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Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic.
Love, Sharon B; Armstrong, Emma; Bayliss, Carrie; Boulter, Melanie; Fox, Lisa; Grumett, Joanne; Rafferty, Patricia; Temesi, Barbara; Wills, Krista; Corkhill, Andrea.
Afiliación
  • Love SB; MRC Clinical Trials Unit at UCL, 90 High Holborn, WC1V 6LJ, London, UK. s.love@ucl.ac.uk.
  • Armstrong E; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
  • Bayliss C; Cambridge Clinical Trials Unit, Coton House Level 6, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 0QQ, UK.
  • Boulter M; Nottingham Clinical Trials Unit, Building 42, University Park, Nottingham, NG7 2RD, UK.
  • Fox L; The Institute of Cancer Research - Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5NG, UK.
  • Grumett J; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
  • Rafferty P; Northern Ireland Clinical Trials Unit, Elliot Dynes Building, Royal Hospitals, Belfast, BT12 6BA, UK.
  • Temesi B; Manchester Clinical Trials Unit, The University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.
  • Wills K; Cancer Research UK & UCL Cancer Trials Centre, UCL, 90 Tottenham Court Road, London, W1T 4TJ, UK.
  • Corkhill A; Southampton Clinical Trials Unit, University of Southampton, MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.
Trials ; 22(1): 279, 2021 Apr 14.
Article en En | MEDLINE | ID: mdl-33853635
The COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in United Kingdom Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTUs) within the UK.The UKCRC Monitoring Task and Finish Group, comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring.Monitoring, required to protect the safety of the patients and the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMFs) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.The arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / COVID-19 / Consentimiento Informado Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / COVID-19 / Consentimiento Informado Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido