It is critical to undertake a feasibility assessment prior to electing to participate in a clinical trial. you must be certain that the clinical trial is right for your site and your patient cohort. It is important to assess whether you can conduct the trial successfully at your site within the scope of the protocol and negotiate an appropriate budget with the Sponsor.

A robust assessment of your site’s capabilities is essential prior to agreeing to participate in any clinical trial. Feasibility factors to consider include:

• Scientific and regulatory issues
  • Does this clinical trial serve the interests of your patient population?
  • Is the trial scientifically and ethically sound?
  • Is the trial question clinically important?
  • Do you anticipate any governance review related issues with this protocol?
• Strategic fit with your organisation
  • Is your organisation participating in any studies that compete for the same patient population?
  • Do you have your employer’s approval to participate in the trial and conduct it from the site?
  • Does it align with the organisations service plan, mission, vision and philosophy?
• Staffing
  • Do you and your staff have the necessary and appropriate experience and qualifications?
  • Do you have an adequate number of staff with enough time to undertake the clinical trial properly and safely?
• Patient population/ recruitment
  • Can recruitment targets be met from the available patient population?
  • Are there any barriers to achieving target patient recruitment?
    • Current treatment options
    • Inclusion/ exclusion criteria
    • Competitive recruitment
    • Competing studies
  • What is the impact of the clinical trial on the existing treatment pathways for this patient population?
  • Will your trial have adequate representation from regional, rural and remote populations?
  • Can you collaborate with clinicians from regional, rural and remote communities to recruit participants by using teletrial model?
• Time
  • What are the Sponsor’s proposed start-up timelines?
  • Has the trial commenced elsewhere and your site is being asked to start later;
    i.e are you a “rescue site”? (NB this is usually never a good sign for a trial)
  • Is there adequate time to conduct the trial before it is projected to close?
• Facilities
  • Do you have access to the necessary facilities, equipment and health service resources, such as supporting departments and beds?
    • Has the facility operator (e.g. HNELHD, UON, HMRI) approved use of their resources for clinical trials?
    • Is an Access Request Review required?
  • Can supporting departments manage all the protocol specified requirements and extra workload?

WHO CAN HELP?

• Will your clinical trial need access to patients, staff or facilities? If yes, then you should liaise with the relevant supporting department/s and your Research Office
  • Calvary Mater Newcastle Research Office
  • Central Coast Local Health District Research Office
  • Hunter New England Local Health District Research Office
  • Mid North Coast Research and Knowledge Translation Unit
• Will your clinical trial need University of Newcastle governance approval, facilities or services (e.g. grant administration)? If yes, then you should liaise with your university research Office
  • University of Newcastle Research Office
  • University of New England Research Office
• If you need help costing and negotiating a budget the HMRI Clinical Trials Unit can support you with this. If you require support, consider building service and support costs into your study budget so that you can pay for this support.