Case Studies

Contact Gregg Sweet, MBA, VP Strategy and Development, at 919-388-3966 or gregg.sweet@icts.us

ICTS Connections: MAKING A DIFFERENCE

Typical Approach

Enable treatment and triage teams to refer, dynamic communication program 86% reduction in cost per

patient and 92% reduction in randomization time

In-service training, grand rounds,

hospital posters, PI responsibility

Acute In-Hospital Study

Case Study 1: Acute In-Hospital Study

•  Rescue, First Patient in 18 months prior, Pivotal study •  Fewer than 10% of patients randomized of 186 required •  Publication Date Scheduled 9 months out •  Referral Chain unaware of study •  In-trial processes not being followed properly •  Mostly University Hospitals with local IRBs •  Cost per randomized patient was > $15,000

•  ICTS Solutions •  Identification of all involved and responsibilities from diagnosis to patient exit •  Education of triage to treatment chain •  Modular format DVD Education program (10 chapters) •  Distribution to Investigators and the triage to treatment chain •  Study relevant thank-you gift for viewing DVD (increase viewership) •  Involve Primary Investigator and Primary Neuroradiologist in DVD

•  Cost: $347,000 •  Cost per Randomized Patient ICTS: $2,065 •  Randomization completed 45 days after distribution, article published on time

ICTS Connections: MAKING A DIFFERENCE

Typical Approach

Interactive presentation of Informed Consent to address all

patient concerns and enable better communication with SC

and PI 84% reduction in cost per patient, sustained 25% consent rate, 50%

increase in patient retention

Patient Lost at Consent

Each coordinator delivers consent, up to 45% mailed to prospective patients, standard script but no standardization

of delivery

Case Study 2: Informed Consent

•  Rheumatology, 1 ongoing study, 1 new parallel study •  Current consent rate at 7% and cost of randomized patient at $1,950 •  Very difficult I/E criteria •  Educated patient population •  Poly Pharmacy situation with many qualified candidates, requiring wash-out and

discontinuation •  Many coordinators mailing ICF to patients, not seen in person, as SOP •  Treatment working – consent rate low

•  ICTS Solutions •  Educational DVD, Modular Format, ICF Companion •  Standardize delivery to include information about FMS and the IC process and

patient communication •  Study team participation to increase credibility and decrease cost •  Professional Host to deliver bulk of message

•  Cost: $228,000 •  Cost per randomized patient: $814 New Study: $316 •  Consent rate increase to 20%, New study maintained a 25% rate

ICTS Connections: MAKING A DIFFERENCE

Typical Approach

Assistant Study Coordinators placed in site to manually review charts

73% reduction in randomization time, peer-to-peer site feedback enabled more secure client-site relationship

Building Site Relationships: Patient Identification

Archival Chart Review process left up to site

study coordinator

•  Cardiology study with very specific inclusion/exclusion criteria •  Large cardiology practices with large patient databases •  Too time consuming for regular study coordinator •  Varied EMR and paper records •  No EMR off-site review process available (no EMR consistency)

•  ICTS Solutions •  Assistant study coordinator placed in site •  Site pulled charts based on ICD-9 codes, age, treatment dates •  ASC manually reviewed electronic and paper records, labs, nuclear medicine

reports •  Patients who met criteria were referred to site study coordinator scheduled for

screening •  Average of 73% reduction in randomization time across all sites •  Peer-to-peer site feedback resulted in higher quality data

Case Study 3:

Assistant Study Coordinator

ICTS Connections: MAKING A DIFFERENCE

Typical Approach

Centralized recruitment advertising, integration of all

efforts, enhanced site communication

86% reduction in randomization time, 1612 subjects randomized in 8 weeks,

sites remained motivated

Recruitment sole responsibility of sites, small

advertising stipend

Accelerated Recruitment, Large Recruitment Goal

•  Depression/Anxiety combined study with 6 treatment arms •  148 sites in US and Canada •  1,600 patient randomization goal •  Varied SC experience levels •  Plan began at investigator meeting

•  ICTS Solutions •  Recruitment roll-out at investigator meeting •  Study coordinator patient recruitment training at investigator meeting •  Enrollment toolkits provided to study coordinators •  12 week, integrated advertising and patient communication program

•  Local site advertising (from stipend) •  Centralized advertising •  Call screening, referral and site follow-up

•  Bi-weekly SC teleconferences (5 regions) •  Comprehensive patient tracking

•  1612 patients randomized in 8 weeks •  60% of sites met enrollment goals

Case Study 4: Integrated, Centralized Recruitment

For more information contact:

Gregg Sweet, MBA VP Strategy and Development

o. (919) 388-3966 c. (919) 523-3717 f. (919) 324-3501

www.icts.us Gregg.Sweet@ICTS.us