{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T20:55:11Z","timestamp":1714683311645},"reference-count":0,"publisher":"SAGE Publications","issue":"7","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Investig Med"],"published-print":{"date-parts":[[2004,11,1]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The need for phase I and II clinical trials to have a data and safety monitoring plan (DSMP) is widely accepted; however, whether and\/or when these trials should also have oversight by a data and safety monitoring board (DSMB) is controversial. Monitoring requirements also depend on whether the study is funded by the National Institutes of Health, funded and\/or monitored by the US Food and Drug Administration (FDA), or funded by industry. However, there is little guidance about when and how to constitute a DSMB for phase I and II clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The objectives of this article are to suggest guidelines for when and how to constitute a DSMB for phase I and II studies and to highlight the similarities and differences between DSMBs monitoring phase I and II versus phase III clinical studies. We highlight the utility of these guidelines in the safety monitoring of a mechanism of disease-based study of inhaled nitric oxide for acute vaso-occlusive crisis in pediatric patients with sickle cell disease that was funded and regulated by the FDA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The goal of DSMPs regardless of the phase of the clinical trial is to protect participant safety and ensure the integrity and validity of the data. A DSMB can ensure that risks and data are evaluated in a timely, efficient, and unbiased manner. We describe \u201crisk-based\u201d guidelines to determine situations in which a DSMB may be an appropriate addition to a DSMP for phase I and II clinical trials. We also address the roles and responsibilities of the DSMB for these studies.<\/jats:p><\/jats:sec>","DOI":"10.1136\/jim-52-07-36","type":"journal-article","created":{"date-parts":[[2016,5,10]],"date-time":"2016-05-10T23:43:02Z","timestamp":1462923782000},"page":"446-452","update-policy":"http:\/\/dx.doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Monitoring Participant Safety in Phase I and II Interventional Trials: Options and Controversies"],"prefix":"10.1177","volume":"52","author":[{"given":"Patricia L.","family":"Hibberd","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debra L.","family":"Weiner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,1,4]]},"container-title":["Journal of Investigative Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jim-52-07-36","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,4]],"date-time":"2023-01-04T12:39:11Z","timestamp":1672835951000},"score":1,"resource":{"primary":{"URL":"http:\/\/jim.bmj.com\/lookup\/doi\/10.1136\/jim-52-07-36"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2004,11,1]]},"references-count":0,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2016,1,4]]},"published-print":{"date-parts":[[2004,11,1]]}},"alternative-id":["10.1136\/jim-52-07-36"],"URL":"https:\/\/doi.org\/10.1136\/jim-52-07-36","relation":{},"ISSN":["1081-5589","1708-8267"],"issn-type":[{"value":"1081-5589","type":"print"},{"value":"1708-8267","type":"electronic"}],"subject":[],"published":{"date-parts":[[2004,11,1]]}}}