Open CT

2 minute read • updated September 26, 2018

Major trends

The cost, time, and risk to bring new treatments to market has increased, even as our scientific and analytical capabilities have advanced. Treatments are becoming increasingly targeted and even personalized, taking into account both genetics and personal history.

Hypothesis

The market for clinical research systems is highly consolidated, with only a few major players — Oracle, Medidata — dominating the market. In line with their business models and strategic positions, these incumbents pursue a closed strategy in which they restrict or entirely prevent third party interoperability with their systems. This approach has been very successful in suppressing the emergence of new entrants, and at the same time it has allowed the incumbents to avoid investment in innovation and new functionality. The net effect: a stagnant market in which customers — pharma companies and CROs — have few options, and many unmet business needs.

We have proposed an open system for clinical trials, one based on three pillars:

  • A new system for software compliance validation
  • A shared backbone that provides a common data model, shared APIs, authorization, and interoperability between functional components
  • Transparent governance that encourages innovation by allowing different developers to implement functional modules, while also ensuring quality and compliance

Story

While it’s valuable - in business and human health terms - to reduce the cost, risk, and time to perform clinical trials, the real payoff is in enabling high quality, compliant clinical research to be performed by organizations that don’t have the resources to do so with the current systems. If truly successful, not only will OpenCT make it possible to run existing trials designs much more cheaply, but it will provide the platform on which to develop wholly new functionality to support new kinds of trials.

The ultimate outcome of the OpenCT vision, therefore, is a world in which many more actors are able to develop and test treatments for illnesses of all types. This would mean that many ailments for which it is not currently economical to develop new treatments – those considered “rare”, or those afflicting underserved or poor populations – could be addressed and, potentially, cured.

What we have validated

In partnership with a major pharma sponsor, we have completed several rounds of design and strategy work on the OpenCT concept. Like many of their peers, this sponsor does not view their R&D platform as IP which provides differentiation, but rather a cost and risk center. They recognize that the current solutions do not - and will not - serve their evolving needs, but they do not have the capabilities in-house to create an alternative, nor do they believe that the usual development vendors are capable of delivering innovative solutions.

Risks and Questions

  • Are the needs of different customers / sponsors sufficiently similar to provide viable early development targets?
  • Will pharma competitors be willing to cooperate to the extent needed to create a vibrant marketplace?
  • What is the proper division of responsibility between software vendors, the governance body, and the managed service providers who will operate instances of the system?
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