11. Closed vs. Open
Trial Planning & Design Example
Reality
• Distant from practice
• Small number
• Slow and expensive
• Naïve
Today’s Closed Fortress Model:
• Internal product teams
• Advisors
• Third party organizations
• Competitive = Secret
Time to explore other models
12. Experiment Portfolio
• Open Clinical Intelligence Network
– Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
13. Open Clinical Intelligence Network
Commons Licensing
3. Curate
4. Connect1. Collect
Clinical
Knowledge
Generation
2. Consume
Uncurated
Data
Curated
Data
Crowd
Public Data
Motivation
Technology
Worldbank
ROAR
14. Open Clinical Intelligence Network
Knowledge Generating System
Krohn & Crist Whitepaper
Trial
Site
Publication
Drug
Disease
Regulatory
Timeline
Geographic
Network Diagram
Scatter Plot
Export
API
Search/Filter
Annotate
Correct
Cross Link
API
Social Share
Collaborate
External Data
Gamification
Commons Licensing
3. Curate
4. Connect1. Collect
Clinical
Knowledge
Generation
2. Consume
Uncurated
Data
Curated
Data
Crowd
Public Data
22. So What?
If...
– Incremental improvement is a slow death,
– Competitive mindset is stopping collaboration, and,
– Closed model is part of the problem…
Then…check your assumptions:
– Incremental vs. Disruptive
– Precompetitive vs. Competitive
– Closed vs. Open
23. Time to Engage!
Tide is rising for disruptive change.
Are you on board?
The case is clear
The opportunities are many
The question is leadership
60 percent of all protocols for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars.More than half of all protocols require one or more amendments, with the higher number occurring duringPhase III.One-third of all amendments involve protocol description and patient eligibility criteria. Median total cycle time to identify and resolve a protocol problem is 61 days.
Definition: describing the early stages of the development of a commercial product, during which competitors collaborate
Naïvea) Public registries and transparency initiativesb) Public disclosure: part of being a public companyc) People same external advisors such as therapeutic key opinion leaders. same third party organizations such as consultants or CROs, and the same operational sites to execute our research. d)same sources for complementary investment funding. people are people. Missing the mark: Operationally: 60% get amendments Scientifically: Patient Impact
