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Author: Zhilin-Lanshan
The U.
Author: Zhilin-Lanshan
The U.
Author: Zhilin-Lanshan
The U.
In order to maximize the utility of the PRO information submitted, the sponsor should collect and analyze the following PRO data:
-Disease-related symptoms;
-Symptomatic adverse events;
-Overall side effects affect general measures
-Body function;
-Task function
In order to maximize the utility of the PRO information submitted, the sponsor should collect and analyze the following PRO data:
-Disease-related symptoms;
-Symptomatic adverse events;
-Overall side effects affect general measures
-Body function;
-Task function
The FDA stated that it sees the potential added value of incorporating PRO measurements of symptoms and functional effects into benefit risk assessments in appropriately designed trials.
The guidelines mark another proactive measure by the Oncology Center of Excellence (OCE) to encourage the systematic collection of patient experience data in cancer clinical trials
The'minimum expectations' for patient experience data
The guidelines mark another proactive measure by the Oncology Center of Excellence (OCE) to encourage the systematic collection of patient experience data in cancer clinical trials
The'minimum expectations' for patient experience data
The'minimum expectations' for patient experience dataThe guidelines mark another proactive measure by the Oncology Center of Excellence (OCE) to encourage the systematic collection of patient experience data in cancer clinical trials
In 2016, Paul Kluetz, the current deputy director of OCE, and FDA colleagues published an article encouraging separate PRO evaluations of the three core concepts in cancer clinical research (symptomatic adverse events, physical function, and disease-related symptoms) instead of Use static health-related quality of life tools
The draft guide discusses the considerations for tool selection and includes examples of tools in each of the five core areas (see table below)
"Clearly defined" PRO measurement
The draft guide discusses the considerations for tool selection and includes examples of tools in each of the five core areas (see table below)
"Clearly defined" PRO measurement
"Clearly defined" PRO measurementThe draft guide discusses the considerations for tool selection and includes examples of tools in each of the five core areas (see table below)
The guide points out that the PRO measurement measures of the core concepts should be clearly defined for clear and accurate analysis and labeling
Several factors should be considered when determining the PRO evaluation frequency of core concepts:
-Baseline evaluation, as a reference point for evaluating changes;
-Perform more frequent evaluations in the first few treatment cycles, and may reduce the frequency of evaluations in subsequent cycles;
-The frequency of evaluation should take into account the dosing schedule of the drug being studied;
-Different frequencies can be selected for each core concept
Test design
Test designSeveral factors should be considered when determining the PRO evaluation frequency of core concepts:
-Baseline evaluation, as a reference point for evaluating changes;
-Perform more frequent evaluations in the first few treatment cycles, and may reduce the frequency of evaluations in subsequent cycles;
-The frequency of evaluation should take into account the dosing schedule of the drug being studied;
-Different frequencies can be selected for each core concept
The FDA stated, “When using a modular method that can evaluate and analyze these elements separately, different evaluation frequencies can be selected to reduce the burden on patients
.
The standard method of evaluating frequency in the first year of treatment will help advanced cancer trials.
Consistency and interpretation
.
"
.
The standard method of evaluating frequency in the first year of treatment will help advanced cancer trials.
Consistency and interpretation
.
"
The FDA stated, “When using a modular method that can evaluate and analyze these elements separately, different evaluation frequencies can be selected to reduce the burden on patients
.
The standard method of evaluating frequency in the first year of treatment will help advanced cancer trials.
Consistency and interpretation
.
"
.
The standard method of evaluating frequency in the first year of treatment will help advanced cancer trials.
Consistency and interpretation
.
"
The guidelines include recommendations to reduce the amount of missing data and its impact on the interpretability of results
.
Prospective procedures should be developed, including training of researchers and patients, completion of monitoring strategies, and obtaining PRO data from patients in the event of early withdrawal from the study
.
Data collection methods that reduce the burden on patients should be considered, for example, electronic PRO acquisition outside the clinic
.
The reason for the loss of PRO data should be recorded and included in the analysis data set
.
In addition, the use of concomitant medications that may affect the interpretation of the results should be carefully recorded
.
.
Prospective procedures should be developed, including training of researchers and patients, completion of monitoring strategies, and obtaining PRO data from patients in the event of early withdrawal from the study
.
Data collection methods that reduce the burden on patients should be considered, for example, electronic PRO acquisition outside the clinic
.
The reason for the loss of PRO data should be recorded and included in the analysis data set
.
In addition, the use of concomitant medications that may affect the interpretation of the results should be carefully recorded
.
The guidelines include recommendations to reduce the amount of missing data and its impact on the interpretability of results
.
Prospective procedures should be developed, including training of researchers and patients, completion of monitoring strategies, and obtaining PRO data from patients in the event of early withdrawal from the study
.
Data collection methods that reduce the burden on patients should be considered, for example, electronic PRO acquisition outside the clinic
.
The reason for the loss of PRO data should be recorded and included in the analysis data set
.
In addition, the use of concomitant medications that may affect the interpretation of the results should be carefully recorded
.
.
Prospective procedures should be developed, including training of researchers and patients, completion of monitoring strategies, and obtaining PRO data from patients in the event of early withdrawal from the study
.
Data collection methods that reduce the burden on patients should be considered, for example, electronic PRO acquisition outside the clinic
.
The reason for the loss of PRO data should be recorded and included in the analysis data set
.
In addition, the use of concomitant medications that may affect the interpretation of the results should be carefully recorded
.
The guidelines also point out that PRO concepts beyond the FDA's five core PRO concepts may be of interest to other stakeholders, and may include other functional areas, such as social or emotional, which are part of the overall health-related quality of life
.
.
The guidelines also point out that PRO concepts beyond the FDA's five core PRO concepts may be of interest to other stakeholders, and may include other functional areas, such as social or emotional, which are part of the overall health-related quality of life
.
.
Non-inferiority and superiority statement
The inclusion of PRO data in the label will depend on the adequacy of the trial design and implementation, the advantages and limitations of the PRO tool in a given use environment, and the quality of the data
.
The statement of non-inferiority or equivalence between the two study groups of the core PRO measurement should be supported by evidence that the measurement is sufficiently sensitive and the trial design is reasonable, including an argument for the selected margin of non-inferiority
.
The superiority statement for the PRO endpoint must be pre-specified and tested in the trial
.
In addition, the rationale for the definition of the endpoint should be provided for FDA's review and comment before the start of the trial, including what constitutes a meaningful change
.
Non-inferiority and superiority statement
The inclusion of PRO data in the label will depend on the adequacy of the trial design and implementation, the advantages and limitations of the PRO tool in a given use environment, and the quality of the data
.
The statement of non-inferiority or equivalence between the two study groups of the core PRO measurement should be supported by evidence that the measurement is sufficiently sensitive and the trial design is reasonable, including an argument for the selected margin of non-inferiority
.
The superiority statement for the PRO endpoint must be pre-specified and tested in the trial
.
In addition, the rationale for the definition of the endpoint should be provided for FDA's review and comment before the start of the trial, including what constitutes a meaningful change
.
Non-inferiority and superiority statement
Non-inferiority and superiority statement
The inclusion of PRO data in the label will depend on the adequacy of the trial design and implementation, the advantages and limitations of the PRO tool in a given use environment, and the quality of the data
.
The statement of non-inferiority or equivalence between the two study groups of the core PRO measurement should be supported by evidence that the measurement is sufficiently sensitive and the trial design is reasonable, including an argument for the selected margin of non-inferiority
.
The superiority statement for the PRO endpoint must be pre-specified and tested in the trial
.
In addition, the rationale for the definition of the endpoint should be provided for FDA's review and comment before the start of the trial, including what constitutes a meaningful change
.
Exploratory PRO results that are not included in the statistical hierarchy results are considered descriptive and will be evaluated on a case-by-case basis for inclusion in the label
.
The FDA stated, “Generally speaking, without pre-designation and statistical testing, exploratory PRO results comparing treatment benefits are unlikely to support inclusion in product labels
.
”
.
The FDA stated, “Generally speaking, without pre-designation and statistical testing, exploratory PRO results comparing treatment benefits are unlikely to support inclusion in product labels
.
”
Exploratory PRO results that are not included in the statistical hierarchy results are considered descriptive and will be evaluated on a case-by-case basis for inclusion in the label
.
The FDA stated, “Generally speaking, without pre-designation and statistical testing, exploratory PRO results comparing treatment benefits are unlikely to support inclusion in product labels
.
”
.
The FDA stated, “Generally speaking, without pre-designation and statistical testing, exploratory PRO results comparing treatment benefits are unlikely to support inclusion in product labels
.
”
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