Dataset Information

Managing Clinical Trials for Alzheimer's Disease During the COVID-19 Crisis: Experience at Fundacio ACE in Barcelona, Spain.

ABSTRACT: BACKGROUND:The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. OBJECTIVE:To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. METHODS:We describe participants' clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. RESULTS:A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. DISCUSSION:The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.

SUBMITTER: Abdelnour C

PROVIDER: S-EPMC7683041 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Managing Clinical Trials for Alzheimer's Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain.

Abdelnour Carla C Esteban de Antonio Ester E Pérez-Cordón Alba A Lafuente Asunción A Buendía Mar M Pancho Ana A Jofresa Sara S Aguilera Nuria N Ibarria Marta M Cuevas Rosario R Cañada Laia L Calvet Anna A Diego Susana S González-Pérez Antonio A Orellana Adela A Montrreal Laura L de Jorge Laura L Marquié Marta M Benaque Alba A Gurruchaga Miren M Tárraga Lluís L Ruiz Agustín A Boada Mercè M

Journal of Alzheimer's disease : JAD 20200101 4

<h4>Background</h4>The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries.<h4>Objective</h4>To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes.<h4>Methods</h4>We describe participants' clinica ...[more]

PMID: 32986671

Similar Datasets

Project description:BackgroundThe COVID-19 pandemic strained healthcare systems immensely as of 2020. Switzerland's hospital pharmacies' responses during the first wave were surveyed with a view to improving the quality of pharmaceutical management in future health crises.MethodsAn online survey was sent to the heads of all of Switzerland's hospital pharmacies. The questionnaire was organised into eleven sections of questions covering many topics regarding the management of COVID-19's first wave. Data collection occurred from May to June 2020.ResultsAnalyses were performed using the 43 questionnaires (66%), with at least one answer per questionnaire, out of 65 distributed. Seventeen of 41 pharmacies responding (41%) had existing standard operating procedures or pandemic plans and 95% of these (39/41) set up crisis management steering committees. Twenty-nine of 43 pharmacies responding (67%) created new activities to respond to the pandemic's specific needs. Twenty-six of 39 pharmacies responding (67%) created new drug lists for: COVID-19-specific treatments (85%; 22/26), sedatives (81%; 21/26), anaesthetics (77%; 20/26) and antibiotics (73%; 19/26). Drug availability in designated COVID-19 wards was managed by increasing existing stocks (54%; 22/41 pharmacies) and creating extra storage space (51%; 21/41). Two drugs generated the greatest concern about shortages: propofol (49%; 19/39 pharmacies) and midazolam (44%; 17/39). Remdesivir stocks ran out in 26% of pharmacies (10/39). Twelve of 43 pharmacies (28%) drafted specific new documents to respond to medical needs regarding drug administration, 12 (28%) did so for drug preparation and 10 (23%) did so for treatment choices.ConclusionsSwitzerland's hospital pharmacies encountered many challenges related to the COVID-19 crisis and had to find solutions quickly, effectively and safely. The survey highlighted the key role that hospital pharmacies played in many aspects of the pandemic by providing logistical and clinical support to medical and nursing care teams. The lessons and experiences outlined could be used to improve the quality of hospital pharmacies' readiness for similar future events.

Dataset Information

Managing Clinical Trials for Alzheimer's Disease During the COVID-19 Crisis: Experience at Fundacio ACE in Barcelona, Spain.

Publications

Managing Clinical Trials for Alzheimer's Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets