key: cord-0752827-2tcvntm4
authors: Filippis, Giuseppe De
title: Optimising effectiveness of health care and value of clinical trials in the COVID -19 outbreak
date: 2020-06-02
journal: Pharmacol Res
DOI: 10.1016/j.phrs.2020.104993
sha: e3fc1e926eae534fcb99c6004556e8f01628636f
doc_id: 752827
cord_uid: 2tcvntm4

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. The COVID-19 pandemic is proving to be the worst health catastrophe of this century so far: Its spread is having very significant effects not only on health, with a high number of deaths and infected patients, but also on the global economy, with rising unemployment and increased poverty; it also brought psychological implications, because of a high increase in cases of posttraumatic stress syndrome (1). These effects were immediately evident in Lombardy, which is the Italian region most affected by the outbreak. The seriousness of the pandemic immediately highlighted among those who had decision-making roles how its management should be approached according to the principles of crisis management. Crisis management is the process by which an organisation manages a disruptive and unexpected event that threatens to damage the organisation or the parties concerned (2). Three elements are common to a crisis: (a) a threat to the organisation, (b) the surprise element, and (c) a short decision time.

Management requires on the one hand the ability to make quick decisions; on the other hand the search and application of different organizational models compared to those previously applied.

In Italy, on February 20, 2020, a 38-year-old man was admitted with acute respiratory insufficiency to the intensive care unit (ICU) of the Codogno Hospital, a small town in Lombardy nearby Milan, marking the beginning of the SARS-CoV2 epidemic in Italy. The sudden massive inflow of patients overwhelmed existing protocols in place to handle rapidly evolving emergency situations. In order to adequately respond to the quick and wide spreading of the SARS-CoV2 infection, hospitals needed new strategic organisational planning. Hospitals had to quickly change their patient management skills by reviewing their organisation across all sectors (3). Intensive care and sub intensive care beds for patients with respiratory problems had to be increased (4). All hospitalisations for non-urgent patients not infected by SARS-CoV2 had to be suspended and essentially all medical and nursing staff were involved in the management of patients affected by COVID-19.

In parallel with the review of the organisational aspects, the research sector also had to change its approach, especially by accelerating planning of clinical trials and their authorisation phases, and in the request for informed consent. Especially at the beginning it was of fundamental importance to concentrate efforts to increase the diagnostic, etio-pathogenic and therapeutic knowledge of the virus. All this has seen a huge effort also by researchers. Despite the emergency, some fundamental concepts were reiterated for the respect of the cardinal principles of scientific research. 

As for the collection of informed consent from each patient, while reiterating its obligatory nature, novel approaches were devised in Italy in order to enable the researchers to proceed quickly in the collection of information useful for scientific research, such as the use of verbal authorisation made by the patient in front of witnesses or in case this was not possible authorisation granted by the patient after the conditional collection of biological samples. Italy also adopted temporary regulatory changes during the pandemic period, on the one hand to speed up the approval of clinical studies, on the other to coordinate them. The Italian Medicines Agency (Agenzia Italiana del Farmaco -AIFA) adopted extraordinary and simplified procedures for the presentation and approval of the trials and for the definition of the methods for joining the studies and acquiring data. The Ethics Committee of the National Institute for Infectious Diseases Lazzaro Spallanzani in Rome was identified as the only national ethics committee for the evaluation of clinical trials of medicines for human use and medical devices for patients with COVID-19. The request and authorisation to import drugs for compassionate and off-label use was also simplified and speeded up.

In conclusion, scientific research and clinical trials must go hand in hand with clinical-assistance activities, even more during a pandemic period; these aspects are of great importance for those who have managerial and decision-making tasks, they are useful for scientific progress and health management and, in cases like COVID's, help to limit the spread of the infection and its consequences on the population. In the present circumstances all this was achieved without forsaking the principles of ethics and transparency that must never be overlooked.

The Psychological Impact of Quarantine and How to Reduce It: Rapid Review of the Evidence

Crises and Crisis Management: Integration, Interpretation, and Research Development

Checklist for hospitals preparing for the reception and care of coronavirus 2019 (COVID-19) patients

Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience and forecast during an emergency response

European Medicines Agency -Committee for Medicinal Products for Human Use: A call to pool EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19 -16

Italian National Institute of Health (Istituto Superiore di Sanità) Recommendations for collection, transport and storage of COVID-19 biological samples. Version of April 15, 2020. ISS COVID-19 Translational Research Working Group