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10.1136/bmjopen-2015-007987 http://scihub22266oqcxt.onion/10.1136/bmjopen-2015-007987 C4458635!4458635 !26044760     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26044760 &cmd=llinks): Failed to open stream: HTTP request failed! 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Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012 |pdf=|usr=}}{{26044760 }} gab.com Text Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012 JO: BMJ Open http://www.kidney.de/pget.php?&tw=1&pmid=26044760 #FOAvip OBJECTIVES: Novel therapeutics are an important part of ophthalmologists' armamentarium, and the risks and benefits of these therapies must be carefully evaluated. We sought to quantify the characteristics of the pivotal clinical trials supporting the regulatory approval of new ophthalmic drugs and medical devices. DESIGN: Retrospective observational study. SETTING AND DATA SOURCE: Medical review dossiers for new ophthalmic drug and high-risk device approvals released publicly by the US Food and Drug Administration (FDA). MAIN OUTCOME MEASURES: Proportion of pivotal trials with randomisation, masking, active or placebo controls and subgroup analyses; total and median number of trial enrollees; and the number of drugs and devices approved with required postapproval studies. RESULTS: From 2002 to 2012, the FDA approved 11 ophthalmic drugs and 25 devices. The pivotal trials underlying the approvals of ophthalmic drugs in our study cohort enrolled a median of 809 patients. Virtually all drug trials were randomised and masked (91%), of which 7 (70%) used a placebo control. Pivotal trials for ophthalmic devices enrolled 324 patients on average, and significantly fewer trials for ophthalmic devices versus drugs were randomised (16% vs 91%; p<0.001) or masked (12% vs 91%; p<0.001). 8 (32%) ophthalmic devices and 6 (55%) ophthalmic drugs were approved with required postapproval studies. CONCLUSIONS: Ophthalmic therapeutics were approved based on varying levels of evidence. Postapproval studies could be used to confirm or refute early indications of safety and effectiveness of these therapeutics, with the study results accessible to patients and clinicians who need to make informed treatment decisions. Twit Text FOAVip Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012 ????BMJ Open http://www.kidney.de/pget.php?&tw=1&pmid=26044760 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26044760 #FOAvip English Wikipedia <ref>{{Cite pmid|26044760 }}</ref> Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012 #MMPMID26044760 Hwang J ; Hwang TJ ; Ciolino JB BMJ Open 2015[Jun]; 5 (6 ): e007987 PMID26044760 show ga OBJECTIVES: Novel therapeutics are an important part of ophthalmologists' armamentarium, and the risks and benefits of these therapies must be carefully evaluated. We sought to quantify the characteristics of the pivotal clinical trials supporting the regulatory approval of new ophthalmic drugs and medical devices. DESIGN: Retrospective observational study. SETTING AND DATA SOURCE: Medical review dossiers for new ophthalmic drug and high-risk device approvals released publicly by the US Food and Drug Administration (FDA). MAIN OUTCOME MEASURES: Proportion of pivotal trials with randomisation, masking, active or placebo controls and subgroup analyses; total and median number of trial enrollees; and the number of drugs and devices approved with required postapproval studies. RESULTS: From 2002 to 2012, the FDA approved 11 ophthalmic drugs and 25 devices. The pivotal trials underlying the approvals of ophthalmic drugs in our study cohort enrolled a median of 809 patients. Virtually all drug trials were randomised and masked (91%), of which 7 (70%) used a placebo control. Pivotal trials for ophthalmic devices enrolled 324 patients on average, and significantly fewer trials for ophthalmic devices versus drugs were randomised (16% vs 91%; p<0.001) or masked (12% vs 91%; p<0.001). 8 (32%) ophthalmic devices and 6 (55%) ophthalmic drugs were approved with required postapproval studies. CONCLUSIONS: Ophthalmic therapeutics were approved based on varying levels of evidence. Postapproval studies could be used to confirm or refute early indications of safety and effectiveness of these therapeutics, with the study results accessible to patients and clinicians who need to make informed treatment decisions. |*Drug Approval [MESH] |*Lenses, Intraocular [MESH] |*Pharmaceutical Preparations [MESH] |Administration, Ophthalmic [MESH] |Conjunctivitis, Bacterial/*drug therapy [MESH] |Decision Making [MESH] |Female [MESH] |Humans [MESH] |Macular Degeneration/*drug therapy [MESH] |Male [MESH] |Ophthalmic Solutions [MESH] |Randomized Controlled Trials as Topic [MESH] |Retrospective Studies [MESH] |United States [MESH]Pivotal clinical trials of novel ophthalmic drugs and medical devices:(epmc).pdf DeepDyve Pubget Overpricing