ABSTRACT
With traditional studies, there is usually a gap of 6 to 9 months between the end of one study (dened as last patient out or the collection of the last data point of the study) and the beginning of the next (dened as rst patient in or the randomization of the rst patient in the study). This time is required to collect the data, clean the data, lock the database, run the statistical analysis, interpret the data, run additional analysis, perform sensitivity analysis, conduct business analysis, design the next study, write the protocol, design the case report forms, label the drug, le the regulatory documents, obtain institutional review board approval, and enroll the patients.
