The coronavirus pandemic has brought public attention to the steps required to produce valid scientific clinical research in drug development. Traditional ethical principles that guide clinical research remain the guiding compass for physicians, patients, public health officials, investigators, drug developers and the public. Accelerating the process of delivering safe and effective treatments and vaccines against COVID-19 is a moral imperative. The apparent clash between the regulated system of phased randomized clinical trials and urgent public health need requires leveraging innovation with ethical scientific rigor. We reflect on the Belmont principles of autonomy, beneficence and justice as the pandemic unfolds, and illustrate the role of innovative clinical trial designs in alleviating pandemic challenges. Our discussion highlights selected types of innovative trial design and correlates them with ethical parameters and public health benefits. Details are provided for platform trials and other innovative designs such as basket and umbrella trials, designs leveraging external data sources, multi-stage seamless trials, preplanned control arm data sharing between larger trials, and higher order systems of linked trials coordinated more broadly between individual trials and phases of development, recently introduced conceptually as "PIPELINEs."
Keyphrases
- public health
- sars cov
- coronavirus disease
- clinical trial
- end stage renal disease
- healthcare
- respiratory syndrome coronavirus
- big data
- ejection fraction
- randomized controlled trial
- chronic kidney disease
- phase ii
- mental health
- decision making
- study protocol
- phase iii
- electronic health record
- peritoneal dialysis
- global health
- double blind
- transcription factor
- prognostic factors
- newly diagnosed
- magnetic resonance
- drinking water
- health information