National Cancer Clinical Trials Registry Report

The Clinical Oncological Society of Australia (COSA) convened a meeting on 23rd February 2005, to: – Inform all key stakeholder groups of current developments towards establishing a National Cancer Clinical Trials Registry; – Consider issues involved in the development and maintenance of a registry; and, – Provide a consensus view to put to relevant authorities. Fifty-six stakeholders attended the meeting, representing health consumer organisations, patient advocacy groups, clinicians, academics, government and the pharmaceutical industry. Delegates reached consensus on all major issues.

The following overriding recommendations were unanimously supported by the delegates as crucial to the development and operation of a registry.1. The establishment of a National Cancer Clinical Trials Registry should be fully integrated with, or developed as, part of a broader National Clinical Trials Registry.2. The development of a National Cancer Clinical Trials Registry is a key priority for all stakeholders, including:- Patients, carers and other health consumers;- Health professionals, including cancer clinical trials co-operative groups and their affiliates;- The pharmaceutical industry and Medicines Australia;- Government, and other cancer control agencies; and,- Ethics committees.3. A Clinical Trials Registry is a public health facility, of potential value and importance to all Australians. As such, it should be owned by the people, and therefore managed and funded recurrently by their representative, the Federal Government.4. The Clinical Trials Registry needs to be overseen by a broad-based, high-level Board, availableto and responsive to the views of the public.5. To ensure sustainability the funding cycle for the Clinical Trials Registry needs to be greater than five years. Ten years is considered an appropriate initial funding term once the registry is satisfactorily established.6. Day-to-day management and maintenance of the Clinical Trials Registry should be vested in individuals/ groups with an established track-record in this field. Of the options discussed by a sub-group of delegates, the National Health and Medical Research Council (NHMRC) Clinical Trials Centre was considered the preferred choice.7. To ensure that all users’ needs are met, consultation with all stakeholders is vital during the development and existence of a Clinical Trials Registry.8. The Clinical Trials Registry needs to be comprehensive. All trials likely to inform standardclinical practice (other than exploratory trials) should be included. Institutional ethics committees are the linchpin to ensure comprehensiveness.9. In relation to exploratory trials (e.g. Phase 1, pharmacokinetics) further consultation and discussion is required to reach agreement about appropriate data elements relevant for inclusion in a registry.9.1. Cancer consumers have clearly expressed a need for Phase 1 cancer treatment trials to beincluded, as often these are viewed as a last chance of dealing with the disease. Howeverindustry is concerned that if mandatory Australian requirements for all Phase 1 trial details are inconsistent with international registry requirements and global industry decisions, there may be difficulties in placing Phase 1 studies in Australian sites.9.2. The debate on exploratory trials should not hold up the development of the registry.10. The Clinical Trials Registry should include the data elements specified by the International Committee of Medical Journal Editors and the World Health Organisation (WHO) as an acceptable minimum dataset. Operational processes should be developed to minimise redundancy and the possibility of data entry errors.11. The Clinical Trials Registry should be kept simple and precise. Links to associated sites should be included to enhance the value and utility of the registry (sponsor, investigator, consumer medicines information, general and cancer-specific information, overseas registries, dictionary of terms, etc) without burdening the registry itself with high-level detail.12. The process of data collection needs to be simple and precise. A single on-line form is suggested. Linkage to a common national ethics committee application form is recommended.13. Once the registry is established with a minimum dataset, COSA and its affiliates in cancer control could develop models for providing more comprehensive or detailed aspects, to streamlineprocesses and add value to the Clinical Trials Registry for its user groups.14. Access and availability of the register should be unrestricted. Optional information submittedvoluntarily by the investigator or sponsor can be specified as confidential.15. Tailoring dialogue and information to the needs of different stakeholders will be necessary to meet their needs. Cancer consumer organisations are willing to assist in this process.16. The Clinical Trials Registry needs to serve New Zealand users, who have almost identicalneeds to Australians. These recommendations were forwarded to the NHMRC on 1st March for consideration at a Council meeting 9-10 March. At the time of writing this report, we had not heard the outcomes of the Council meeting.For the complete report, please click here