"Conducting Clinical Trials A-Z"

Why consider being a clinical trial investigator?

Clinical trials are defined as any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharmacodynamic effects of an investigational product with the object of determining safety and/or efficacy. It is through these trials that investigational drugs, devices, and diagnostics may show their benefits.

Clinical trials have several layers of protection for human subjects including Institutional Review Board (IRB) approval and monitoring, data safety monitoring boards (DSMB) that review the data while a clinical trial is in progress to ensure that participants are not exposed to undue risk and careful monitoring and attention from the investigator and staff.

Being involved in clinical trials can be a positive experience offering an opportunity to learn, become exposed to new medical therapies and provide additional options or alternative treatments for your patient population.

• Explore New Treatments and/or expense support for Patients
• Publications
• Revenue support
• Opportunity for PI and trainees to learn and expand skills
• Gain experience and credentials that could lead to grant funding and investigator initiated ventures

What do you need to conduct trials?

Developing a quality clinical trial site is a process that is on-going as sites grow in experience and develop “best practices”.  There are minimum needs to consider when getting started illustrated by the acrostic phrase, SPORTS TEAMS.  Fortunately there are many institutional resources available to assist you in the process.  The mission of the UK Clinical Research Organization (UKCRO) is to provide clinical/translational research faculty and staff with the infrastructure and operations support to facilitate access to outstanding clinical research trials to the citizens of Kentucky.

Space/facilities (available from UKCRO)
PI (qualified and committed)
Organizational Support
Research Interest (clinically and financially feasible) 
Time
Staff (trained coordinator or UKCRO)

Training in mandated areas
Effort approved from department
Available subjects
Mentor or UKCRO
Sponsors (exposure to industry or grant funding)

The remainder of this manual will provide details on these areas and further describe not only the requirements, but the resources available to UK investigators.