The process of clinical trial design is a crucial and important step culminating in development of a clinical trial protocol. Different designs suit different questions, different scenarios. Your research hypothesis informs the aims of the trial, which in turn inform the outcomes of interest, and in turn the endpoints of the trial that you can measure, that let you test your hypothesis. You might also think about if it is useful to conduct a pilot study to test the feasibility of the research question.

Who can help?

• HNELHD Nursing and Midwifery Research Centre offer a consultation service in research design
• The HMRI Clinical Trials Unit (CTU) can also provide advice and support during clinical trial design. If you think you might require support, consider building service costs into your study budget so that you can pay for this support.
• HMRI Biostatistics Team offer brief (10-15 minute) free consultations every second Tuesday in the HMRI cafeteria from 1.30 pm – 2.30 pm. A more comprehensive consultation and quote can be requested here.
• Your Health Consumer Representative can provide a participant’s perspective on the feasibility of your clinical trial design. This could significantly improve your recruitment and retention success rates.
• Trial Forge in the UK has developed tools to include a diverse range of people in clinical trials, including ethnic communities, those living with socioeconomical disadvantage and those with impaired capacity to consent.
• Trial Forge also has trauma and resilience informed principles for clinical trials.