Clinical trials in the pandemic age: What is fit for purpose?

Abstract

It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups. We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.

Model‐informed drug repurposing: A pharmacometric approach to novel pathogen preparedness, response and retrospection

“…Benjamin Franklin offered the advice that "an ounce of prevention is worth a pound of cure". 23 This axiom is assumed to relate to health, but in fact it was put forward as advocacy for fire awareness and prevention. More broadly, his advice relates to disaster preparedness and advocates, as do these authors, performing as much work as feasible ahead of the disaster.…”

“…In a special communication, Hartman et al seek to address this through standardization of informative endpoints and accessibility to master protocols. 23 Therefore, in the preparatory stage, best practice and highly efficient trial designs or master template protocols should be developed, focusing on establishing optimal dosing of RDs and combinations of RDs (Table 1, Step 4). Without central organization and access to readily available protocols, disparate, non-comparative, unaligned and underpowered studies will spring up to fill that void, as seen throughout the COVID-19 pandemic.…”

“…24 During the responsive phase, efficient trials should be executed in a transparent manner and the results communicated quickly to shape new and adapt ongoing trials. 23 Finally, in the retrospective stage, trial design best practices should be updated based on the learnings from the pandemic and implemented in preparation for the next NP.…”

“…The MIDR strategy proposed in this manuscript, will allow not only the retrospective evaluation of drug effects for drug repurposing, but will also allow tools and strategies to be developed in preparation for future pandemic events.These steps can also be organized around implementation relative to the NP's emergence. Benjamin Franklin offered the advice that "an ounce of prevention is worth a pound of cure" 23. This axiom is assumed to relate to health, but in fact it was put forward as advocacy for fire awareness and prevention.…”

Commentary on Meyers et al: Ethically prioritizing trials in the COVID-19 era – practical considerations

“…7 Institutions should focus on addressing disparities in COVID-19 and should explicitly prioritize studies addressing underserved populations such as specific racial or ethnic groups, rural communities, people with disabilities, or workers in essential industries, among others. 8,9 Prioritizing these studies includes an institutional commitment to ensuring they receive the resources needed to engage these communities throughout the research continuum, to enroll patients from these groups, and to prioritize studies where successful interventions will be accessible. Special consideration should be given to studies that can address disparities that are being exacerbated by the pandemic.…”