Clinical trials in the pandemic age: What is fit for purpose?
Dan HartmanPenny HeatonNick CammackIan HudsonShawn DolleyElena NetsiThea NormanTrevor MundelPublished in: Gates open research (2020)
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.
Keyphrases
- coronavirus disease
- sars cov
- public health
- clinical trial
- end stage renal disease
- respiratory syndrome coronavirus
- ejection fraction
- physical activity
- newly diagnosed
- chronic kidney disease
- healthcare
- phase iii
- prognostic factors
- study protocol
- phase ii
- mental health
- randomized controlled trial
- type diabetes
- global health
- small molecule
- case report
- emergency department
- current status
- peripheral blood
- double blind
- social media
- metabolic syndrome
- patient reported