{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T15:43:36Z","timestamp":1782315816829,"version":"3.54.5"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T00:00:00Z","timestamp":1734998400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2025,4]]},"abstract":"Real\u2010world data (RWD) collected to generate real\u2010world evidence (RWE) holds promise for expediting patient and healthcare provider access to new in\u00a0vitro diagnostics (IVDs) by serving as evidence to demonstrate test performance or utility. However, uncertainties remain for IVD developers (device manufacturers), regulators, and other healthcare stakeholders on the specifics of collecting fit\u2010for\u2010purpose RWD and using RWE for regulatory decision\u2010making. We report on a unique approach to medical device regulatory review called the Open Hand Initiative, by which the US Food and Drug Administration (FDA) and device manufacturers collaborate to ensure the appropriate use of RWD\/RWE to support regulatory decision\u2010making. Normally, regulatory submission interactions are confidential; in the Open Hand approach, device manufacturers share high\u2010level learnings from pre\u2010submission interactions to advance the use of reliable and relevant RWD\/RWE for regulatory decision\u2010making. In a pilot study, the Open Hand approach was applied to pre\u2010submission interactions regarding the use of RWD\/RWE for transition of SARS\u2010CoV\u20102 serology IVDs with Emergency Use Authorization (EUA) to full market authorization. Participants in the pilot agreed that the candid discussions were key to identifying barriers to efficient, timely, and robust RWE generation for IVD premarket submissions. The pilot also led to valuable lessons learned around current regulatory requirements for RWE, SARS\u2010CoV\u20102 testing complexities, and the impact that the rapidly evolving COVID\u201019 pandemic had on RWD availability and quality. The Open Hand Initiative can be applied more broadly to guide device manufacturers in collecting high\u2010quality RWD to generate RWE for premarket applications.<\/jats:p>","DOI":"10.1002\/cpt.3539","type":"journal-article","created":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T04:05:53Z","timestamp":1735013153000},"page":"1072-1077","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The Open Hand Initiative: Facilitating the Use of Real\u2010World Evidence in Regulatory Submissions Through Collaboration and Transparency"],"prefix":"10.1002","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7169-1855","authenticated-orcid":false,"given":"Elodie","family":"Baumfeld Andre","sequence":"first","affiliation":[{"name":"Roche Diagnostics Santa Clara California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3931-0625","authenticated-orcid":false,"given":"Matthew","family":"Gee","sequence":"additional","affiliation":[{"name":"Siemens Healthcare Diagnostics Inc. Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1125-2783","authenticated-orcid":false,"given":"Carsten","family":"Magnus","sequence":"additional","affiliation":[{"name":"F. Hoffmann\u2010La Roche Ltd Roche Information Solutions \u2013 Data & Analytics Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Greeman","sequence":"additional","affiliation":[{"name":"Roche Diagnostics Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pipper","family":"White","sequence":"additional","affiliation":[{"name":"Medical Device Innovation Consortium (MDIC) Arlington Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryellen","family":"de Mars","sequence":"additional","affiliation":[{"name":"Medical Device Innovation Consortium (MDIC) Arlington Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brad","family":"Spring","sequence":"additional","affiliation":[{"name":"Becton Dickinson Sparks Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,24]]},"reference":[{"key":"e_1_2_11_1_1","unstructured":"Cassidy M.Smith introduce bipartisan legislation to harness real\u2010world evidence in FDA approval process. Accessed November 27 2024."},{"key":"e_1_2_11_2_1","unstructured":"US Food and Drug Administration.Real\u2010world evidence. Accessed April 20 2022."},{"key":"e_1_2_11_3_1","unstructured":"US Food and Drug Administration&Center for Devices and Radiological Health.Examples of real\u2010world evidence (RWE) used in medical device regulatory decisions. Accessed April 20 2022."},{"key":"e_1_2_11_4_1","unstructured":"US Food and Drug Administration.Draft: use of real\u2010world evidence to support regulatory decision\u2010making for medical devices(2023) . Accessed January 10 2024."},{"key":"e_1_2_11_5_1","unstructured":"US Food and Drug Administration&Center for Devices and Radiological Health.Use of real\u2010world evidence to support regulatory decision\u2010making for medical devices. Accessed April 20 2022."},{"key":"e_1_2_11_6_1","unstructured":"US Food and Drug Administration&Department of Health and Human Services.Medical device classification procedures. Determination of safety and effectiveness. Code of Federal Regulations 21CFR860.7. Accessed April 19 2022."},{"key":"e_1_2_11_7_1","unstructured":"Medical Device Innovation Consortium.Real\u2010world clinical evidence generation: advancing regulatory science and patient access for In\u00a0Vitro Diagnostics (IVDs). Accessed April 20 2022."},{"key":"e_1_2_11_8_1","unstructured":"US Food and Drug Administration.National Evaluation System for health Technology (NEST). Accessed January 10 2024."},{"key":"e_1_2_11_9_1","unstructured":"National Evaluation System for health Technology Coordinating Center (NESTcc)(2024) . Accessed January 10 2024."},{"key":"e_1_2_11_10_1","unstructured":"Businesswire.Medical device innovation consortium releases real\u2010world evidence framework for in\u00a0vitro diagnostics. Accessed April 20 2022."},{"key":"e_1_2_11_11_1","unstructured":"Medical Device Innovation Consortium.Systemic Harmonization and Interoperability Enhancement for Lab Data (SHIELD). Accessed April 20 2022."},{"key":"e_1_2_11_12_1","unstructured":"Centers for Disease Control and Prevention.Diagnostic data & reporting(2021) . Accessed December 13 2022."},{"key":"e_1_2_11_13_1","unstructured":"Our World in Data.Coronavirus (COVID\u201019) vaccinations. Accessed December 13 2022."},{"key":"e_1_2_11_14_1","unstructured":"World Health Organization.WHO\/BS\/2022.2427: establishment of the 2nd WHO international standard for anti\u2010SARS\u2010CoV\u20102 immunoglobulin and reference panel for antibodies to SARS\u2010CoV\u20102 variants of concern(2022) . Accessed December 13 2022."},{"key":"e_1_2_11_15_1","unstructured":"Centers for Disease Control and Prevention.Guidance for antigen testing for SARS\u2010CoV\u20102 for healthcare providers testing individuals in the community(2022) . Accessed December 13 2022."},{"key":"e_1_2_11_16_1","unstructured":"Federal Register.Revocation of eleven authorizations of emergency use of in\u00a0vitro diagnostic device for detection and\/or diagnosis of COVID\u201019; Availability. Accessed January 10 2024."},{"key":"e_1_2_11_17_1","unstructured":"US Food and Drug Administration.Humanitarian device exemption(2024) . Accessed November 2."},{"key":"e_1_2_11_18_1","unstructured":"US Food and Drug Administration.Monkeypox (mpox) emergency use authorizations for medical devices. Accessed November 26 2024."},{"key":"e_1_2_11_19_1","unstructured":"Medical Device Innovation Consortium.MDIC IVD RWE education series. Module 1(2021) . Accessed April 20 2022."}],"container-title":["Clinical Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.3539","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,11]],"date-time":"2025-08-11T09:21:55Z","timestamp":1754904115000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.3539"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,24]]},"references-count":19,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/cpt.3539"],"URL":"https:\/\/doi.org\/10.1002\/cpt.3539","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,24]]},"assertion":[{"value":"2024-05-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}