Protas Unified Clinical Trials Management Platform

Protas, a not-for-profit organisation, was formed in 2020 to transform the way clinical trials are run and to reduce the barriers to the discovery and licensing of new medicines. Large-scale randomized trials are powerful approaches to demonstrating the safety and efficacy of new medicines; the current Recovery trial used national datasets and large populations properly randomized to demonstrate the efficacy of dexamethasone in treating Covid in the most ill people as well as unequivocally demonstrating the lack of effect of hydroxyquinoline in the same patient group.

There is an opportunity for well-designed large-scale trials with randomization and clear outcomes to transform the cost of drug development. The excessive cost and complexity of the current clinical trial process has made development of new medicines (especially for common chronic conditions) a high-risk business. Phase 3 trials for drugs are very expensive (typically costing hundreds of millions of US Dollars and potentially over 1billion US Dollars). As a consequence of the very high cost, too few participants may be recruited, or the trial may be run for too short a period to demonstrate the full effect of the treatment. As a result, many pharmaceutical companies are re-directing their portfolios to treatments for rare diseases, the resultant lack of new treatments for common, chronic conditions will place a significant burden on healthcare systems and funders.

Well-designed trials, efficiently run can be completed typically a fraction of the average cost of a trial. To achieve this requires:

• Good design with focus on a few principal outcomes supported by follow up through health records;
• Efficient processes for running trials in as few locations as possible; and
• A unified IT system that supports data ingress, use and analysis, enables the entire process of running and monitoring the trial and complies with the regulatory and data use requirements of different national bodies.

Protas has the expertise and processes to deliver well-designed, efficiently run trials and now seeks to engage a provider to design, develop, deploy, operate, and support a new, globally available, highly configurable, first in class Unified Clinical Trials Management Platform (UCTMP). The functional and non-functional requirements of the future platform are articulated in the tender documentation. Once on contract, and through an Agile software development process, the chosen supplier will be required to define the individual implementation level requirements in collaboration with the Protas Product Team. Collaboration with the Protas Product Team will be further required during consecutive Agile sprints as platform functionality is iteratively designed, developed, and deployed in readiness for configuration for the first clinical trial. Continual verification and validation to regulatory standards will be required. As such, the contract covers development and concurrent operation and support of the platform as functionality is taken into use.

The future Protas UCTMP will be required to support all phases during the lifecycle of a typical clinical trial:

Phase 1 - Trial design.

Phase 2 - Prepare for delivery.

Phase 3 - Recruit to trial.

Phase 4 - Follow up.

Phase 5 - Close and analyse.

Phase 6 - Post-trial activities.

These phases are typical and provided as an illustration only. Clinical trial context is described in more detail in the draft Invitation to Participate in Dialogue (ITPD).

Protas' main business will be running trials for customers, but it may elect to license the UCTMP to customers to use in trials they conduct themselves (or with another third party) and Protas may be involved in training such customers (and/or another third party) in the use of UCTMP. As such, Protas expects to have the commercial freedom to license use of the UCTMP to other parties. The precise requirements that a customer of Protas may need will depend on the logistics of running a particular trial and the provider may therefore be required to provide services to Protas which are in support of a service which Protas provides to a customer (although such support and the terms of such support would be equivalent and no more onerous to those involved in a trial which Protas might run itself).

The UCTMP requirement is described functionally by 22 feature groups each with listed features and supporting detail. Additionally, a list of non-functional requirements describes the overarching properties required. The full set of requirements are set out in the Statement of Work (SoW) provided as part of the tender documents. Additional information: Price is not the only award criterion and all criteria are stated only in the procurement documents