Achieving effective informed oversight by DMCs in COVID clinical trials.
J Clin Epidemiol
; 126: 167-171, 2020 10.
Article
in English
| MEDLINE | ID: covidwho-638330
ABSTRACT
Best practices of data monitoring committees (DMCs) in randomized clinical trials are well established. Independent oversight provided by DMCs is particularly important in trials conducted in public health emergencies, such as in HIV/AIDS or coronavirus epidemics. Special considerations are needed to enable DMCs to effectively address novel circumstances they face in such settings. In the COVID-19 pandemic, these include the remarkable speed in which data regarding benefits and risks of interventions are accumulated. DMCs must hold frequent virtual meetings, using state-of-the-art communication software that protects against risk for security breaches. Data capture and DMC reports should be focused on the most informative measures about benefits and risks. Because numerous clinical trials are being concurrently conducted in the COVID-19 setting, often addressing closely related scientific questions, structures for DMC oversight should be efficient and adequately informative. When these concurrently conducted trials are evaluating related regimens in related clinical settings, often individually underpowered for safety and having separate DMCs, processes should be implemented enabling these DMCs to share with each other emerging confidential evidence to better assess risks and benefits. Ideally a single DMC would monitor a portfolio of clinical trials or a trial with multiple arms, such as a platform trial.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Research Design
/
Clinical Trials as Topic
/
Coronavirus Infections
/
Clinical Trials Data Monitoring Committees
/
Betacoronavirus
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
J Clin Epidemiol
Journal subject:
Epidemiology
Year:
2020
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS