US Food and Drug Administration
The International Council for Harmonisation
Chen, 2020, FDA acceptance of surrogate end points for cancer drug approval: 1992-2019, JAMA Intern Med, 180, 912, 10.1001/jamainternmed.2020.1097
Meyers, 2021, Evaluation of the clinical benefit of cancer drugs submitted for reimbursement recommendation decisions in Canada, JAMA Intern Med, 181, 499, 10.1001/jamainternmed.2020.8588
Mushti, 2018, Evaluation of overall response rate and progression-free survival as potential surrogate endpoints for overall survival in immunotherapy trials, Clin Cancer Res, 24, 2268, 10.1158/1078-0432.CCR-17-1902
Kok, 2021, Tumor response end points as surrogates for overall survival in immune checkpoint inhibitor trials: a systematic review and meta-analysis, JCO Precis Oncol, 5
Zhang, 2019, Endpoint surrogacy in oncological randomized controlled trials with immunotherapies: a systematic review of trial-level and arm-level meta-analyses, Ann Transl Med, 7, 244, 10.21037/atm.2019.04.72
Yin, 2022, Reevaluating disease-free survival as an endpoint vs overall survival in stage III adjuvant colon cancer trials, J Natl Cancer Inst, 114, 60, 10.1093/jnci/djab187
McDermott, 2021, Remote research and clinical trial integrity during and after the coronavirus pandemic, JAMA, 325, 1935, 10.1001/jama.2021.4609
Thacker, 2021, Covid-19: researcher blows the whistle on data integrity issues in Pfizer's vaccine trial, BMJ, 375, n2635, 10.1136/bmj.n2635
Tang, 2022, Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis, Contemp Clin Trials, 116, 10.1016/j.cct.2022.106736
Waterhouse, 2020, Early impact of COVID-19 on the conduct of oncology clinical trials and long-term opportunities for transformation: findings from an American society of clinical oncology survey, JCO Oncol Pract, 16, 417, 10.1200/OP.20.00275
Del Paggio, 2019, The fragility of phase 3 trials supporting FDA-approved anticancer medicines: a retrospective analysis, Lancet Oncol, 20, 1065, 10.1016/S1470-2045(19)30338-9
Wilson, 2021, Fragility of randomized trials supporting cancer drug approvals stratified by approval pathway and review designations, Cancer Med, 10, 5405, 10.1002/cam4.4029
Desnoyers, 2021, Fragility index of trials supporting approval of anti-cancer drugs in common solid tumours, Cancer Treat Rev, 94, 10.1016/j.ctrv.2021.102167
Fan, 2020, China Kadoorie Biobank Collaborative Group. Frailty index and all-cause and cause-specific mortality in Chinese adults: a prospective cohort study, Lancet Public Health, 5, e650, 10.1016/S2468-2667(20)30113-4
Lulita, 2022, Association of alzheimer disease with life expectancy in people with down syndrome, JAMA Netw Open, 5
Vasudevan, 2021, Birth and death notification via mobile devices: a mixed methods systematic review, Cochrane Database Syst Rev, 7, CD012909
Allen-Graham, 2018, Electronic health records and online medical records: an asset or a liability under current conditions?, Aust Health Rev, 42, 59, 10.1071/AH16095
Okuyama, 2020, Impact of loss-to-follow-up on cancer survival estimates for small populations: a simulation study using Hospital-Based Cancer Registries in Japan, BMJ Open, 10, 10.1136/bmjopen-2019-033510
Skea, 2019, Exploring non-retention in clinical trials: a meta-ethnographic synthesis of studies reporting participant reasons for drop out, BMJ Open, 9, 10.1136/bmjopen-2018-021959
Templeton, 2020, Informative censoring - a neglected cause of bias in oncology trials, Nat Rev Clin Oncol, 17, 327, 10.1038/s41571-020-0368-0
Halpern, 2002, The continuing unethical conduct of underpowered clinical trials, JAMA, 288, 358, 10.1001/jama.288.3.358
McDermott, 2020, Preserving clinical trial integrity during the coronavirus pandemic, JAMA, 323, 2135, 10.1001/jama.2020.4689
Secemsky, 2022, Assessment of the social security administration death master file for comparative analysis studies of peripheral vascular devices, Value Health, S1098-3015, 1964
Rotteau, 2022, Striving for high reliability in healthcare: a qualitative study of the implementation of a hospital safety programme, BMJ Qual Saf, 10.1136/bmjqs-2021-013938
World Health Organization
Mikkelsen, 2015, A global assessment of civil registration and vital statistics systems: monitoring data quality and progress, Lancet, 386, 1395, 10.1016/S0140-6736(15)60171-4
Gensheimer, 2022, Accuracy of electronic medical record follow-up data for estimating the survival time of patients with cancer, JCO Clin Cancer Inform, 10.1200/CCI.22.00019
Bisrat, 2021, Implementation challenges and perception of care providers on electronic medical records at st. Paul's and Ayder Hospitals, Ethiopia, BMC Med Inform Decis Mak, 21, 306, 10.1186/s12911-021-01670-z
Lloyd, 2021, A National Survey of EMR Usability: comparisons between medical and nursing professions in the hospital and primary care sectors in Australia and Finland, Int J Med Inform, 154, 10.1016/j.ijmedinf.2021.104535
Mello, 2018, Clinical trial participants' views of the risks and benefits of data sharing, N Engl J Med, 378, 2202, 10.1056/NEJMsa1713258
Lupton, 2019, 'I'd like to think you could trust the government, but I don't really think we can': Australian women's attitudes to and experiences of My Health Record, Digit Health, 5
Nadav, 2021, How to implement digital services in a way that they integrate into routine work: qualitative interview study among health and social care professionals, J Med Internet Res, 23, 10.2196/31668
Chan, 2021, A "data sharing trust" model for rapid, collaborative science, Cell, 184, 566, 10.1016/j.cell.2021.01.006
Butler, 2008, Translational research: crossing the valley of death, Nature, 453, 840, 10.1038/453840a
Gillies, 2021, Strategies to improve retention in randomised trials, Cochrane Database Syst Rev, 3
Moslehpour, 2022, The effect of physician communication on inpatient satisfaction, Healthcare (Basel), 10, 463, 10.3390/healthcare10030463
Mowlabaccus, 2020, Participant perception, still a major challenge to clinical research in developing countries-A mixed methods study, PLoS One, 15, 10.1371/journal.pone.0236563
Schwarz, 2020, COVID-19 and the academy: it is time for going digital, Energy Res Soc Sci, 68, 10.1016/j.erss.2020.101684
Tay, 2021, Share methods through visual and digital protocols, Nature, 10.1038/d41586-021-02015-6