Patient numbers

Protocol Name Patient Number - Visit Identifier ... 

Protocol Name Patient Number - Patient Initials ... 

Protocol Name Patient Number Visit Identifier... 

SUBJECT = PATIENT NUMBER, SAMPDATE = LAB SAMPLE DATE,... 

SUBJECT = PATIENT NUMBER, LAB TEST = LABORATORY TEST NAME, LAB DATE = LAB COLLECTION DATE, LAB RESULT = LAB VALUE. data labs ... 

INPUT SAMPLE DEATH DATA WHERE SUBJECT = PATIENT NUMBER AND... 

INPUT SAMPLE BLOOD PRESSURE VALUES WHERE SUBJECT = PATIENT NUMBER, WEEK = WEEK OF STUDY, AND TEST = SYSTOLIC (SBP) OR DIASTOLIC (DBP) BLOOD PRESSURE. data bp ... 

SUBJECT = PATIENT NUMBER, SEIZURE = BOOLEAN FLAG INDICATING A SEIZURE AND SEIZDATE = DATE OF SEIZURE. data seizure informat seizdate date9. format seizdate date9. label subject = "Patient Number" seizdate = "Date of Seizure" seizure = "Seizure l=Yes,0=No" input subject seizure seizdate datalines ... 

SUBJECT = PATIENT NUMBER AND DOSEDATE = DRUG DOSING DATE. data dosing ... 

Obs Start of Drug Therapy Patient Number End of Study Date Date of Seizure Seizure 1=Yes,0=No Days to Seizure or Censor Day... 

Two recent studies seem to further validate the preceding hypothesis, insofar that in the first study, Lp(a) levels in women with peripheral vascular disease were significantly higher than in controls in the second study, there was a trend toward higher levels in men that did not reach statistical significance (N8). The same trend was reported in another study from Spain, in which patient numbers were small (N7). 

In addition to the methods reviewed in this chapter there has been the development of a procedure known as meta-analysis, which seeks to combine as many clinical studies as possible in a formal and structured way, so that patient numbers may be increased to a level at which conclusions may be drawn that would not be possible from single studies. Needless to say, there are strongly held views both for and against meta-analysis, but at present it would probably be true to say that the jury is stiU out. 

The priority review is applicable for orphan drugs, orphan medical devices and innovative drugs or medical devices that have been authorised to be highly necessary from a medical standpoint. The standards to define orphan drugs are the following (1) patient number of disease indicated for the drug concerned is less than 50 000 (2) excellent usefulness of the drug from the medical standpoint and (3) the development... 

All serious adverse events, deviations from the protocol, extensions of study period or increase in patient numbers should be reported to the head of the institute by the investigator. 

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