RECIST stands for Response Evaluation Criteria in Solid Tumors and serves guidance for assessing tumor shrinkage and disease progression, an important endpoint in many Oncology Clinical Trials. Currently, the revised version is RECIST v1.1, published in 2008 (Eisenhauer E.A. et al) and is used by Physicians, Statisticians, and Clinical Scientists to assess Response of subjects and desired outcomes in a clinical trial.
The investigator determines a maximum of fiv... read more...
There are various types of endpoints designed to get meaningful conclusion in clinical trial. These endpoints can be
Continuous E.g. Change from baseline in blood sugar after 6 month of treatment
Binary - E.g. Response or no response
Time to event - E.g. Time to progression of tumor, time to hospitalization
Counts - E.g. Frequency of occurrence of AE
Today, we'll talk about binary endpoints in clinical trial.
As name says, binary, there are 2 possible outcomes. E.g. response vs. no re... read more...
Patient profile is a listing of all (or selected, sometime) data for individual subject in clinical study organized by time. Subject can be patient or healthy volunteer, though it is referred as Patient Profiles. Patient profiles are optional in submission to FDA.
However, patient profiles were recommended to submit in pdf file in CRT (Case Report Tabulation) to FDA previously (as per guideline for Providing Regulatory Submissions in Electronic Format, 1999). Patient profiles are not expected i... read more...
SAS Clinical Solutions
Let's continue SAS Clinical Solutions with SAS log's ERROR, Warning and Notes handling. We show in previous blog about ERRORS and now, let's discuss on WARNINGS and NOTES
a. WARNING: Multiple lengths were specified for the variable state by input data set(s). This may cause truncation of data.
1. Assign length statement before the set statement.
2. You can also use - opti... read more...