Introduction to Confirmatory Trials
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Confirmatory Trials sentence examples within Randomized Confirmatory Trials
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
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If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
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Confirmatory Trials sentence examples within Perform Confirmatory Trials
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
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5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
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Confirmatory Trials sentence examples within Cancer Confirmatory Trials
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
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In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
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Confirmatory Trials sentence examples within Controlled Confirmatory Trials
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
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Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
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Confirmatory Trials sentence examples within Prospective Confirmatory Trials
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
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Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
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Confirmatory Trials sentence examples within Iv Confirmatory Trials
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
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As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
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Confirmatory Trials sentence examples within Larger Confirmatory Trials
Confirmatory Trials sentence examples within Required Confirmatory Trials
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
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Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
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Confirmatory Trials sentence examples within confirmatory trials published
Confirmatory Trials sentence examples within confirmatory trials failed
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Full Text
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
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More Confirmatory Trials sentence examples
10.1158/1078-0432.CCR-20-4555
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
Full Text
More Confirmatory Trials sentence examples
10.1158/1078-0432.CCR-20-4555
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
If it has been demonstrated that exposure is related to a relevant clinical outcome, such as efficacy or toxicity, and that exposure can be optimized by PK-guided dosing, it could be logically assumed that PK-guided dosing would result in better treatment outcomes without the need for randomized confirmatory trials.
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More Confirmatory Trials sentence examples
10.1002/pst.2103
Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits.
Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits.
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More Confirmatory Trials sentence examples
10.1002/pst.2103
Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits.
Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits.
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More Confirmatory Trials sentence examples
10.1136/annrheumdis-2021-220164
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
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More Confirmatory Trials sentence examples
10.4103/kjo.kjo_202_20
ADs can be applied from early-phase trials to confirmatory trials.
ADs can be applied from early-phase trials to confirmatory trials.
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More Confirmatory Trials sentence examples
10.1136/annrheumdis-2021-220164
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
5 Thus, ARD spearheaded the field by providing new, thoroughly peerreviewed findings at an early stage of our understanding of COVID-19 treatment so that others could perform confirmatory trials and patients could benefit timely from this advance.
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More Confirmatory Trials sentence examples
10.4103/kjo.kjo_202_20
ADs can be applied from early-phase trials to confirmatory trials.
ADs can be applied from early-phase trials to confirmatory trials.
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10.1002/pst.2093
Assessment of efficacy in important subgroups – such as those defined by sex, age, race and region – in confirmatory trials is typically performed using separate analysis of the specific subgroup.
Assessment of efficacy in important subgroups – such as those defined by sex, age, race and region – in confirmatory trials is typically performed using separate analysis of the specific subgroup.
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More Confirmatory Trials sentence examples
10.1002/pst.2093
Assessment of efficacy in important subgroups – such as those defined by sex, age, race and region – in confirmatory trials is typically performed using separate analysis of the specific subgroup.
Assessment of efficacy in important subgroups – such as those defined by sex, age, race and region – in confirmatory trials is typically performed using separate analysis of the specific subgroup.
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More Confirmatory Trials sentence examples
10.1007/s40265-021-01512-2
As with other approvals under the Accelerated Approval Program, continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
As with other approvals under the Accelerated Approval Program, continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
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10.1007/s40265-021-01512-2
As with other approvals under the Accelerated Approval Program, continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
As with other approvals under the Accelerated Approval Program, continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
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More Confirmatory Trials sentence examples
10.3390/cancers13112757
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
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More Confirmatory Trials sentence examples
10.3390/cancers13112757
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
In this study, we describe the methods and designs of breast cancer confirmatory trials published between 2001 and 2020.
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More Confirmatory Trials sentence examples
10.1186/s13063-021-05160-5
Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.
Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.
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More Confirmatory Trials sentence examples
10.1186/s13063-021-05160-5
Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.
Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.
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More Confirmatory Trials sentence examples
10.1007/s00122-021-03909-9
This model was applied to predict the performance of the entire set of 3024 accessions, and the top predicted performers were sent to Madagascar for confirmatory trials.
This model was applied to predict the performance of the entire set of 3024 accessions, and the top predicted performers were sent to Madagascar for confirmatory trials.
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More Confirmatory Trials sentence examples
10.1007/s00122-021-03909-9
This model was applied to predict the performance of the entire set of 3024 accessions, and the top predicted performers were sent to Madagascar for confirmatory trials.
This model was applied to predict the performance of the entire set of 3024 accessions, and the top predicted performers were sent to Madagascar for confirmatory trials.
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10.1158/2159-8290.CD-ND2021-0106
The FDA's Accelerated Approval program is under scrutiny after four drug companies announced plans in recent months to withdraw indications for checkpoint inhibitors that, despite showing early promise, failed to demonstrate a survival benefit in confirmatory trials.
The FDA's Accelerated Approval program is under scrutiny after four drug companies announced plans in recent months to withdraw indications for checkpoint inhibitors that, despite showing early promise, failed to demonstrate a survival benefit in confirmatory trials.
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10.1158/2159-8290.CD-ND2021-0106
The FDA's Accelerated Approval program is under scrutiny after four drug companies announced plans in recent months to withdraw indications for checkpoint inhibitors that, despite showing early promise, failed to demonstrate a survival benefit in confirmatory trials.
The FDA's Accelerated Approval program is under scrutiny after four drug companies announced plans in recent months to withdraw indications for checkpoint inhibitors that, despite showing early promise, failed to demonstrate a survival benefit in confirmatory trials.
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More Confirmatory Trials sentence examples
10.1177/1534735421997551
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
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More Confirmatory Trials sentence examples
10.1177/1534735421997551
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
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10.2139/ssrn.3894909
Further investigation of PB-201 100 mg twice daily in confirmatory trials is warranted.
Further investigation of PB-201 100 mg twice daily in confirmatory trials is warranted.
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10.2139/ssrn.3894909
Further investigation of PB-201 100 mg twice daily in confirmatory trials is warranted.
Further investigation of PB-201 100 mg twice daily in confirmatory trials is warranted.
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10.1093/ajcn/nqab081
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
Full Text
More Confirmatory Trials sentence examples
10.1093/ajcn/nqab081
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
Although these findings require replication in both retrospective and prospective confirmatory trials, they emphasize the need to incorporate similar genetic analyses of choline-related polymorphisms in other FASD-choline trials, and to test for similar associations within the general FASD population.
Full Text
More Confirmatory Trials sentence examples
10.1136/bmj.n1462
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
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10.1093/cid/ciab732
These results warrant further validation in larger confirmatory trials.
These results warrant further validation in larger confirmatory trials.
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10.1136/bmj.n1462
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.
Full Text
More Confirmatory Trials sentence examples
10.1093/cid/ciab732
These results warrant further validation in larger confirmatory trials.
These results warrant further validation in larger confirmatory trials.
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10.36118/pharmadvances.2021.13
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
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10.1101/2021.06.02.21257838
However, one of the barriers to the uptake of Bayesian adaptive designs for confirmatory trials is limited experience with how they may perform compared to a frequentist design.
However, one of the barriers to the uptake of Bayesian adaptive designs for confirmatory trials is limited experience with how they may perform compared to a frequentist design.
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10.36118/pharmadvances.2021.13
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
Over the past 6 years, the FDA has approved six ICIs for more than 75 oncological indications (35 through an accelerated pathway), and the term “dangling accelerated approvals” was coined: duplicates or similar indications for which the required confirmatory trials failed to show a clear benefit, and yet their marketing authorization continued [3].
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10.1101/2021.06.02.21257838
However, one of the barriers to the uptake of Bayesian adaptive designs for confirmatory trials is limited experience with how they may perform compared to a frequentist design.
However, one of the barriers to the uptake of Bayesian adaptive designs for confirmatory trials is limited experience with how they may perform compared to a frequentist design.
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10.1177/02698811211008567
Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice.
Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice.
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10.1177/02698811211008567
Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice.
Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice.
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10.1245/s10434-021-10847-9
In confirmatory trials, the rates of missed residual cancer [false-negative rates (FNRs)] were unacceptably high (> 10%).
In confirmatory trials, the rates of missed residual cancer [false-negative rates (FNRs)] were unacceptably high (> 10%).
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10.1245/s10434-021-10847-9
In confirmatory trials, the rates of missed residual cancer [false-negative rates (FNRs)] were unacceptably high (> 10%).
In confirmatory trials, the rates of missed residual cancer [false-negative rates (FNRs)] were unacceptably high (> 10%).
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Confirmatory Test
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