The EXCITE International Process

Below is an overview of the process flow of the EXCITE International approach...

1. Call for Innovation Submissions

Applications to EXCITE International are accepted throughout the year. Promising technologies that align with our mandate are recommended to apply. We work closely with innovators to help them complete and submit robust applications.

Eligibility Criteria

Our current focus is to evaluate innovative medical devices that can significantly improve patient outcomes and/or improve health system efficiencies. Both multinational enterprises (MNEs) and small and medium enterprises (SMEs) are eligible to apply.

Applicant technologies may be pre-market or already licensed by regulatory organizations.

In general, the technologies should:

  • be beyond proof of principle and ready for clinical trials
  • have preliminary safety data
  • be ready for use in field evaluations and clinical trials

We do not evaluate pharmaceutical products, however, applications for companion diagnostics to inform pharmaceutical development or pharmacogenomic-targeted therapies may be considered.

2. Technology Screening/Prioritization Phase

The value to industry of early signaling and feedback on the alignment of technology to relevant stakeholder priorities is invaluable.  In this phase, comprehensive due diligence is conducted by the EXCITE International Secretariat before applications are brought forward to the various EXCITE International Stakeholder Committees: 

  • Payer Advisory Committee (PAC) – During this phase, the PAC will provide insight on potential interest within the marketplace of the proposed technology and early signal on a Payer’s interest in potential downstream reimbursement
  • International Scientific Collaboration (ISC) – The ISC is comprised of international experts within the scientific community who will guide the development of protocols and provide advice on developing high-quality multinational studies according to an inclusive approach to protocol design. The ISC’s role at this stage of the process will be to review any existing evidence that is submitted and provide guidance as to the scientific merit of the technological solution.  The ISC may recommend considerations that would strengthen the quality of ongoing evidence generation.
  • Optional: A formal evidence review of the value-add of the technology relative to other similar technologies may be requested by industry or strongly recommended by EXCITE International if there is uncertainty regarding the breakthrough nature of the technology or its potential impact on patient outcomes or health system efficiency. There is an additional fee for this which varies depending on the complexity of the analysis. This confidential, comprehensive report is provided to industry.

A summary report encapsulating stakeholder views on the predicted ability of the innovation to add value to patient outcomes and health systems will be provided to industry upon completion of this phase.

High potential technologies are then presented to the EXCITE International Board.  Prioritized technologies are recommended to continue through the EXCITE International process.  It is anticipated that the review and prioritization phase will take about two months to complete, depending on the complexity of the technology.

3. Protocol Development Phase

In the Protocol Development Phase, industry is matched with one of EXCITE International’s global methodological research centres (GMRCs) whose role it is to develop a custom clinical trial protocol that meets the needs of industry.  Multi-stakeholder feedback is gathered and incorporated into a comprehensive clinical trial protocol that reflects key endpoints of relevance.  These include:

  • North American and European Regulators who provide feedback on safety and efficacy considerations
  • Patient engagement through a variety of approaches that may include focus groups, advocacy groups and/or crowdsourcing
  • EXCITE International’s Payers’ Advisory Committee (PAC) that provides perspective on endpoints pertinent to reimbursement decisions
  • EXCITE International’s Scientific Collaboration (ISC) that provides ongoing feedback and oversight on trial design and overall protocol development
  • Human factors testing organizations that play an important role in maximizing safety and usability considerations 
  • EXCITE International Hubs represent the interests of the EXCITE International community in partner jurisdictions, and represent a full cross-section of key stakeholders within local geographies.

The cost for the Protocol Development Phase varies, depending on various factors including complexity of the technology, the scope of EXCITE International services to be included in the protocol, the number of sites and partners involved. Final pricing will be determined in collaboration with the GMRC and will be negotiated with and accepted by industry prior to initiation of work.

4. Evidence Generation Phase

Following regulatory and Research Ethics Board approvals, the GMRC implements the clinical trial protocol and is responsible for completing data collection and analysis as well as final reporting.  GMRCs leverage the network of EXCITE International Hubs to identify Key Opinion Leaders, clinical trial sites and potential pioneer sites for downstream uptake.

The cost for the Evidence Generation Phase is variable, based on project scope.

5. Global Adoption Phase

A unique feature of the EXCITE International process is early and ongoing engagement with payers, policy makers and healthcare delivery organizations.  Each payer determines the process they will use for adoption decision-making and implementation. This will differ by jurisdiction with the final decision on adoption being within the purview of each health system/organization. Although the EXCITE International process does not guarantee downstream adoption of innovative technology, we believe that our ongoing focus on multi-stakeholder collaboration and early engagement mitigates the risk of rejection by payers and decision makers.  In this way, patients and health systems alike will benefit from early access to impactful technologies capable of improving health outcomes and health system efficiencies.

The process of an EXCITE International review terminates after the EXCITE International Executive Board reviews the final report.   

Contact us now to discuss if EXCITE International can help you accelerate the adoption of your impactful health technology.

The Value of EXCITE International

Who Is Involved

Work with us. EXCITE International can assist you in facilitating multi-jurisdictional clinical trials through its partnership with government, clinical experts, methodology centres and health system decision makers.