Table 1 Additional variables calculated concerning the period of obtaining ethics approval and the screening and trial period
Variable | Calculation |
|---|---|
Time necessary for ethics/IRB approval (days) | a - b |
Time between ethics/IRB approval and start trial (days) | c - a |
Screening period (days) | f - e |
Enrolment/trial period (days) | d - c |
Total number of patients in screening period (n per month) | g/(f - e) |
Number of eligible patients in screening period (n per month) | h/(f - e) |
Proportion eligible patients of total in screening period (%) | (h/g) * 100 |
Total number of patients per month in trial period (n per month) | (i + j)/(d - c) |
Number of inclusions in trial period (n per month) | i/(d - c) |
Proportion inclusions of total in trial period (%) | (i/(i + j)) * 100 |
Proportion patients that were missed for registration in trial period of total (%) | (k/(i + j + k)) * 100 |
Rate of total number of patients per month in trial period versus screening period | ((i + j)/(d - c))/(g/(f - e)) |
Rate of number of inclusions/eligible patients per month in trial period versus screening period | (i/(d - c))/(h/(f - e)) |
Rate of percentage inclusions/eligible patients per month in trial period versus screening period | ((i/(i + j) * 100)/((h/g) * 100) |