E vidence-based Feasibility
For each Evidence-based Feasibility (EbF), detailed individual patient data is collected by CDDI from a sample of investigator sites representative of the geographical distribution of the study.
We take care of the entire process (contracts, institutional approvals, etc.) to obtain this data. The collected data is used for an independent analysis, simulating accrual for protocols and PIPs.
​Participating investigators are interviewed to discuss the patient data and to provide expert feedback on design, operational issues and the attractiveness of the protocol.
​
The individual steps behind each EbF are described below:
1. REACH OUT TO INVESTIGATOR SITES
A list of investigator sites is provided by the Sponsor and / or carefully selected by CDDI. We contact all individual sites, sending them a Fact Sheet with a short description of the EbF project.
2. CONTRACT EXECUTION
In case of a positive initial response, a CDA is signed and we hold an introductory meeting to provide more details. If the investigator agrees to participate, a contract is executed and we go through the data protection approval process, where needed.
3. CHART REVIEW & DATA COLLECTION IN EDC
De-identified data related to eligibility criteria is collected by investigators and / or study nurses. The screening module of an EDC system is used for data entry. Quality control is done by CDDI.
4. DATA ANALYSIS
CDDI analyses the data to provide insight into the number of patients excluded per criterion. Simulations of accrual are run following potential changes to eligibility criteria. Suggestions are given to optimise the final protocol and increase accrual.
5. MEETING WITH INVESTIGATOR
Structured interviews are held with each participating investigator to review the collected data. Feedback is elicited on design, operational issues and the attractiveness of the protocol.
6. FINAL OUTPUT & PROTOCOL FINALIZATION
CDDI provides a final report including the outcome of all analyses and simulations to the Sponsor, together with the investigator feedback. The Sponsor's clinical team uses the input to fine-tune the protocol prior to finalization… or to support Pediatric Investigational Plans (PIP).
