CRED Clinical Trials - Day 1 handouts



Day1 outcomes: CTA’s for France, Germany, Spain, UK Pilot schemes for CTR and countries participating: Summary

Day1 outcomes: CTA’s for France, Germany, Spain, UK Documents required for submissions : (Core) EudraCT form, Protocol, IB, IMPD plus GMPcert/CoA/Import License/GMO approval (for EC: informed consent/insurance/Investigators info…) • Timelines for CTA preparation: start 6 months in advance (sooner in case of GMO); NCA documentation can follow strict planning; EC-submissions require more flexible planning (contracts etc.) • Choice of comparator(s)/Placebo ; placebo in oncology often considered unethical; use eg sunitinib or sorafenib in superiority or non-inf. trial pending proposed indication/target population • Target population, duration of therapy and follow-up : adv/mRCC (first line) or adv/mRCC after failure of sunitinib or cytokine therapy (2 nd /3 rd line); 6-12 months trial with 1-2 yrs follow-up (trial; consider safety package). • Possible endpoints PFS often primary, secondary: OS, responder rates, PRO’s… • Regulatory processes for initiation and maintenance of a clinical trial in the countries chosen (e.g. CTA and EC in parallel, use of national vs. VHP) consider VHP/VHP+/Pilot (see next slide), pending sponsor strategy (FPI)/availability docs • Factors influencing choice of countries: Authority review times, recruitment issues due eg incidence; finding treatment-naïve patients (1 st line), Investigators, import licences, multi-language label, contracts, availability locally of comparators/Standard of Care, use of CROs, previous trial-experience , global supply possibilities


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