DEALL was founded in 2010 and was initiated by Jean Paul PM de Vries MD, PhD (VS), Jan Albert Vos MD, PhD (IR) from the St. Antonius Hospital in Nieuwegein, and Bram Fioole MD, PhD (VS) and Ruud AHM Aarts MD (IR) of the Maasstad Hospital in Rotterdam.
DEALL is capable of including large groups of patients in a relatively short period of time. It shares a large scientific database (web-based and according to all criteria of Good Clinical Practice) controlled by a team of experienced data managers, guaranteeing a minimal loss to follow up.
The DEALL team delivers the complete package of the clinical trials performed, from the initial concept through protocol draft and medical ethics approval to the performance of the trial itself and eventually the statistical analysis and writing and submission of the scientific manuscripts. The DEALL team currently consists of 2 of the largest (endo)vascular teaching hospitals in The Netherlands and will soon be expanded to 4 centers. For each trial the option exists to select additional centers to participate, based on appropriate experience in the procedure investigated.
Data collection is performed by specifically trained data managers (Nurse Practitioners and Physician Assistants) and statistical analysis is supervised by an on-site epidemiologist/medical statistician. External, independent safety monitoring committees will supervise each trial.
Naturally all individual trials, as well as the central anonymized database, conform GCP guidelines.
Each participating center will only have access to its own patients in the database. The data will only be pooled for statistical analysis or for scrutiny by the safety monitoring committees.
A rough estimate of the annual experience in the four primary DEALL participants is as follows:
|Iliac PTA / stenting||750|