Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry. On March 11th, 2020 the World Health Organization declared the novel coronavirus disease-2019
outbreak a global pandemic.
Coronaviruses are non-segmented positive-sense ribonucleic acid viruses in the Coronaviridae family, which typically affects the respiratory, gastrointestinal, hepatic and neurologic systems. Under Food and Drug Administration expanded access programs and federal emergency guidelines, COVID-19 clinical trials have been some of the most successful trials to date.
The focus of this paper is to bring into context the strategic thinking of C-level executives in the biotechnology and CRO industry when faced with a global pandemic and decision-making process considering the critical need of FDA expedited timelines, potential need for expanded access for emergency use, and clinical site expansion to meet the endpoints of the registered clinical study.
This analysis will incorporate two case studies, Humanigen based in Burlingame, California, USA as well as Durect in Cupertino, California, USA. HUMANIGEN considered the data coming out of Wu et al1 article that eighty-four patients developed ARDS, and of those patients, died. In those who developed ARDS, compared with those who did not, more patients presented with dyspnea.
That is, a company might have a drug under investigation for another therapeutic indication and will reach out to a CRO to re-write the IND (and eventually submit a new one) for COVID-19. Two, submitting an IND for COVID-19 is expeditious because the biotech does not have to write a completely new IND.
Clin Trial Pract Open J. 2021; 4(1): 10-12. doi: 10.17140/CTPOJ-4-118