The Ohio State University Comprehensive Cancer Center

Abstract:

Principal Investigator: 
Donn Curtis Young, PhD
Research Scientist
The Ohio State University
James Cancer Hospital and Solove Research Institute

(Recommended for funding excluding the consent form translation part of the application.)

Early phase VII clinical trials are the primary clinical intellectual 'capital' of Cancer Centers in providing clear evidence of the translation of basic research findings from the laboratory to the bedside. At The Ohio State University Comprehensive Cancer Center, 74% of all patients participating in therapeutic trials are registered on early phase trials. Nevertheless, barriers to the enrollment of patients on early phase trials hampers the evaluation of new agents and delays the adoption of new agents and regimens. We will address three barriers to the enrollment of patients on early phase trials:

Barrier 1: The inability to conduct and document screening of patients for eligibility for enrollment on clinical trials in a comprehensive and efficient manner. To overcome the complexity of determining eligibility for any of our 130+ active phase I/II clinical trials we will develop and implement a computerized eligibility checking system integrated with our existing clinical trials SQL database using a rules-based application providing results to clinical trials staff using wireless tablet computers and wireless Palm devices.

Barrier 2: The difficulty in enrolling patients from minority and underserved populations. To address the underrepresentation of minorities on early phase trials, we will develop educational programs addressing phase VII trials to target minority physicians, minority nurses, and the urban community. These multimedia programs will focus on increasing awareness of recent innovations in early phase trials that replace guesswork and serendipity with rationally designed agents addressing molecular targets. Designated Minority Recruitment Coordinators will insure that all minority patients are screened for potential clinical trial participation. 

Barrier 3: The inability to provide full informed consent to patients unable to understand English, with limited English proficiency, illiterate, or visually impaired. The 21 million Americans who speak English "less than well" are often denied the opportunity to participate in clinical trials due to the inability to provide informed consent.

This project incorporates:

1)    An educational program to train interpreters in clinical research, the protection of human subjects from research risks, and their role in this process;

2)    Consent using an OPRR Short Form consent document;

3)    Oral translation of the English language consent form; and

4)    Videotaping the process with a copy being given to the patient for their reference.