- On 29 Απριλίου 2020
Health care systems and Health Care Professionals are in a warpath to curb the coronavirus pandemic without proven pharmacological treatments and no available vaccine to prevent SARS-CoV-2 infection.
Due to the high risk public health emergency, several repurposed drugs and investigational agents are being studied in clinical trials for their safety and efficacy as treatments and or pre-exposure or post-exposure prophylactic strategies as registered in WHO ICTRP. In parallel ,a rich COVID-19 vaccine pipeline of novel DNA, mRNA & other candidates are mainly in preclinical research or in early clinical development – Phase I, with a vaccine becoming available still 12-18 months away.
An unprecedented spirit of international collaboration has led to important coalitions pursuing acceleration of COVID-19 R&D to control SARS-CoV-2 infection under WHO coordination.
Namely the newly founded COVID-19 Clinical Research Coalition will synergize with existing initiatives, such as the COVID-19 Therapeutics Accelerator, the Coalition for Epidemic Preparedness Innovations (CEPI), and the SARS-CoV-2 Diagnostic Pipeline, to ensure research interventions are well designed ,properly sized and adequately powered to generate robust evidence, to tackle COVID -19 infection.
A special mention is due to the Solidarity Trial, an international adaptive controlled trial comparing four treatments, launched by WHO and its partners, which is expected to deliver evidence in the coming 12-16 weeks.
Moreover a close collaboration on COVID-19 observational research and real world data between international medicines regulators was announced post a virtual global regulatory workshop organized by the umbrella coalition ICMRA and co -chaired by Health Canada and EMA. ICMRA brings medicine regulators worldwide to exchange information, build synergies for expediting COVID-19 medicines, vaccine development and approval.
During these challenging times, the research community ecosystem has exercised vigorous Open Science, Transparency and Data Sharing practices for combatting the SARS-CoV-2 pandemic.
Varvara Baroutsou, MD, PhD, Internist, EMAUD, GFMD
President of Greek Society of Pharmaceutical Medicine –EL.E.F.I. – www.elefi.gr
April 26, 2020