Sponsor “checklist” of points for clarification prior to agreeing to take on role of sponsorship for international trials:
Rationale for international recruitment. Would need to have a good reason for wanting to recruit on an international level.
Cost-benefit analysis of international recruitment- needs to be worthwhile
Knowledge of local healthcare systems in terms of who is responsible for paying for treatment (consideration for if patients are responsible for paying how randomisation will work)
Acceptability of the trial protocol between countries, including potential cultural differences.
Confidence in the local ethical/regulatory environment, identification of local clinicians with track record in research
Definitive plans for how the trial will be run internationally including sufficient resources and realistic timelines
Number of patients to be recruited internationally compared to UK recruitment, does this need capping?
Knowledge of clinical care pathway in each country
A plan for safety reporting
If opting for a co-sponsorship, clear division of responsibilities
If opting for co-funding models, an assessment of reliability of potential funders
Points for consideration:
- Definition of sponsor
- Role of CI across international sites
- Differences with international sites in and outside of the EU
- Portfolio approach to indemnity
- In depth risk assessment