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Clinical Trial Challenges in the COVID-19 era. A Thread
Logistical challenges: enrolment window is short
- need to fast track all procedures (writing, IRB, regulatory approval, funding application)
- drug needs to be available (favors "repurposing" or use of "off the shelf agents")
- placebo must be available, or use open-label design
- need to fast track all procedures (writing, IRB, regulatory approval, funding application)
- drug needs to be available (favors "repurposing" or use of "off the shelf agents")
- placebo must be available, or use open-label design
Ethical challenges
- Is « compassionate » use of unproven Rxs acceptable outside of clinical trials ?
- Can the standard of care be changed based on observational data ?
- When and how should one announce trial results ?
Press releases ?
Pre Prints ?
Peer reviewed Ms ?
- Is « compassionate » use of unproven Rxs acceptable outside of clinical trials ?
- Can the standard of care be changed based on observational data ?
- When and how should one announce trial results ?
Press releases ?
Pre Prints ?
Peer reviewed Ms ?
Which outcome should be targeted ?
Overall mortality is low for outpatients and > 98.5% of patients will survive
Surrogate outcomes are problematic:
e.g. viral load: pts clear the virus eventually
e.g. fever duration or viral load can be disconnected from clinical outcomes
Overall mortality is low for outpatients and > 98.5% of patients will survive
Surrogate outcomes are problematic:
e.g. viral load: pts clear the virus eventually
e.g. fever duration or viral load can be disconnected from clinical outcomes
Avoid waste and duplication:
- need for national and international coordination of efforts.
- need coordination of results: ideally real-time sharing of patient level data in shared repositories and coordination of DSMBs
- need for national and international coordination of efforts.
- need coordination of results: ideally real-time sharing of patient level data in shared repositories and coordination of DSMBs
Need transparent and fair reporting
- availability of protocols
- balanced and cautious results presentation both in scientific and lay media, given high public expectations (this needs collaboration between trialists and social scientists)
- availability of protocols
- balanced and cautious results presentation both in scientific and lay media, given high public expectations (this needs collaboration between trialists and social scientists)
@APHP @Inserm @Univ_Paris @yazdanpanah_y @nathanpsmad @xJeunemaitre @UP_Medecine @DLBHATTMD @HeartBobH @califf001 @EricTopol @eantman @texhern @MartinLandray
Credit is due
- Califf RM, Hernandez AF, Landray M.JAMA. 2020;324(7):625–626.
- Petkova E, Antman EM, Troxel AB. Pooling Data From Individual Clinical Trials in the COVID-19 Era. JAMA. 2020;324(6):543–545. doi:10.1001/jama.2020.13042
@JAMA_current
- Califf RM, Hernandez AF, Landray M.JAMA. 2020;324(7):625–626.
- Petkova E, Antman EM, Troxel AB. Pooling Data From Individual Clinical Trials in the COVID-19 Era. JAMA. 2020;324(6):543–545. doi:10.1001/jama.2020.13042
@JAMA_current
