Research Question & Protocol Development

All clinical trials should be designed to answer an important and relevant research question that has not previously been answered. This may require an in-depth review of the existing published literature, review of trials registered on clinical trial registries, including ClinicalTrials.gov and ANZCTR, and involving consumers with lived experience in developing the research protocol.  See NHMRC’s Statement on Consumer and Community Involvement in Health and Medical Research noting the Statement is currently undergoing a review.  We also recommend reaching out to the MCRI Consumer Involvement team for further assistance involving consumers in your trial design.

It is also important to engage a statistician early in the trial planning process.  They have the expertise to assist with refining the research question, establishing the sample size and appropriate trial design.  See Clinical Epidemiology & Biostatistics (CEBU) for further information.

We also recommend reaching out to the Melbourne Children’s Trial Centre (MCTC) early to discuss your trial proposal.  MCTC provides advice, assistance and mentorship in all aspects of Investigator-initiated trials, including design and conduct.

The protocol is a key document that:

·           Provides the study background, relevance, methods and ethical considerations.  Also clarifies role of individuals, sponsors, and funders in trial design, conduct and reporting.

·           Provides the site team instructions on how to conduct the study.  A well-designed protocol will provide clear instructions that facilitate good quality research, protecting participant safety and generating quality data that supports answering the research question.

·           Provides important information used by Human Research Ethics Committees, Research Governance Office (RGO), MCRI Sponsorship Committee and regulatory bodies to establish if the study has been designed and is being conducted in accordance with the ethics approval, governance authorisation and relevant local/National/International requirements.

·           Facilitates external assessment of the trial validity by the research community.

·           Aids researchers re-using the data in future research projects when designing their research protocol and helps reduce research waste.

CRDO have two protocol templates for clinical trials, the choice of which to use depends on the type of intervention. 

For trials evaluating a medicine, biological or device intervention, use MCTC063 Template | Melbourne Children's clinical trial (drug or device intervention) protocol

For trials evaluating an intervention that is non-therapeutic, i.e. not a medicine, biological or a device, use MCTC059 Template | Melbourne Children's clinical trial (non-drug, non-biological, non-device intervention) protocol.  Examples of non-therapeutic interventions include but are not limited to: surgical or radiological procedures; diagnostics; nutritional measures; cognitive, behavioural and psychological interventions; supportive or preventive care; physical therapy interventions; digital and public health approaches; traditional or herbal measures; and screening processes.

If you are planning a study in which individuals are not assigned to an intervention according to a protocol, please see Observational and Negligible Risk Studies/Other Human Participant Research/Non-Trial Research for other protocol templates that may be suitable for your project.

At the same time you are writing your protocol, conduct a risk assessment focusing on trial activities essential to ensuring protection of the trial participants and reliability of the trial results.

This will ensure you build Quality by Design into your protocol. See Quality by Design & Risk Management for more information.