Get the support of a biostatistician
It is important to have support from a Biostatistician in the planning stage of the trial.
Key activities that require input from a Biostatistician
Many institutions have in-house Biostatisticians who can provide statistical support at no cost for researchers for a defined number of hours per project. It is important to consider that complex trial designs may require additional support and to consider this cost when working out the budget for the trial.
Partner with consumers
Important information that researchers can obtain when consumers are involved in the study design includes:
- Confirmation that the research question addresses the healthcare needs of patients
- Develop study assessments and visits that are practical/feasible for the participants
- Understanding the diversity of the target patient population and any barriers to trial participation that need to be addressed in to allow patients from different demographic locations and culturally diverse backgrounds to participate
- Develop information and resources (for example the participant information and consent form, brochures, fact sheets, social media posts) about the trial treatment and consent process that meet the needs of all potential participants, carers, families and consumers
- Easy to understand
- Provided in different languages
- Easy to use and provided in different formats
Partnering with consumers is one of the five components of the National Clinical Trials Governance Framework. This new framework will come into effect in 2021 and lists actions that a health service organisation must meet if it provides a clinical trial service.
Researchers should be familiar with and follow their institution’s policies and processes for partnering with consumers, or see the VCCC Consumer Engagement toolkit and resources.