Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine
IMPORTANCE: Off-label treatment was common for ophthalmia neonatorum because only erythromycin ointment had been approved by the US Food and Drug Administration (FDA) for this indication. Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older ch...
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| Veröffentlicht in: | Archives of ophthalmology (1960) 2021-02, Vol.139 (2), p.214-217 |
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| creator | Sun, Haihao Temeck, Jean W McCune, Susan K Chambers, Wiley A |
| description | IMPORTANCE: Off-label treatment was common for ophthalmia neonatorum because only erythromycin ointment had been approved by the US Food and Drug Administration (FDA) for this indication. Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older children and adults because of uncertain similarities in the cause of disease and the treatment course between the 2 populations. Prospective therapeutic clinical studies were required to demonstrate the effectiveness of treatment for ophthalmia neonatorum. OBJECTIVE: To review the therapeutic clinical trials for patients with bacterial conjunctivitis to evaluate the similarity in the cause of disease and the treatment response between neonates and older children and adults. DESIGN, SETTING, AND PARTICIPANTS: In this comparative effectiveness research review of pooled data from the most recent 30 bacterial conjunctivitis trials (N = 2018) submitted to the FDA to support the approval of topical ophthalmic solutions for older children and adults, 95% CIs were constructed from clinical cure rates. Cure rates in 3 neonatal randomized clinical trials (N = 392) of patients treated with ophthalmic anti-infective solutions of ciprofloxacin, gatifloxacin, and moxifloxacin were constructed and compared. The baseline ocular swab cultures were analyzed. MAIN OUTCOMES AND MEASURES: Cure rates of neonatal trials were compared with the 95% CIs among older children and adults. The bacterial organisms isolated from these 2 populations were compared. RESULTS: The 3 neonatal trials enrolled a total of 392 patients, and the 30 trials of older children and adults enrolled a total of 2018 patients. Neonatal clinical cure rates for moxifloxacin (day 4, 48%), ciprofloxacin (day 4, 49%; day 5, 61%), and gatifloxacin (day 7, 79%) were within the 95% CI for products approved to treat older children and adults with bacterial conjunctivitis. Bacterial organisms were consistent between these 2 populations. CONCLUSIONS AND RELEVANCE: Comparison of the pooled analysis of these historical trial data suggests similarity in the cause of disease and the treatment response between neonates and older children and adults with bacterial conjunctivitis. Therefore, it was appropriate to extrapolate the effectiveness from older children and adults to neonates to support the approval of therapies for ophthalmia neonatorum. Based on this analysis, ophthalmic solutions of ciprofloxacin, gatifloxacin, and moxi |
| doi_str_mv | 10.1001/jamaophthalmol.2020.5558 |
| format | Article |
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Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older children and adults because of uncertain similarities in the cause of disease and the treatment course between the 2 populations. Prospective therapeutic clinical studies were required to demonstrate the effectiveness of treatment for ophthalmia neonatorum. OBJECTIVE: To review the therapeutic clinical trials for patients with bacterial conjunctivitis to evaluate the similarity in the cause of disease and the treatment response between neonates and older children and adults. DESIGN, SETTING, AND PARTICIPANTS: In this comparative effectiveness research review of pooled data from the most recent 30 bacterial conjunctivitis trials (N = 2018) submitted to the FDA to support the approval of topical ophthalmic solutions for older children and adults, 95% CIs were constructed from clinical cure rates. Cure rates in 3 neonatal randomized clinical trials (N = 392) of patients treated with ophthalmic anti-infective solutions of ciprofloxacin, gatifloxacin, and moxifloxacin were constructed and compared. The baseline ocular swab cultures were analyzed. MAIN OUTCOMES AND MEASURES: Cure rates of neonatal trials were compared with the 95% CIs among older children and adults. The bacterial organisms isolated from these 2 populations were compared. RESULTS: The 3 neonatal trials enrolled a total of 392 patients, and the 30 trials of older children and adults enrolled a total of 2018 patients. Neonatal clinical cure rates for moxifloxacin (day 4, 48%), ciprofloxacin (day 4, 49%; day 5, 61%), and gatifloxacin (day 7, 79%) were within the 95% CI for products approved to treat older children and adults with bacterial conjunctivitis. Bacterial organisms were consistent between these 2 populations. CONCLUSIONS AND RELEVANCE: Comparison of the pooled analysis of these historical trial data suggests similarity in the cause of disease and the treatment response between neonates and older children and adults with bacterial conjunctivitis. Therefore, it was appropriate to extrapolate the effectiveness from older children and adults to neonates to support the approval of therapies for ophthalmia neonatorum. Based on this analysis, ophthalmic solutions of ciprofloxacin, gatifloxacin, and moxifloxacin are now approved for all age groups. This analysis presents an approach of using pooled data from previously underpowered individual trials to establish the similarities in the cause of disease and in treatment response between children and adults, which are the fundamental elements used to evaluate whether extrapolation of effectiveness can be used to support drug approval.</description><identifier>ISSN: 2168-6165</identifier><identifier>EISSN: 2168-6173</identifier><identifier>DOI: 10.1001/jamaophthalmol.2020.5558</identifier><identifier>PMID: 33331874</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Administration, Ophthalmic ; Age Factors ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - adverse effects ; Bacteria ; Brief Report ; Children ; Ciprofloxacin ; Clinical trials ; Comments ; Comparative Effectiveness Research ; Conjunctivitis ; Conjunctivitis, Bacterial - diagnosis ; Conjunctivitis, Bacterial - drug therapy ; Conjunctivitis, Bacterial - microbiology ; Drug Approval ; Erythromycin ; Evidence-Based Medicine ; FDA approval ; Gatifloxacin ; Humans ; Infant, Newborn ; Medical treatment ; Moxifloxacin ; Neonates ; Online First ; Ophthalmia ; Ophthalmia Neonatorum - diagnosis ; Ophthalmia Neonatorum - drug therapy ; Ophthalmia Neonatorum - microbiology ; Ophthalmic Solutions ; Patients ; Population studies ; Randomized Controlled Trials as Topic ; Remission Induction ; Treatment Outcome ; United States ; United States Food and Drug Administration</subject><ispartof>Archives of ophthalmology (1960), 2021-02, Vol.139 (2), p.214-217</ispartof><rights>Copyright American Medical Association Feb 2021</rights><rights>Copyright 2020 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a362t-129f0a6ebc78469f6b80c954d8d2a8a0dd696cfec43e38530593ab1fdba3269b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jamaophthalmology/articlepdf/10.1001/jamaophthalmol.2020.5558$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/jamaophthalmol.2020.5558$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76232,76235</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33331874$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sun, Haihao</creatorcontrib><creatorcontrib>Temeck, Jean W</creatorcontrib><creatorcontrib>McCune, Susan K</creatorcontrib><creatorcontrib>Chambers, Wiley A</creatorcontrib><title>Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine</title><title>Archives of ophthalmology (1960)</title><addtitle>JAMA Ophthalmol</addtitle><description>IMPORTANCE: Off-label treatment was common for ophthalmia neonatorum because only erythromycin ointment had been approved by the US Food and Drug Administration (FDA) for this indication. Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older children and adults because of uncertain similarities in the cause of disease and the treatment course between the 2 populations. Prospective therapeutic clinical studies were required to demonstrate the effectiveness of treatment for ophthalmia neonatorum. OBJECTIVE: To review the therapeutic clinical trials for patients with bacterial conjunctivitis to evaluate the similarity in the cause of disease and the treatment response between neonates and older children and adults. DESIGN, SETTING, AND PARTICIPANTS: In this comparative effectiveness research review of pooled data from the most recent 30 bacterial conjunctivitis trials (N = 2018) submitted to the FDA to support the approval of topical ophthalmic solutions for older children and adults, 95% CIs were constructed from clinical cure rates. Cure rates in 3 neonatal randomized clinical trials (N = 392) of patients treated with ophthalmic anti-infective solutions of ciprofloxacin, gatifloxacin, and moxifloxacin were constructed and compared. The baseline ocular swab cultures were analyzed. MAIN OUTCOMES AND MEASURES: Cure rates of neonatal trials were compared with the 95% CIs among older children and adults. The bacterial organisms isolated from these 2 populations were compared. RESULTS: The 3 neonatal trials enrolled a total of 392 patients, and the 30 trials of older children and adults enrolled a total of 2018 patients. Neonatal clinical cure rates for moxifloxacin (day 4, 48%), ciprofloxacin (day 4, 49%; day 5, 61%), and gatifloxacin (day 7, 79%) were within the 95% CI for products approved to treat older children and adults with bacterial conjunctivitis. Bacterial organisms were consistent between these 2 populations. CONCLUSIONS AND RELEVANCE: Comparison of the pooled analysis of these historical trial data suggests similarity in the cause of disease and the treatment response between neonates and older children and adults with bacterial conjunctivitis. Therefore, it was appropriate to extrapolate the effectiveness from older children and adults to neonates to support the approval of therapies for ophthalmia neonatorum. Based on this analysis, ophthalmic solutions of ciprofloxacin, gatifloxacin, and moxifloxacin are now approved for all age groups. This analysis presents an approach of using pooled data from previously underpowered individual trials to establish the similarities in the cause of disease and in treatment response between children and adults, which are the fundamental elements used to evaluate whether extrapolation of effectiveness can be used to support drug approval.</description><subject>Administration, Ophthalmic</subject><subject>Age Factors</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Bacteria</subject><subject>Brief Report</subject><subject>Children</subject><subject>Ciprofloxacin</subject><subject>Clinical trials</subject><subject>Comments</subject><subject>Comparative Effectiveness Research</subject><subject>Conjunctivitis</subject><subject>Conjunctivitis, Bacterial - diagnosis</subject><subject>Conjunctivitis, Bacterial - drug therapy</subject><subject>Conjunctivitis, Bacterial - microbiology</subject><subject>Drug Approval</subject><subject>Erythromycin</subject><subject>Evidence-Based Medicine</subject><subject>FDA approval</subject><subject>Gatifloxacin</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Medical treatment</subject><subject>Moxifloxacin</subject><subject>Neonates</subject><subject>Online First</subject><subject>Ophthalmia</subject><subject>Ophthalmia Neonatorum - diagnosis</subject><subject>Ophthalmia Neonatorum - drug therapy</subject><subject>Ophthalmia Neonatorum - microbiology</subject><subject>Ophthalmic Solutions</subject><subject>Patients</subject><subject>Population studies</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Remission Induction</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>2168-6165</issn><issn>2168-6173</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUctu1DAUtRCIVkN_gAWyxDqDH4njsEAqbWkrFYpEu7ZubGfGoyQOtjMVf8Bn16MZRvRubOk87tE9CGFKlpQQ-mkDA_hpndbQD75fMsLIsqoq-QqdMipkIWjNXx__ojpBZzFuSB5JSMmrt-iE56GyLk_R38foxhW-cTH54DT0-BIS4OTxr3mafEj4fJqC32bAd_gyzCv8M3gz6xRx5wO-PwRxgH9YP0J2mYfP-HYcsya5rd3rQa_xg3-CYPDV1hk7alt8hWgN_m6N026079CbDvpozw7vAj1-u3q4uCnu7q9vL87vCuCCpYKypiMgbKtrWYqmE60kuqlKIw0DCcQY0QjdWV1yy2XFSdVwaGlnWuBMNC1foC9732luB2u0HVOAXk3BDRD-KA9OvURGt1Yrv1V1XdYk322BPh4Mgv8925jUxs9hzJkVK5s6n10QkVlyz9LBxxhsd9xAidrVqF7WqHY1ql2NWfrh_4RH4b_SMuH9npAdjijL-VjF-DOAiqll</recordid><startdate>20210201</startdate><enddate>20210201</enddate><creator>Sun, Haihao</creator><creator>Temeck, Jean W</creator><creator>McCune, Susan K</creator><creator>Chambers, Wiley A</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>5PM</scope></search><sort><creationdate>20210201</creationdate><title>Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine</title><author>Sun, Haihao ; Temeck, Jean W ; McCune, Susan K ; Chambers, Wiley A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a362t-129f0a6ebc78469f6b80c954d8d2a8a0dd696cfec43e38530593ab1fdba3269b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Administration, Ophthalmic</topic><topic>Age Factors</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Anti-Bacterial Agents - adverse effects</topic><topic>Bacteria</topic><topic>Brief Report</topic><topic>Children</topic><topic>Ciprofloxacin</topic><topic>Clinical trials</topic><topic>Comments</topic><topic>Comparative Effectiveness Research</topic><topic>Conjunctivitis</topic><topic>Conjunctivitis, Bacterial - diagnosis</topic><topic>Conjunctivitis, Bacterial - drug therapy</topic><topic>Conjunctivitis, Bacterial - microbiology</topic><topic>Drug Approval</topic><topic>Erythromycin</topic><topic>Evidence-Based Medicine</topic><topic>FDA approval</topic><topic>Gatifloxacin</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Medical treatment</topic><topic>Moxifloxacin</topic><topic>Neonates</topic><topic>Online First</topic><topic>Ophthalmia</topic><topic>Ophthalmia Neonatorum - diagnosis</topic><topic>Ophthalmia Neonatorum - drug therapy</topic><topic>Ophthalmia Neonatorum - microbiology</topic><topic>Ophthalmic Solutions</topic><topic>Patients</topic><topic>Population studies</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Remission Induction</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>United States Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sun, Haihao</creatorcontrib><creatorcontrib>Temeck, Jean W</creatorcontrib><creatorcontrib>McCune, Susan K</creatorcontrib><creatorcontrib>Chambers, Wiley A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Archives of ophthalmology (1960)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sun, Haihao</au><au>Temeck, Jean W</au><au>McCune, Susan K</au><au>Chambers, Wiley A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine</atitle><jtitle>Archives of ophthalmology (1960)</jtitle><addtitle>JAMA Ophthalmol</addtitle><date>2021-02-01</date><risdate>2021</risdate><volume>139</volume><issue>2</issue><spage>214</spage><epage>217</epage><pages>214-217</pages><issn>2168-6165</issn><eissn>2168-6173</eissn><abstract>IMPORTANCE: Off-label treatment was common for ophthalmia neonatorum because only erythromycin ointment had been approved by the US Food and Drug Administration (FDA) for this indication. Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older children and adults because of uncertain similarities in the cause of disease and the treatment course between the 2 populations. Prospective therapeutic clinical studies were required to demonstrate the effectiveness of treatment for ophthalmia neonatorum. OBJECTIVE: To review the therapeutic clinical trials for patients with bacterial conjunctivitis to evaluate the similarity in the cause of disease and the treatment response between neonates and older children and adults. DESIGN, SETTING, AND PARTICIPANTS: In this comparative effectiveness research review of pooled data from the most recent 30 bacterial conjunctivitis trials (N = 2018) submitted to the FDA to support the approval of topical ophthalmic solutions for older children and adults, 95% CIs were constructed from clinical cure rates. Cure rates in 3 neonatal randomized clinical trials (N = 392) of patients treated with ophthalmic anti-infective solutions of ciprofloxacin, gatifloxacin, and moxifloxacin were constructed and compared. The baseline ocular swab cultures were analyzed. MAIN OUTCOMES AND MEASURES: Cure rates of neonatal trials were compared with the 95% CIs among older children and adults. The bacterial organisms isolated from these 2 populations were compared. RESULTS: The 3 neonatal trials enrolled a total of 392 patients, and the 30 trials of older children and adults enrolled a total of 2018 patients. Neonatal clinical cure rates for moxifloxacin (day 4, 48%), ciprofloxacin (day 4, 49%; day 5, 61%), and gatifloxacin (day 7, 79%) were within the 95% CI for products approved to treat older children and adults with bacterial conjunctivitis. Bacterial organisms were consistent between these 2 populations. CONCLUSIONS AND RELEVANCE: Comparison of the pooled analysis of these historical trial data suggests similarity in the cause of disease and the treatment response between neonates and older children and adults with bacterial conjunctivitis. Therefore, it was appropriate to extrapolate the effectiveness from older children and adults to neonates to support the approval of therapies for ophthalmia neonatorum. Based on this analysis, ophthalmic solutions of ciprofloxacin, gatifloxacin, and moxifloxacin are now approved for all age groups. This analysis presents an approach of using pooled data from previously underpowered individual trials to establish the similarities in the cause of disease and in treatment response between children and adults, which are the fundamental elements used to evaluate whether extrapolation of effectiveness can be used to support drug approval.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>33331874</pmid><doi>10.1001/jamaophthalmol.2020.5558</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Archives of ophthalmology (1960), 2021-02, Vol.139 (2), p.214-217 |
| issn | 2168-6165 2168-6173 |
| language | eng |
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| subjects | Administration, Ophthalmic Age Factors Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Bacteria Brief Report Children Ciprofloxacin Clinical trials Comments Comparative Effectiveness Research Conjunctivitis Conjunctivitis, Bacterial - diagnosis Conjunctivitis, Bacterial - drug therapy Conjunctivitis, Bacterial - microbiology Drug Approval Erythromycin Evidence-Based Medicine FDA approval Gatifloxacin Humans Infant, Newborn Medical treatment Moxifloxacin Neonates Online First Ophthalmia Ophthalmia Neonatorum - diagnosis Ophthalmia Neonatorum - drug therapy Ophthalmia Neonatorum - microbiology Ophthalmic Solutions Patients Population studies Randomized Controlled Trials as Topic Remission Induction Treatment Outcome United States United States Food and Drug Administration |
| title | Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine |
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