Methodology for analysis of the 66 studies registered to ClinicalTrials.gov from 2000 to 2017 that met criteria for inclusion
| Process step . | Variable . |
|---|---|
| Accrual duration (D) of each study from ClinicalTrials.gov | D = (estimated primary completion date − study start date)/365.25 |
| The average number of patients needed to be enrolled per year (Q) to correspond to the estimated (or completed) enrollment number | Q = Estimated Enrollment (or completed enrollment)/D |
| Estimated average number of patients accrued in each year of study | Pij = (Q / 12 mo) * number of months study accrual was active that year (Mi) |
| i = active year; j = NCT number. | |
| Months were included in Mi for dates ≤15th and were excluded in Mi for dates >15th | |
| Estimate for number of patients needed for enrollment in final study year | Pij (last year of study) = Estimated (or Completed) Enrollment – Sum of all previous Pij |
| Process step . | Variable . |
|---|---|
| Accrual duration (D) of each study from ClinicalTrials.gov | D = (estimated primary completion date − study start date)/365.25 |
| The average number of patients needed to be enrolled per year (Q) to correspond to the estimated (or completed) enrollment number | Q = Estimated Enrollment (or completed enrollment)/D |
| Estimated average number of patients accrued in each year of study | Pij = (Q / 12 mo) * number of months study accrual was active that year (Mi) |
| i = active year; j = NCT number. | |
| Months were included in Mi for dates ≤15th and were excluded in Mi for dates >15th | |
| Estimate for number of patients needed for enrollment in final study year | Pij (last year of study) = Estimated (or Completed) Enrollment – Sum of all previous Pij |