Unclear if IPD is needed or CSRs – please see comments below.Not Approve
This is an interesting proposal to meta-analyze RCT data examining interventions used to treat recurrent ovarian cancer. Unfortunately, this proposal is poorly written, preventing sufficient understanding of the investigators’ approach and methods. In fact, multiple sections of the proposal were copied and pasted, leading to redundant text without clarifying specifically: the project background and significance; the specific aims of the project; the data sources to be used along with the inclusion/exclusion criteria (including: the investigators request only 2 trials – what additional trials will be available for this meta-analysis? how will this data be obtained? if the other trials will be limited to published reports, why is IPD for the 2 requested trials needed? would CSRs be sufficient for purposes of this work?); the dichotomous main outcome measures (specifically, at what time period will these be ascertained and will this information be available for all trials, just the requested trials, and so forth); statistical analysis (specifically, will you use fixed or random effects?); and a clear narrative summary for the general public (this narrative summary includes information on inclusion criteria as currently written – but how will RCTs of these interventions be searched for and identified?).
Also, please provide definitions for PS ECOG status, PFI Length and please avoid abbreviations as much as is possible (or at least define them with first use).