Study Feasibility and Start-up Tiffany Morrison, MS, CCRP Director, Clinical Trials Rothman Institute

Learning Objectives Outline a few examples of things that are necessary to consider when you’re assessing study feasibility at your site Explain why it is necessary to sign a CDA prior to initiating contact with the Sponsor of a study

Startup Activities: Image courtesy of CITI Program Clinical Research Coordinator course

Interest Letters/Feasibility Questionnaires What are they? What do you do with them?

Interest Letters / Feasibility Questionnaires Inquiry from a Sponsor or CRO (Contract Research Organization) to ascertain if there is interest and the ability to participate as a site in a clinical trial Come in many forms with varying amounts of information Usually include a Site Selection and Feasibility Questionnaire Completed by the Investigator and/or the CRC Good practice to notify the Business Manager if interested http://www.dfhcc.harvard.edu/research/clinical-research-support/crs-search-results/?tx_hcc_search%5Bquery%5D=feasibility+ May come via email or snail mail. May include a protocol synopsis or general information regarding the study. This is the Sponsor’s opportunity to evaluate the Investigator, the Site and Resources to see if they can be successful in enrolling patients and completing the protocol as written. Also the Site’s opportunity to sell themselves as a desirable site. See hyperlink for good example. (Also saved to desktop…hopefully!)

Interest Letters / Feasibility Questionnaires Sponsor Interested Investigator Interested Sponsor contacts the Investigator and coordinator listed in Feasibility Questionnaire Sponsor sends CDA (Confidentiality Disclosure Agreement) and sets up a Site Selection Visit

Confidentiality Disclosure Agreement: CDA Written agreement ensuring that investigators and/or staff do not disclose the contents of the protocol or proprietary information regarding the study. A legal document Needs to be reviewed by ORA / JCRI Business Operations prior to returning to Sponsor (or sending out in the case of IIT) Mention Ron Polizzi will be presenting to follow

How to Read a Protocol (Quickly!) Title Table of Contents Protocol Synopsis: Number of Centers (U.S. or worldwide?) Number of subjects Target population Objectives Treatment plan/duration Inclusion/Exclusion Tables: Study Schema Study Events Table (read the superscript!)

Study Events Table Example

Study Schema Example

Assessing Protocol Feasibility The ability to enroll patients is paramount to success! Adequate patient population? Competing protocols? Resources required to execute protocol activities available? What information will be collected and how? Additional training, space or equipment required? Adequate availability of time; PI and CRC? Opportunity for scientific publication or authorship? Possibility of strengthened collaborations with sponsor for future studies? Cost to conduct study versus proposed funding (if any)? This is the PI or Site assessing the ability to get the study done and if it meets their needs. If so, then fill out sponsor feasibility questionnaire and return. This is very different than evaluating and negotiating the budget.

Assessing Protocol Feasibility Is it necessary to collaborate with other departments for this protocol? Microbiology: send protocol and make sure they’re able to perform all necessary testing Investigational Drug Service: very important to bring IDS into this process as early as possible IDS will determine if they’re able to prepare drug according to protocol and will help work through logistics Radiology: MRI protocols, scanning protocols are often specific. Need to make sure we’re capable of completing the radiological section of the protocol

Site Selection Visit Aka Pre-Selection Visit (PSV) Not to be confused with a Site Initiation Visit (SIV) Sponsor will visit site to confirm facilities and staff are adequate to perform protocol Will review the protocol, discuss any potential obstacles, and confirm commitment Sponsor may collect some regulatory documents (Investigators CV and license, lab certificates, etc.) Make sure you schedule time with additional Departments, as necessary

Next Steps! Clinical Research Pre-Award Process IRB Submission and JCRI Business Operations Submission are Parallel Processes Approved Application IRB Contract Budget Approval Letter Approved Approved