Evidence-based Feasibility (EbF) is our process for determining the do-ability of a study protocol prior to its finalization through a real-world data analysis. Our aim is to ensure that the protocol is scientifically sound and operationally feasible, will require fewer Amendments, and recruits well and according to plan.
Sample of sites
A 10-20% sample of Investigators is carefully selected to represent the types of sites and geographical areas to be involved in the study. They are offered a fee for participation in the EbF.
Sample of sites
Investigators provide the de-identified clinical data by a retrospective chart review of a representative sample of the target patient population. This activity complies with US HIPAA, GDPR and other data protection regulations. Some institutions may require formal approval processes.
A “pre-screening visit” is set up in an EDC system using inclusion / exclusion criteria from the draft synopsis. The data is subsequently downloaded to a custom-built analysis tool programmed to show whether or not patients meet the criteria for inclusion.
Face to Face meetings
Meetings (F2F or virtual)
A second, key, component of this process
is a structured interview with each investigator contributing patient data.
This virtual or f2f meeting is led by a senior medical consultant. Protocol design, inclusion and exclusion criteria, patient- and site-oriented issues, the impact of competing studies and other topics relevant to a successful study are all reviewed.
Simulations are then run to demonstrate whether changes to eligibility criteria, or other components of the protocol would improve recruitment. This also provides accurate predictions of patient numbers per site.
What can be achieved with an EbF?
Identifies unnecessary barriers to execution, e.g. too strict inclusion / exclusion criteria; too many procedures….
Identifies issues to be fixed before protocol finalization
Good relationships with Investigators and site staff are consolidated
Interest in the protocol is raised
It predicts accrual more accurately, enabling number of sites to be optimized
Informs negotiations with regulators on what is possible
May identify a “fatal” flaw in the protocol
Why doesn't everyone do it?
CDDI has senior medical experts to drive the process and engage in peer-to-peer discussion with Investigators
Concern that sites will be reluctant to do it
In fact Investigators find the EbF process valuable. It focuses their attention on the protocol.
CDAs and contracts take a long time to put in place
CDDI uses a simplified CDA and Letter of Agreement (“contract”)
Up front investment of time, resource and budget
The process needs to be planned into the protocol drafting process at an early stage. There is a modest up-front investment to do the work, but…….big savings can be made through fewer protocol amendments, more accurate prediction of recruitment, less need to add sites and reduced project management costs.
Downstream activities from protocol feasibility using a similar methodology
Evidence-based Site Selection
Preliminary pre-screening of patients to increase accrual in a 2 Stages approach