Adapting to a Pandemic - Conducting Oncology Trials during the SARS-CoV-2 Pandemic.
Aaron C TanDavid M AshleyMustafa KhasrawPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2020)
The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has necessitated changes in cancer care delivery as resources are reallocated. Clinical trials and other research activities are inevitably impacted. Start-up activities for new trials may be deferred and recruitment suspended. For patients already enrolled however, there are challenges in continuing treatment on trial. Regulatory bodies have issued guidance on managing clinical trials during the pandemic, including contingency measures for remote study visits, delivery of investigational product, and site monitoring visits. New cancer clinical trial practices during the SARS-CoV-2 pandemic include new risk assessment strategies, decentralized and remote trial coordination, data collection, and delegation of specific therapeutic activities. This experience could provide evidence of more feasible and cost-effective methods for future clinical trial conduct.
Keyphrases
- sars cov
- clinical trial
- respiratory syndrome coronavirus
- phase ii
- phase iii
- study protocol
- open label
- risk assessment
- end stage renal disease
- double blind
- coronavirus disease
- chronic kidney disease
- newly diagnosed
- randomized controlled trial
- ejection fraction
- palliative care
- healthcare
- peritoneal dialysis
- papillary thyroid
- current status
- big data
- electronic health record
- heavy metals
- artificial intelligence
- squamous cell carcinoma
- deep learning
- patient reported outcomes
- squamous cell
- human health
- medical education
- smoking cessation