Publication Practices Among Pivotal Clinical Trials of High-Risk Medical Devices
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Publisher
Springer Nature Switzerland
Link
https://link.springer.com/content/pdf/10.1007/978-3-031-42782-4_1
Reference8 articles.
1. Chang, L., Dhruva, S.S., Chu, J., et al.: Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports. BMJ 350, h2613 (2015). https://doi.org/10.1136/bmj.h2613
2. Rising, K., Bacchetti, P., Bero, L.: Reporting bias in drug trials submitted to the food and drug administration: review of publication and presentation. PLoS Med. 5, e217 (2008). https://doi.org/10.1371/journal.pmed.0050217
3. Zimmerman, K.O., Smith, P.B., McMahon, A.W., et al.: Duration of pediatric clinical trials submitted to the US food and drug administration. JAMA Pediatr. 173, 60–67 (2019). https://doi.org/10.1001/jamapediatrics.2018.3227
4. Swanson, M.J., Johnston, J.L., Ross, J.S.: Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA. Trials 22, 817 (2021). https://doi.org/10.1186/s13063-021-05790-9
5. Smithy, J.W., Downing, N.S., Ross, J.S.: Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study. JAMA Intern. Med. 174, 1518–1520 (2014). https://doi.org/10.1001/jamainternmed.2014.3438
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