Clinical process
Protocol Development
All agents approved by the New Agents Committee (NAC) will require preparation of a clinical trial protocol that fully details the study including the patient population, dosing regime, primary and secondary endpoints, and other components as appropriate. A clinician identified by CDP who has relevant expertise and is willing to become the principal investigator on the study will develop the protocol with CDP. Ethical approval will be obtained from the MREC (ethics committee/IRB).
Preclinical Development
In some cases it is expected that agents will not be ready to enter the clinic straight away and will require additional preclinical work to be performed, e.g. toxicology studies, formulation and/or manufacture. This work may be undertaken through in-house facilities or contracted out where appropriate. The timeframe for starting the clinical trial will depend on what preclinical work is required and the outcome of these studies.
Regulatory Approval
Following preparation of the protocol and completion of any preclinical work an application for a Clinical Trials Authorisation (CTA) will be submitted to the MHRA (UK regulatory authority) for regulatory approval. The CTA will be prepared by CDP in consultation with the principal investigator and clinical trial site(s) will have been identified. The application will be prepared by CDP in consultation with the principal investigator and the company where appropriate.
Start Phase I/II Trial
The clinical trial will commence following approval by the MHRA and MREC. Cancer Research UK shall be Sponsor of the study and the trial managed through its Drug Development Office. If necessary, the company shall be provided with safety data during the course of the study.
Complete Phase I/II Trial
The clinical trial will be completed when the trial endpoints and objectives have been met, the last patient has come off study and completed their follow up, and clean data listings are available.
Trial Report
The final data set will be analysed on completion of the clinical trial and a summary trial report provided to the company for review. Full data listings will also be provided should the company decide to exercise its Option. If the company does not wish to exercise its Option the rights to the agent shall be transferred to CDP for further development and commercialisation.
