COVID-19 Trial -
Positive ways to see the Modified trial submission:
1.) FDA came back in < a week with guidance
2.) 10 centers vs. 2 cities
3.) Respiratory “Complications” vs. Gilead trial of “Severe” or “Moderate”
4.) increased from 4-6 weeks to ensure efficacy, sufficient time and safety
5.) 75 patients - a manageable # that allows faster expansion once shows efficacy with this group
Perhaps with questions around remdesivir’s use against COVID-19, the FDA has very mindfully framed the Leronlimab trial..IMHO and hopeful for all for success here!
Excerpt from Gilead’s trial:
“...The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing regimen of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone...”
From the NIH:
KEY CONCEPTS IN CLINICAL TRIAL DESIGN
Judgments about the effectiveness of a given intervention ultimately rest on an interpretation of the strength of the evidence arising from the data collected. In general, the more controlled the trial, the stronger is the evidence.
The study designs for clinical trials can take several forms, most of which are based on an assumption of accessible sample populations. Clinical trials of efficacy ask whether the experimental treatment works under ideal conditions. In contrast, clinical trials of effectiveness ask whether the experimental treatment works under ordinary circumstances. Often, trials of efficacy are not as sensitive to issues of access to care, the generalizability of the results from a study with highly selective sample of patients and physicians, and the level of adherence to treatment regimens. Thus, when a trial of efficacy is done with a small sample of patients, it is not clear whether the experimental intervention will be effective when a broader range of providers and patients use the intervention. On the other hand, trials of effectiveness can be problematic if they produce a negative result, in which case it will be unclear whether the experimental intervention would fail under any circumstances. Thus, the issue of what is preferred in a small clinical study—a trial of efficacy or effectiveness—is an important consideration.
Positive ways to see the Modified trial submission:
1.) FDA came back in < a week with guidance
2.) 10 centers vs. 2 cities
3.) Respiratory “Complications” vs. Gilead trial of “Severe” or “Moderate”
4.) increased from 4-6 weeks to ensure efficacy, sufficient time and safety
5.) 75 patients - a manageable # that allows faster expansion once shows efficacy with this group
Perhaps with questions around remdesivir’s use against COVID-19, the FDA has very mindfully framed the Leronlimab trial..IMHO and hopeful for all for success here!
Excerpt from Gilead’s trial:
“...The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing regimen of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone...”
From the NIH:
KEY CONCEPTS IN CLINICAL TRIAL DESIGN
Judgments about the effectiveness of a given intervention ultimately rest on an interpretation of the strength of the evidence arising from the data collected. In general, the more controlled the trial, the stronger is the evidence.
The study designs for clinical trials can take several forms, most of which are based on an assumption of accessible sample populations. Clinical trials of efficacy ask whether the experimental treatment works under ideal conditions. In contrast, clinical trials of effectiveness ask whether the experimental treatment works under ordinary circumstances. Often, trials of efficacy are not as sensitive to issues of access to care, the generalizability of the results from a study with highly selective sample of patients and physicians, and the level of adherence to treatment regimens. Thus, when a trial of efficacy is done with a small sample of patients, it is not clear whether the experimental intervention will be effective when a broader range of providers and patients use the intervention. On the other hand, trials of effectiveness can be problematic if they produce a negative result, in which case it will be unclear whether the experimental intervention would fail under any circumstances. Thus, the issue of what is preferred in a small clinical study—a trial of efficacy or effectiveness—is an important consideration.
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