{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T23:30:02Z","timestamp":1792193402854,"version":"4.4.0"},"reference-count":66,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T00:00:00Z","timestamp":1687219200000},"content-version":"am","delay-in-days":323,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001146","name":"Greenwall Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001146","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000001","name":"National Science Foundation","doi-asserted-by":"publisher","award":["1945448"],"award-info":[{"award-number":["1945448"]}],"id":[{"id":"10.13039\/100000001","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["2 R01 AI108368-05"],"award-info":[{"award-number":["2 R01 AI108368-05"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2022,8]]},"DOI":"10.1016\/j.cct.2022.106806","type":"journal-article","created":{"date-parts":[[2022,5,30]],"date-time":"2022-05-30T20:37:05Z","timestamp":1653943025000},"page":"106806","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":40,"special_numbering":"C","title":["Clinical trials in pregnancy and the \u201cshadows of thalidomide\u201d: Revisiting the legacy of Frances Kelsey"],"prefix":"10.1016","volume":"119","author":[{"given":"Miranda R.","family":"Waggoner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Drapkin","family":"Lyerly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cct.2022.106806_bb0005","series-title":"Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry \u2013 Draft Guidance","author":"FDA (U.S. Food and Drug Administration)","year":"2018"},{"key":"10.1016\/j.cct.2022.106806_bb0010","series-title":"Public Meeting, Robert J. Margolis Center for Health Policy at Duke University, in Cooperation with the U.S. Food and Drug Administration (FDA)","article-title":"Scientific and ethical considerations for the inclusion of pregnant women in clinical trials","year":"2021"},{"key":"10.1016\/j.cct.2022.106806_bb0015","series-title":"Task Force on Research Specific to Pregnant Women and Lactating Women","author":"PRGLAC","year":"2018"},{"key":"10.1016\/j.cct.2022.106806_bb0020","author":"PHASES (The PHASES Working Group)"},{"key":"10.1016\/j.cct.2022.106806_bb0025","doi-asserted-by":"crossref","DOI":"10.1016\/j.cct.2021.106515","article-title":"Eligibility criteria and clinical trials: an FDA perspective","volume":"109","author":"Duggal","year":"2021","journal-title":"Contemporary Clin. Trials"},{"issue":"4","key":"10.1016\/j.cct.2022.106806_bb0030","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1001\/jama.2017.19138","article-title":"Improving public health requires inclusion of underrepresented populations in research","volume":"319","author":"Spong","year":"2018","journal-title":"JAMA"},{"issue":"2","key":"10.1016\/j.cct.2022.106806_bb0035","doi-asserted-by":"crossref","first-page":"5","DOI":"10.3138\/ijfab.1.2.5","article-title":"The second wave: toward responsible inclusion of pregnant women in research","volume":"1","author":"Lyerly","year":"2008","journal-title":"Int. J. Feminist Approaches Bioethics"},{"key":"10.1016\/j.cct.2022.106806_bb0040","series-title":"Clinical Research Involving Pregnant Women","first-page":"33","article-title":"Better safe than sorry: risk, stigma, and research during pregnancy","author":"Langston","year":"2016"},{"issue":"5","key":"10.1016\/j.cct.2022.106806_bb0045","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1016\/j.ajog.2021.01.025","article-title":"Balancing risks: making decisions for maternal treatment without data on fetal safety","volume":"224","author":"Minkoff","year":"2021","journal-title":"Am. J. Obstet. Gynecol."},{"key":"10.1016\/j.cct.2022.106806_bb0050","series-title":"Dark Remedy: The Impact of Thalidomide and its Revival as a Vital Medicine","author":"Brynner","year":"2001"},{"key":"10.1016\/j.cct.2022.106806_bb0055","series-title":"Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA","author":"Carpenter","year":"2010"},{"issue":"16","key":"10.1016\/j.cct.2022.106806_bb0060","doi-asserted-by":"crossref","first-page":"1481","DOI":"10.1056\/NEJMp1210007","article-title":"Reform, regulation, and pharmaceuticals\u2014the Kefauver-Harris Amendments at 50","volume":"367","author":"Greene","year":"2012","journal-title":"N. Engl. J. Med."},{"issue":"19","key":"10.1016\/j.cct.2022.106806_bb0065","first-page":"2109","article-title":"Frances Kelsey honored for FDA legacy: award notes her work on thalidomide","volume":"304","author":"Kuehn","year":"2010","journal-title":"Clin. Trials. JAMA"},{"key":"10.1016\/j.cct.2022.106806_bb0070","series-title":"In 2015 Obituaries, Distant Eras Were Evoked","author":"McDonald","year":"2015"},{"key":"10.1016\/j.cct.2022.106806_bb0075","series-title":"America Desperately Needs a Much Better F.D.A","author":"Manjoo","year":"2021"},{"key":"10.1016\/j.cct.2022.106806_bb0080","series-title":"The F.D.A. Has Reached a New Low","author":"Kesselheim","year":"2021"},{"issue":"1","key":"10.1016\/j.cct.2022.106806_bb0085","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.ajog.2021.02.032","article-title":"Prescription medications for use in pregnancy\u2014perspective from the US Food and Drug Administration","volume":"225","author":"Wesley","year":"2021","journal-title":"Am. J. Obstet. Gynecol."},{"key":"10.1016\/j.cct.2022.106806_bb0090","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1002\/ajmg.c.30313","article-title":"Evolving knowledge of the teratogenicity of medication in human pregnancy","volume":"157","author":"Adam","year":"2011","journal-title":"Am. J. Med. Genet. C: Semin. Med. Genet."},{"issue":"8","key":"10.1016\/j.cct.2022.106806_bb0095","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2020.15094","article-title":"Evaluation of drug labels following the 2015 pregnancy and lactation labeling rule","volume":"3","author":"Byrne","year":"2020","journal-title":"JAMA Netw. Open"},{"issue":"11","key":"10.1016\/j.cct.2022.106806_bb0100","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002160","article-title":"Pregnancy-associated changes in pharmacokinetics: a systematic review","volume":"13","author":"Pariente","year":"2016","journal-title":"PLoS Med."},{"key":"10.1016\/j.cct.2022.106806_bb0105","series-title":"Frances Oldham Kelsey Papers, Manuscript Division, Library of Congress, Washington, D.C. Box I:4, Folder 10","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0110","series-title":"Chemical Teratogens. Presentation for the Annual Health Conference, New York City, June 11, 1963. Frances Oldham Kelsey Papers, Manuscript Division, Library of Congress, Washington, D.C. Box I:4, Folder 12","author":"Kelsey","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0115","author":"Kelsey","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0120","series-title":"Drugs and the Fetus. Presentation for The Children\u2019s Hospital Medical Center, Boston, November 26, 1968. Frances Oldham Kelsey Papers, Manuscript Division, Library of Congress, Washington, D.C. Box I:5, Folder 3","author":"Kelsey","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0125","series-title":"Drugs and Pregnancy. Presentation for the American Association on Mental Deficiency, Boston, May 1, 1968. Frances Oldham Kelsey Papers, Manuscript Division, Library of Congress, Washington, D.C. Box I:5, Folder 3","author":"Kelsey","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0130","author":"Kelsey","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0135","author":"Kelsey","year":"2022"},{"issue":"5","key":"10.1016\/j.cct.2022.106806_bb0140","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1177\/0193841X9001400502","article-title":"Women and HIV\/AIDS research: the barriers to equity","volume":"14","author":"Levine","year":"1990","journal-title":"Eval. Rev."},{"key":"10.1016\/j.cct.2022.106806_bb0145","series-title":"Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1","year":"1994"},{"issue":"154","key":"10.1016\/j.cct.2022.106806_bb0150","first-page":"33525","article-title":"Protection of human subjects: fetuses, pregnant women, and in vitro fertilization","volume":"40","author":"DHEW (Department of Health, Education, and Welfare)","year":"1975","journal-title":"Fed. Regist."},{"key":"10.1016\/j.cct.2022.106806_bb0155","series-title":"General Considerations for the Clinical Evaluation of Drugs. HEW Publication No. (FDA) 77\u20133040","author":"FDA (U.S. Food and Drug Administration)","year":"1977"},{"issue":"9","key":"10.1016\/j.cct.2022.106806_bb0160","doi-asserted-by":"crossref","first-page":"703","DOI":"10.1097\/00001888-199409000-00004","article-title":"Historical background of changes in FDA policy on the study and evaluation of drugs in women","volume":"69","author":"Merkatz","year":"1994","journal-title":"Acad. Med."},{"key":"10.1016\/j.cct.2022.106806_bb0165","doi-asserted-by":"crossref","DOI":"10.1007\/s11017-022-09578-z","article-title":"\u2018Experimental pregnancy\u2019 revisited","author":"Lyerly","year":"2022","journal-title":"Theoretical Med. Bioethics"},{"key":"10.1016\/j.cct.2022.106806_bb0170","series-title":"Feminism & Bioethics: Beyond Reproduction","first-page":"216","article-title":"Ethical obstacles to the participation of women in biomedical research","author":"Merton","year":"1996"},{"key":"10.1016\/j.cct.2022.106806_bb0175","series-title":"Impure Science: AIDS, Activism, and the Politics of Knowledge","author":"Epstein","year":"1996"},{"key":"10.1016\/j.cct.2022.106806_bb0180","series-title":"Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2","first-page":"1","article-title":"Women\u2019s participation in clinical research: from protectionism to access","author":"Johnson","year":"1994"},{"issue":"139","key":"10.1016\/j.cct.2022.106806_bb0185","first-page":"39406","article-title":"Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice","volume":"58","author":"FDA (U.S. Food and Drug Administration)","year":"1993","journal-title":"Fed. Regist."},{"key":"10.1016\/j.cct.2022.106806_bb0190","series-title":"Women\u2019s Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement. GAO-01-754","author":"GAO (U.S. General Accounting Office)","year":"2001"},{"key":"10.1016\/j.cct.2022.106806_bb0195","series-title":"Inclusion: The Politics of Difference in Medical Research","author":"Epstein","year":"2007"},{"issue":"4","key":"10.1016\/j.cct.2022.106806_bb0200","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1056\/NEJM199307223290429","article-title":"Women in clinical trials of new drugs: a change in Food and Drug Administration policy","volume":"329","author":"Merkatz","year":"1993","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2022.106806_bb0205","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1111\/j.1552-6909.1998.tb02594.x","article-title":"Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues","volume":"27","author":"Merkatz","year":"1998","journal-title":"JOGNN"},{"issue":"24","key":"10.1016\/j.cct.2022.106806_bb0210","doi-asserted-by":"crossref","first-page":"2241","DOI":"10.1056\/NEJMp1003462","article-title":"Enrolling pregnant women in research \u2014 lessons from the H1N1 influenza pandemic","volume":"362","author":"Goldkind","year":"2010","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2022.106806_bb0215","series-title":"Dangerous Pregnancies: Mothers, Disabilities, and Abortion in Modern America","author":"Reagan","year":"2010"},{"issue":"6","key":"10.1016\/j.cct.2022.106806_bb0220","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1353\/hcr.0.0211","article-title":"Risk and the pregnant body","volume":"39","author":"Lyerly","year":"2009","journal-title":"Hast. Cent. Rep."},{"issue":"9","key":"10.1016\/j.cct.2022.106806_bb0225","doi-asserted-by":"crossref","first-page":"695","DOI":"10.1097\/00001888-199409000-00002","article-title":"Historical background of clinical trials involving women and minorities","volume":"69","author":"McCarthy","year":"1994","journal-title":"Acad. Med."},{"key":"10.1016\/j.cct.2022.106806_bb0230","series-title":"Feminism and Bioethics: Beyond Reproduction","first-page":"252","article-title":"Women as vessels and vectors: Lessons from the HIV epidemic","author":"Faden","year":"1996"},{"key":"10.1016\/j.cct.2022.106806_bb0235","series-title":"Emerging Issues in Biomedical Policy","article-title":"Women as research subjects: New priorities, new questions","volume":"Vol. 2","author":"Levine","year":"1993"},{"key":"10.1016\/j.cct.2022.106806_bb0240","series-title":"Pregnant Women Can Finally Expect Better. Hastings Center Report (January\u2013February)","first-page":"10","author":"Ballantyne","year":"2019"},{"issue":"Suppl. 3","key":"10.1016\/j.cct.2022.106806_bb0245","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1186\/s12978-017-0419-x","article-title":"Research with pregnant women: a call to action","volume":"14","author":"Little","year":"2017","journal-title":"Reprod. Health"},{"issue":"44","key":"10.1016\/j.cct.2022.106806_bb0250","doi-asserted-by":"crossref","first-page":"6922","DOI":"10.1016\/j.vaccine.2020.08.059","article-title":"Pregnant women\u2019s perceptions of risks and benefits when considering participation in vaccine trials","volume":"38","author":"Jaffe","year":"2020","journal-title":"Vaccine"},{"issue":"4","key":"10.1016\/j.cct.2022.106806_bb0255","first-page":"1","article-title":"Women\u2019s views about participating in research while pregnant","volume":"34","author":"Lyerly","year":"2012","journal-title":"IRB: Ethics Human Res."},{"issue":"9","key":"10.1016\/j.cct.2022.106806_bb0260","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1001\/jamapsychiatry.2016.1538","article-title":"Use of antipsychotics during pregnancy: pregnant women get sick\u2014sick women get pregnant","volume":"73","author":"Wisner","year":"2016","journal-title":"JAMA Psychiatry"},{"issue":"5","key":"10.1016\/j.cct.2022.106806_bb0265","doi-asserted-by":"crossref","first-page":"1077","DOI":"10.1097\/AOG.0b013e3182a9ca67","article-title":"Exclusion of pregnant women from industry-sponsored clinical trials","volume":"122","author":"Shields","year":"2013","journal-title":"Obstet. Gynecol."},{"issue":"Suppl. 3","key":"10.1016\/j.cct.2022.106806_bb0270","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1186\/s12978-017-0430-2","article-title":"Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials","volume":"14","author":"Gomes","year":"2017","journal-title":"Reprod. Health"},{"key":"10.1016\/j.cct.2022.106806_bb0275","series-title":"Constructing Grounded Theory","author":"Charmaz","year":"2014"},{"key":"10.1016\/j.cct.2022.106806_bb0280","series-title":"Thalidomide Opponent Named to Head New U.S. Drugs Unit","author":"Special to The New York Times","year":"1962"},{"key":"10.1016\/j.cct.2022.106806_bb0285","series-title":"Thalidomide: The American Experience","author":"Geng","year":"1973"},{"key":"10.1016\/j.cct.2022.106806_bb0290","series-title":"Frances Oldham Kelsey, Who Saved U.S. Babies From Thalidomide, Dies at 101","author":"McFadden","year":"2015"},{"key":"10.1016\/j.cct.2022.106806_bb0295","author":"Kelsey","year":"2022"},{"key":"10.1016\/j.cct.2022.106806_bb0300","series-title":"Postapproval Pregnancy Safety Studies Guidance for Industry \u2013 Draft Guidance","author":"FDA (U.S. Food and Drug Administration)","year":"2019"},{"key":"10.1016\/j.cct.2022.106806_bb0305","series-title":"The Public\u2019s Quiet Savior From Harmful Medicines","author":"Harris","year":"2010"},{"key":"10.1016\/j.cct.2022.106806_bb0310","series-title":"The Unseen Survivors of Thalidomide Want to Be Heard","author":"Thomas","year":"2020"},{"key":"10.1016\/j.cct.2022.106806_bb0315","series-title":"A Shot in the Arm for the F.D.A","author":"Burkholz","year":"1991"},{"key":"10.1016\/j.cct.2022.106806_bb0320","series-title":"37 Years Later, a Second Chance for Thalidomide","author":"Stolberg","year":"1997"},{"key":"10.1016\/j.cct.2022.106806_bb0325","series-title":"Drugs, Greed and a Dead Boy","author":"Kristof","year":"2015"},{"key":"10.1016\/j.cct.2022.106806_bb0330","author":"Kweder"}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442200132X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442200132X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T08:55:44Z","timestamp":1761555344000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S155171442200132X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8]]},"references-count":66,"alternative-id":["S155171442200132X"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2022.106806","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2022,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Clinical trials in pregnancy and the \u201cshadows of thalidomide\u201d: Revisiting the legacy of Frances Kelsey","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2022.106806","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"106806"}}