{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T15:05:00Z","timestamp":1721142300040},"reference-count":4,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T00:00:00Z","timestamp":1619740800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T00:00:00Z","timestamp":1619740800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Res Methodol"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>During the COVID-19 emergency, IRST IRCCS, an Italian cancer research institute and promoter of no profit clinical studies, adapted its activities and procedures as per European and national guidelines to maintain a high standard of clinical trials, uphold participant safety and guarantee the robustness and reliability of the data collected. This study presents the measures adopted by our institute with the aim of providing information that could be useful to other academic centers promoting clinical trials during the pandemic.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Main text<\/jats:title>\n                <jats:p>After an in-depth analysis of European and Italian guidelines and consultation and analysis of publications regarding the actions implemented by international no profit clinical trial promoters during the emergency, we monitored the way in which the institute managed clinical trials, verifying compliance with regulatory guidelines and clinical procedures, and evaluating screening and recruitment trends in studies. During the pandemic, our center activated a new clinical trial for the treatment of patients with COVID-19. A number of procedural changes in clinical trials were also authorized through notified amendments, in accordance with Italian Medicines Agency (AIFA) guidelines. Patient screening and enrolment was not interrupted in any site participating in multicenter interventional clinical trials on drugs. The institute provided clear indications about essential procedures to be followed, identifying those that could be postponed or carried out by telephone\/teleconference. All external sites were monitored remotely, avoiding on-site visits. Although home-working was encouraged, the presence of staff in the central office was also guaranteed to ensure the continuity of promoter activities.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Some measures adopted by IRST could also be effective outside of the COVID-19 period, e.g. numerous activities relating to clinical trial management could be performed on a home-working basis, using suitable digital technologies. In the future, electronic medical records and shared guidelines will be essential for the correct identification and management of trial risks, including the protection of the rights and privacy of subjects taking part. Promoter supervision could be increased by implementing centralized monitoring tools to guarantee data quality. Closer collaboration between promoters and local study staff is needed to optimize trial management.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12874-021-01291-0","type":"journal-article","created":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T15:04:44Z","timestamp":1619795084000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials"],"prefix":"10.1186","volume":"21","author":[{"given":"Linda","family":"Valmorri","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernadette","family":"Vertogen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara","family":"Zingaretti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Miserocchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberta","family":"Volpi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto","family":"Clemente","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabella","family":"Bondi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene","family":"Valli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Britt","family":"Rudnas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanni","family":"Martinelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oriana","family":"Nanni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,4,30]]},"reference":[{"key":"1291_CR1","unstructured":"Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic. Version 3, 28\/04\/2020. https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf. Accessed 8 Sept 2020."},{"issue":"6","key":"1291_CR2","doi-asserted-by":"publisher","first-page":"1232","DOI":"10.19540\/j.cnki.cjcmm.20200.501","volume":"45","author":"H Wang","year":"2020","unstructured":"Wang H, Jin XY, Pang B, Liu CX, Zheng WK, Yang FW, et al. Analysis on clinical study protocols of traditional Chinese medicine for coronavirus disease 2019. Zhongguo Zhong Yao Za Zhi. 2020;45(6):1232\u201341. https:\/\/doi.org\/10.19540\/j.cnki.cjcmm.20200.501.","journal-title":"Zhongguo Zhong Yao Za Zhi"},{"issue":"15","key":"1291_CR3","doi-asserted-by":"publisher","first-page":"E405","DOI":"10.1503\/cmaj.200438","volume":"192","author":"MP Cheng","year":"2020","unstructured":"Cheng MP, Lee TC, Tan DHS, Murthy S. Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic. CMAJ. 2020;192(15):E405\u20137. https:\/\/doi.org\/10.1503\/cmaj.200438.","journal-title":"CMAJ"},{"key":"1291_CR4","unstructured":"Guidance of the management. of clinical trials during the covid-19 (coronavirus) pandemic. Version 2, 27\/03\/2020. https:\/\/www.ibima.eu\/wp-content\/uploads\/2020\/04\/Guidance-on-the-Management-of-Clinical-Trials-during-the-COVID-vers2.pdf. Accessed 8 Sept 2020."}],"container-title":["BMC Medical Research Methodology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12874-021-01291-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12874-021-01291-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12874-021-01291-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T15:04:58Z","timestamp":1619795098000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedresmethodol.biomedcentral.com\/articles\/10.1186\/s12874-021-01291-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,30]]},"references-count":4,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["1291"],"URL":"https:\/\/doi.org\/10.1186\/s12874-021-01291-0","relation":{},"ISSN":["1471-2288"],"issn-type":[{"value":"1471-2288","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4,30]]},"assertion":[{"value":"13 November 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 April 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 April 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"91"}}