Dear All,
I wonder if you can please advise me what the conventions are for reports for Trial Steering Committee/TSCs and unblinded and blinded sections of Data Monitoring Committees/DMC meetings during clinical trials.
I am particularly interested in what tables are produced and are they split by treatment arm.
There are various types of data collected in a clinical trial.
1) demographic eg gender, age, ethnic group
2) clinical data of various types
i) baseline data of clinical variables eg BMI, BP (if a stroke or CVD trial BP might be in iii) )
ii) follow up data of clinical variables
iii) baseline values of variables that are endpoints or closely related to endpoints (primary or secondary)
iv) post baseline data that comprise the trial endpoints - or are closely related to them
v) recruitment figures
vi) (S)AEs
vii) numbers of participants who die or withdraw from trial, or from treatment or other intercurrent events (these may be part of endpoints)
I may have missed some data types.
I am interested in what set of tables are produced for each of the 3 settings and are they split by treatment arm or not and whether comparisons are made eg p-value. I know in part its obvious - we don't present efficacy split by arm with a p-value to the TSC or the blinded TSC.
Some issues aren't clear to me - is there a difference in the tables for the TSC and blinded part of the DMC ?
eg can we show the treatment split of demographic demographic variables in the TSC and blinded part of the DMC or is treatment splits never allowed there ??
can we show the baseline values of efficacy type variables in the TSC and blinded part of the DMC (or in only 1 of those) eg baseline differences in fasting plasma glucose or PSA or tumour sizes ?
Are there clear guidelines on these ? I've not found them - I have found stuff on trial committee roles and types fo participant and general conduct but nothing specific on tables for each type
Does it depend on whether the trial arms are blinded to participants ie often "patients" (even if it is the arms may well not be blinded to trial investigators, statisticians or endpoint assessors)
many thanks in advance
I wonder if you can please advise me what the conventions are for reports for Trial Steering Committee/TSCs and unblinded and blinded sections of Data Monitoring Committees/DMC meetings during clinical trials.
I am particularly interested in what tables are produced and are they split by treatment arm.
There are various types of data collected in a clinical trial.
1) demographic eg gender, age, ethnic group
2) clinical data of various types
i) baseline data of clinical variables eg BMI, BP (if a stroke or CVD trial BP might be in iii) )
ii) follow up data of clinical variables
iii) baseline values of variables that are endpoints or closely related to endpoints (primary or secondary)
iv) post baseline data that comprise the trial endpoints - or are closely related to them
v) recruitment figures
vi) (S)AEs
vii) numbers of participants who die or withdraw from trial, or from treatment or other intercurrent events (these may be part of endpoints)
I may have missed some data types.
I am interested in what set of tables are produced for each of the 3 settings and are they split by treatment arm or not and whether comparisons are made eg p-value. I know in part its obvious - we don't present efficacy split by arm with a p-value to the TSC or the blinded TSC.
Some issues aren't clear to me - is there a difference in the tables for the TSC and blinded part of the DMC ?
eg can we show the treatment split of demographic demographic variables in the TSC and blinded part of the DMC or is treatment splits never allowed there ??
can we show the baseline values of efficacy type variables in the TSC and blinded part of the DMC (or in only 1 of those) eg baseline differences in fasting plasma glucose or PSA or tumour sizes ?
Are there clear guidelines on these ? I've not found them - I have found stuff on trial committee roles and types fo participant and general conduct but nothing specific on tables for each type
Does it depend on whether the trial arms are blinded to participants ie often "patients" (even if it is the arms may well not be blinded to trial investigators, statisticians or endpoint assessors)
many thanks in advance
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