{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T11:13:15Z","timestamp":1788952395641,"version":"build-2803163510"},"reference-count":29,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>\n                    Healthy volunteers (HVs) are essential for phase I trials, yet their recruitment and screening remain resource\u2010intensive and ethically complex. High screening failure (SF) rates highlight the need to evaluate and understand all aspects of the enrolment processes. We analyzed SF patterns in a large German HV cohort and explored participants' motivations, risk perceptions, and expectations regarding trial participation and screening procedure. We retrospectively evaluated screening results from phase I trials (2012\u20132022) at Heidelberg University Hospital. Additionally, we performed a prospective mixed\u2010methods assessment with semi\u2010structured interviews and a questionnaire evaluating recruitment, informed consent (IC), motivation, and decision making, distributed to experienced volunteers of four trial sites (October 2024\u2013August 2025). Across 30 phase I trials, 900 volunteers were screened with a SF rate of 31.9% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009287), mainly due to laboratory abnormalities, medical history of concern, and organizational issues. Results from five semi\u2010structured interviews and the questionnaire survey (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009196) showed an overall acceptable satisfaction with the IC process, but identified areas of improvement in weighting of topics and risk perception. Although financial compensation was voted as the most important motivation, the decision process is multifactorial and an interplay of compensation, organizational aspects, and expected risks. We identified trial characteristics that are modifiable to facilitate interest in trial participation and provide data\u2010driven recommendations to improve the ethical, efficient, and operational conduct of phase I trials. Furthermore, the results underline the relevance of addressing public perceptions and misconceptions surrounding clinical trials to improve willingness to engage in early\u2010phase research.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70462","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T10:29:48Z","timestamp":1788949788000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-8636-7993","authenticated-orcid":false,"given":"Evelyn","family":"Krohmer","sequence":"first","affiliation":[{"name":"Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University\/Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7502-6685","authenticated-orcid":false,"given":"Manuela","family":"K\u00f6nig","sequence":"additional","affiliation":[{"name":"Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University\/Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-5584-6677","authenticated-orcid":false,"given":"Cathrin J.","family":"Vogt","sequence":"additional","affiliation":[{"name":"Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University\/Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8815-1702","authenticated-orcid":false,"given":"Marina","family":"Streckebein","sequence":"additional","affiliation":[{"name":"CRS hVIVO  Mannheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7024-536X","authenticated-orcid":false,"given":"Sybille","family":"Baumann","sequence":"additional","affiliation":[{"name":"CRS  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9816-0445","authenticated-orcid":false,"given":"Max","family":"Blumenstock","sequence":"additional","affiliation":[{"name":"Institute of Medical Informatics Heidelberg University  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1007-3011","authenticated-orcid":false,"given":"Ruwen","family":"B\u00f6hm","sequence":"additional","affiliation":[{"name":"Socratec  Erfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0483-0293","authenticated-orcid":false,"given":"Fabian","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG  Biberach an der Ri\u00df Germany"},{"name":"Institute of Experimental and Clinical Pharmacology and Toxicology Friedrich\u2010Alexander\u2010Universit\u00e4t Erlangen\u2010N\u00fcrnberg  Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3403-1636","authenticated-orcid":false,"given":"Nadja","family":"Stru\u00df","sequence":"additional","affiliation":[{"name":"Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University\/Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-1227-8670","authenticated-orcid":false,"given":"Viktoria S.","family":"Wurmbach","sequence":"additional","affiliation":[{"name":"Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University\/Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8743-5194","authenticated-orcid":false,"given":"Antje","family":"Blank","sequence":"additional","affiliation":[{"name":"Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology Medical Faculty Heidelberg University\/Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,9]]},"reference":[{"key":"e_1_2_13_1_1","unstructured":"European Medicines Agency.Regulation (EU) No 536\/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001\/20\/EC Text with EEA relevance(2014)."},{"key":"e_1_2_13_2_1","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1001\/jama.2024.21972","article-title":"Declaration of Helsinki: ethical principles for medical research involving human participants","volume":"333","author":"World Medical Association","year":"2025","journal-title":"JAMA"},{"key":"e_1_2_13_3_1","doi-asserted-by":"crossref","first-page":"1647","DOI":"10.1007\/s00228-022-03366-3","article-title":"Perception of clinical research among patients and healthy volunteers of clinical trials","volume":"78","author":"Bergmann F.","year":"2022","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"e_1_2_13_4_1","doi-asserted-by":"crossref","first-page":"137","DOI":"10.4103\/2229-3485.184820","article-title":"Challenges in recruitment and retention of clinical trial subjects","volume":"7","author":"Kadam R.A.","year":"2016","journal-title":"Perspect. Clin. Res."},{"key":"e_1_2_13_5_1","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1016\/j.cct.2010.12.003","article-title":"More than the money: a review of the literature examining healthy volunteer motivations","volume":"32","author":"Stunkel L.","year":"2011","journal-title":"Contemp. Clin. Trials"},{"key":"e_1_2_13_6_1","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1177\/1740774517722130","article-title":"Motivations, enrollment decisions, and socio\u2010demographic characteristics of healthy volunteers in phase 1 research","volume":"14","author":"Grady C.","year":"2017","journal-title":"Clin. Trials"},{"key":"e_1_2_13_7_1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0256994","article-title":"Healthy volunteers in US phase I clinical trials: sociodemographic characteristics and participation over time","volume":"16","author":"Kalbaugh C.A.","year":"2021","journal-title":"PLoS One"},{"key":"e_1_2_13_8_1","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1177\/1740774519834257","article-title":"Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration","volume":"16","author":"Tadros R.","year":"2019","journal-title":"Clin. Trials"},{"key":"e_1_2_13_9_1","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1007\/s00228-016-2189-8","article-title":"Who is a \u2018healthy subject\u2019?\u2010consensus results on pivotal eligibility criteria for clinical trials","volume":"73","author":"Breithaupt\u2010Groegler K.","year":"2017","journal-title":"Eur. J. Clin. 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Pharmacol."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70462","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70462","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70462","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T10:29:52Z","timestamp":1788949792000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70462"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,9]]},"references-count":29,"alternative-id":["10.1002\/cpt.70462"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70462","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,9]]},"assertion":[{"value":"2026-05-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"cpt.70462"}}