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Data Mining to Make Global Feasibility Assessment More Reliable David J. Cocker, Senior Partner MDCPartners , Belgium. Feasibility means different things to different people. This presentation. Evolving clinical trial landscape information newly available via the internet
Data Mining Disclosure
An avalanche of new information will descend upon us
Slope publication count going forward
Normalized publication count
Artifact of retrospective trial registration
Five year lag
However, with a relatively sophisticated industry approach to knowledge management, metrics and analysis…
Why do we get this so wrong, so often?
Invest in in-depth feasibility
The cost of a focus group to discuss likes and dislikes of a study proposal is less than 4,000 EUR. To set up one site is between $50,000 and $80,000.
Throwing more money at feasibility. Will it improve reliability?
A study in diffuse large B cell lymphoma subjects who recently completed R-CHOP therapy.
Internal Clinical team assumptions
76 sites to recruit 750 patients
4 subjects per site
Scanned 750 trials, 60,000 patient mass
Need 188 sites to recruit 750 patients
10 subjects per site
The simplest meta-analysis of a trial registry would have mitigated this poor initial assumption.
Company added another 67 sites
Two year delay
Where do they live?
Selection of site
Sites in area which may be suitable
My trial is rolling
Monitoring the clinical trial environment
We cannot escape a rolling feasibility process
Adding a new component to the feasibility formula
Predictive modeling and decision support tools
Global trial activity
Private historical data
Survey data solicited from
More disclosure, more transparency, more to come!
It’s not just about clinical research disclosure. It’s about the reality of internet information linking up.
The power of semantic web disambiguation
A better view of the environment without the emotion
Population Pool (210,000,000)
Population pool availability
Subject Travelling Distance(134 Km)
An age of information mobility may mean patient mobility
Site load for area 770/ 55 sites
Breast Cancer Phase ll
Information that is on the move, stays on the move. Monitor and re-visit often.
Let the robot do the legwork, and then debate the assumptions.
Trial Count (score)
Number of investigators - 220
Regional population – 3,500,000
Essen as a region
Number of investigators - 96
Regional population – 7,500,000
Disambiguating a trial registry can render a nice picture
Breast Cancer sites
Subject travel assumption
Trial experience in years
Estimated enrollment histogram
Average patients per site
Organization score based on internet footprint
Traffic light system to indicate site availability
Absolute number of patients per site accounting for incidence, catchment radius and screening failure
Ranking data, even if qualitative, allows a better basis for discussion than a crystal ball.
Competing sites in catchment area based on site criteria
The model is under stress
David J. Cocker
Product Specialist Clinical Business Intelligence Systems
Vluchtenburgstraat 5 2630 Aartselaar– Belgium
Office +32 (0) 3 870 97 50
Direct +32 (0) 3 870 97 72
Fax +32(0) 3 870 97 51