"Conducting Clinical Trials A-Z"

How do you garner industry trials?                 

UKCRO Marketing - Providing a link between industry and academics

The UKCRO serves as a liaison between clinical trial sponsors and research faculty.  We are a resource for sponsors in identifying investigators to conduct trials and assist faculty in searching for trial opportunities in their preferred therapeutic area.  UKCRO marketing activities include:

•       maintaining a research interest database of over 452
  researchers with interests in a variety of specialty areas, including Ph.D. researchers for translational opportunities.

•       maintaining a database of all opportunities that are either initiated by the UKCRO, an investigator/staff or by a sponsor.  

•       maintaining a promotional profile on the CenterWatch which is a premier website that is used by sponsors and CROs to select  study sites.

•       exhibit at one national meeting to promote UK and expand network of sponsor contacts

•       subscribe to various print and electronic resources, (pipelines), for identifying new and upcoming trials or investigational products

•       run searches upon request for trials in specific therapeutic areas

Gaining experience:

One of the criteria sponsors use to place clinical trials is experience with conducting clinical trials, which makes getting the initial trial a challenge.  Many investigators recommend working with an experienced PI as a sub-investigator to learn the process and make them more prepared and credible to sponsors. In addition the UKCRO can offer the novice investigator guidance and provide a variety of services to conduct a trial.  Getting the first trial is a huge accomplishment; however attracting repeat business is best accomplished by a job well done.  Quality remains the best marketing strategy    

Increasing visibility and exposure:

Communicating with industry sponsors may take place with the site responding to a sponsor query which usually consists of a study offer and site questionnaire, or the site can proactively contacting the sponsor or CRO by:

• sending literature, brochure or letter to sponsors OR
• requesting to be added to the sponsor or CRO’s investigator data base (often available on sponsor websites) 

Either way the information of interest will likely include:

Site specific information such as your credentials and board certifications, potential patient pool, research experience and publications, academic and staff appointments, specialized training, site personnel (dedicated or part-time, trained or certified coordinator), and clinical trial statistics (number trials, enrollment, retention).  In addition they will need information about the institution and region including patient demographics, geographic region, facility description, institutional policies, study start-up benchmarking time, resources, etc. 

TIP: Refer to the University of Kentucky Chandler Medical Center (UKCMC) Profile and the Site Selection & Pre-Study Visit section of this manual for answers to common sponsor questions.

Finding trials:

Investigators find trials and trials find investigators through a number of means. The following are suggestions from experienced investigators for identifying potential trial opportunities:

Network with pharmaceutical industry personnel who may have contacts with research and development divisions.

Circulate at national meetings and network with other investigator sites.

Develop handouts or tailor existing promotional brochures.

Search the industry pipeline or databases (see below).

Always follow-up on contacts to ensure you are in the potential pool of investigators, as the function of site selection can be delegated from the sponsor to a CRO or from one CRO to another.

PROFILE of UKCMC – also located on CenterWatch

The University of Kentucky Chandler Medical Center (UKCMC) is one the nation’s finest academic health care centers. The vision of the UKCMC is to be a Top-20 academic health center with national and international recognition for excellence in teaching, research and patient care.  The University of Kentucky is achieving outstanding success in the competitive arena of research grants & contracts.(see Research statistics and national rankings)  Major research areas include Aging, Behavioral Health, Cancer, Drug Evaluation, Infection and Immunity, Endocrinology, Gastroenterology, Surgery,  Neurosciences, Spinal Cord Injuries, and Women's Health. (view therapeutic areas)

Facilities

The University of Kentucky is centrally located in the scenic rolling hills of the Bluegrass.

(For descriptions, including photos, of some of UKCMC’s facilities, see Facilities).

The Lexington, Kentucky campus includes:

University of Kentucky Hospital, a 473-bed facility that admits approximately 20,000 patients annually, contains a 250,000-square-foot Critical Care Center, the UK Children’s Hospital and operates the area’s only Level I Trauma Center to treat critical injuries and burns.

Medical Center Colleges (College of Dentistry ; College of Medicine; College of Nursing ; College of Pharmacy ; College of Health Sciences ; and  Kentucky School of Public Health .

Kentucky Clinic facilities (Main, North and South), an ambulatory care center (see Kentucky Clinic).

UKCMC Rankings and Accomplishments

UK Clinical Research Organization Research Clinic (UKCRO) and the General Clinical Research Center (GCRC) occupy the newly remodeled Research Outpatient Clinic. Both facilities resources are available to all clinical investigators throughout the University.

The research clinic is conveniently located in the Kentucky Clinic, which is adjacent to the University of Kentucky Hospital, this 4000 square foot facility provides ample space to conduct outpatient trials and short-term pharmacokinetic studies.

Outpatient amenities include:

• Reception Area
• 7 exam rooms
• 2 capacity infusion room
• Lab processing and shipping area with dry ice
• 3 Individual Monitor Areas complete with remote computer hook-up
• Administrative Offices
• Conference Room
• Secured Storage
• Cold Kitchen
• EKG
• Access by bridge to the UK Hospital and Services
• -70° Freezer
• Emergency Cart Available
• Refrigerated Centrifuge

Inpatient amenities include:

• 14-bed inpatient unit
• GCRC Laboratory
• Metabolic Kitchen

General Clinical Research Center and inpatient research unit

Lexington Veterans Affairs Medical Center, (VAMC)
Many faculty members at UKCMC also maintain a joint appointment at the VAMC (107 acute care beds & ambulatory care center), expanding the potential research subject base.

Highlights

•       Institutional IRB meets six (6) times each month for rapid review and approval.

•       Numerous support centers to aid faculty engaged in clinical research

•       Clinical Research Administrator negotiates only clinical trial agreements.

•       Clinical Research Organization provides administrative, regulatory and/or operations support to investigators to accelerate study initiation and coordination.

•       4000 square foot outpatient research clinic and 14 bed inpatient research unit

•       Faculty & Staff with experience in IND initiation and maintenance

•       Study initiation averages 45 working days.

•       Dedicated inpatient and outpatient research facilities.

•       Faculty and staff with experience in Phase I, II, III and IV clinical trials.

•       Investigational Drug Service maintains a secure storage, dispensing and accountability system with service available 24 hours per day.

•       Category B device approval through UK managed care.