Clinical

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
*********************WARNING************************;

a. WARNING: Multiple lengths were specified for the variable state by input data set(s). This may ca 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 pe 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 read more..

Background:

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 asses read more..