Clinical research questions almost always require a team with diverse skills and expertise. An important step is to assemble a team with the right composition to help develop your research question into a robust clinical trial. Understanding your own personal research skills and attributes will help you build the right team with the necessary skills and expertise.

• Do you have a team with necessary skills and experience to undertake the clinical trial?
  • Who is the Sponsor of your clinical trial?
  • Who will be the Coordinating Principal Investigator?
  • Who will be the Principal Investigator?
  • Will there be Associate Investigators?
  • Who will be the Study Coordinator?
  • Will a Biostatistician provide the statistical design and analysis?
  • Are drugs or medicines part of your trial? Do you need a Clinical Trial Pharmacist?
  • Is a Data Manager required to manage data collection?
  • Do you have a dedicated Ethics and/or Governance Manager to manage the regulatory requirements?
  • How will Consumers guide development and conduct of the trial?
  • Do you have a Financial Manager in place to help ensure good fiscal management?
• Consider potential collaborators who can add value to your clinical trial?
  • Start conversations with others; the outcomes and activities may range in scale from simple discussions through to significant long-term partnerships
  • Consider if and when collaborations should be agreed and documented in a formal agreement. Formal agreements may include confidentiality and non-disclosure agreements or a Memorandum of Understanding.
  • Are you able to collaborate with other clinicians in your broader community so you can include participants in rural, regional and remote communities?
  • You may also consider providing opportunities to build future research capacity by engaging with and mentoring interested co-workers, researchers and research students.
  • Can your clinical trial provide deeper value to patients and the healthcare system by exploring other facets of the question at hand? For example, would a health economic analysis of the trial help with future implementation? Are there fundamental biology questions that your clinical trial could help answer – do you need to engage with basic scientists, or collect biospecimens through a biobank?
  • Can you add value to your clinical trial by examining the health-related quality of life or elements of the patient experience, who people in your clinical trial interact with the healthcare system?