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Epidemiol Prev ; 44(5-6 Suppl 2): 51-59, 2020.
Article in Italian | MEDLINE | ID: covidwho-1068124


BACKGROUND: the Covid-19 pandemic has provoked a huge of clinical and epidemiological research initiatives, especially in the most involved countries. However, this very large effort was characterized by several methodological weaknesses, both in the field of discovering effective treatments (with too many small and uncontrolled trials) and in the field of identifying preventable risks and prognostic factors (with too few large, representative and well-designed cohorts or case-control studies). OBJECTIVES: in response to the fragmented and uncoordinated research production on Covid-19, the   italian Association of Epidemiology (AIE) stimulated the formation of a working group (WG) with the aims of identifying the most important gaps in knowledge and to propose a structured research agenda of clinical and epidemiological studies considered at high priority on Covid-19, including recommendations on the preferable methodology. METHODS: the WG was composed by 25 subjects, mainly epidemiologists, statisticians, and other experts in specific fields, who have voluntarily agreed to the proposal. The agreement on a list of main research questions and on the structure of the specific documents to be produced were defined through few meetings and cycles of document exchanges. RESULTS: twelve main research questions on Covid-19 were identified, covering aetiology, prognosis, interventions, follow-up and impact on general and specific populations (children, pregnant women). For each of them, a two-page form was developed, structured in: background, main topics, methods (with recommendations on preferred study design and warnings for bias prevention) and an essential bibliography. CONCLUSIONS: this research agenda represents an initial contribution to direct clinical and epidemiological research efforts on high priority topics with a focus on methodological aspects. Further development and refinements of this agenda by Public Health Authorities are encouraged.

COVID-19/epidemiology , Epidemiologic Research Design , Pandemics , Research , SARS-CoV-2 , Adult , Aged , COVID-19/drug therapy , COVID-19/therapy , Child , Epidemiology/organization & administration , Female , Humans , Italy/epidemiology , Male , Middle Aged , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Prognosis , Societies, Scientific , Therapeutic Equipoise
Contemp Clin Trials ; 102: 106214, 2021 03.
Article in English | MEDLINE | ID: covidwho-917234


Most crises, though difficult and challenging to address, offer opportunities for change and for development of new perspectives or approaches to deal with traditional strategies. The reaction to and the managing of the COVID-19 pandemic has provided a platform for evaluating how we quantify disease prevalence, incidence, time courses and sequellae as well as how well we plan, design, analyze and interpret health care associated data, including clinical trials and electronic medical records and health claims data. Whether the Covid-19 crisis provides opportunities to advance the fields of biostatistics and epidemiology in select ways remains to be seen. This article describes three areas of crises experienced by the author during a career in the regulation of pharmaceutical products and how they were responded to. Some suggestions for potential future opportunities in reaction to the Covid-19 crises are provided.

Biostatistics , COVID-19/epidemiology , Data Collection/methods , Epidemiology/organization & administration , Acquired Immunodeficiency Syndrome/drug therapy , Acquired Immunodeficiency Syndrome/epidemiology , Anti-HIV Agents/therapeutic use , Clinical Trials as Topic/organization & administration , Cooperative Behavior , Data Collection/standards , Drug Development/organization & administration , Drug Industry/organization & administration , Efficiency, Organizational , Epidemiology/standards , Humans , Incidence , Pandemics , Prevalence , SARS-CoV-2 , Time Factors , United States , United States Food and Drug Administration/organization & administration