doi.org/10.3390/cancers13112741.
- Msaouel P, Grivas P, Zhang T. Adjuvant systemic therapies for patients with renal cell carcinoma: choosing treatment based on patient-level characteristics. Eur Urol Oncol. 2021;2021:3. doi:https://doi.org/10.1016/j.euo.2021.09.003.
- Gluud LL. Bias in clinical intervention research. Am J Epidemiol. 2006;163(6):493–501. doi:https://doi.org/10.1093/aje/kwj069.
- Isbary G, Staab TR, Amelung VE, Dintsios C-M, Iking-Konert C, Nesurini SM, et al. Effect of crossover in oncology clinical trials on evidence levels in early benefit assessment in Germany. Value Health. 2018;21(6):698–706. doi:https://doi.org/10.1016/j.jval.2017.09.010.
- Zhang J, Chen C. Correcting treatment effect for treatment switching in randomized oncology trials with a modified iterative parametric estimation method. Stat Med. 2016;35(21):3690–3703. doi:https://doi.org/10.1002/sim.6923.
- Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(6):796–807. doi:https://doi.org/10.1016/S1470-2045(20)30157-1.
- Watkins C, Huang X, Latimer N, Tang Y, Wright EJ. Adjusting overall survival for treatment switches: commonly used methods and practical application. Pharm Stat. 2013;12(6):348–357. doi:https://doi.org/10.1002/pst.1602.
- Fojo T, Amiri-Kordestani L, Bates SE. Potential pitfalls of crossover and thoughts on iniparib in triple-negative breast cancer. J Natl Cancer Inst. 2011;103(23):1738–1740. doi:https://doi.org/10.1093/jnci/djr386.
- O’Shaughnessy J, Osborne C, Pippen JE, Yoffe M, Patt D, Rocha C, et al. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med. 2011;364(3):205–214. doi:https://doi.org/10.1056/NEJMoa1011418.
- Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016;388(10043):488–497. doi:https://doi.org/10.1016/S0140-6736(16)30587-6.
- Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, et al. Effect of doxorubicin plus olaratumab vs doxorubicin plus placebo on survival in patients with advanced soft tissue sarcomas: the ANNOUNCE randomized clinical trial. JAMA. 2020;323(13):1266–1276. doi:https://doi.org/10.1001/jama.2020.1707.
- Harden JJ, Kropko J. Simulating duration data for the cox model. Polit Sci Res Meth. 2019;7(04):921–928. doi:https://doi.org/10.1017/psrm.2018.19.
- Altman DG. Statistics and ethics in medical research. Misuse of statistics is unethical. Br Med J. 1980;281(6249):1182–1184. doi:https://doi.org/10.1136/bmj.281.6249.1182.
- Berry DA. Bayesian statistics and the efficiency and ethics of clinical trials. Statist Sci. 2004;19(1):175–187. doi:https://doi.org/10.1214/088342304000000044.