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10 Steps to Clinical Study Startup: Step 4 - Conduct Feasibility

by Jae Chung
29Jan2018

Sponsors need to assess whether sites have the required facilities and knowledgeable staff to successfully enroll patients and produce high-quality data for a clinical trial.

10 Steps to Clinical Study Startup: Step 4 - Conduct Feasibility

Sponsors need to assess whether sites have the required facilities and knowledgeable staff to successfully enroll patients and produce high-quality data for a clinical trial. A standard practice for the sponsor is to utilize the Site Feasibility Questionnaire (SFQ) to gain an initial assessment of individual investigative sites' interest in, ability, and capability to conduct their trial. This document is circulated with far more sites than are required by the protocol, this extended reach into a larger number of sites is necessary since not all sites will be able or want to be part of the study. The SFQ is almost always used after the initial contact with potential sites for new clinical trials. Initial contact can be made through medical directors, medical or scientific liaisons, and the clinical research associate (CRA) at existing sites.

Veronica Ludensky
VERONICA LUDENSKY
Senior Manager, Clinical Outsourcing Management
Takeda Pharmaceuticals
"One critical aspect for an assessment of feasibility is the signing of a confidential disclosure agreement (CDA). If comments are required, a single set of consolidated comments with a clear understanding of the terms that are flexible and those that are deal breakers for either party is required. This distinction minimizes back-and-forth communications and streamlines the selection process."

The content of the SFQ is highly variable and dependent on the complexity of the protocol and the type of patient population. It is important for this questionnaire to be sent in conjunction with a brief study synopsis. Depending on the content of the synopsis and the sponsor's business policies a CDA may need to be collected. This intermediary step may increase the timelines as you wait for the CDA to be signed and collected.

Common roadblocks when managing SFQs

Assuming the initial short list of investigative sites targeted enough sites to fill the criteria for the protocol, one of the first challenges the study team will face is in the above-mentioned tracking process.

Sponsors encounter a few issues that consistently add to the timeline of the SFQ step and require additional follow-up. Often they simply receive incomplete questionnaires; they do not receive a response by the deadline, which is normally within 48 hours of receipt of the SFQ; or they receive inaccurate data.

Christine Pierre
CHRISTINE PIERRE
President
The Society for Clinical Research Sites (SCRS)
"Open sharing of information about study execution and operation is essential for the alignment of goals necessary for sites to achieve. A feasibility process that keeps sites in the dark is never going to reach our collective objectives."

Common reasons that the SFQ is late include: immediate lack of proper personnel to answer SFQ and a backlog of SFQs at the site. Sites often receive an inordinate number of SFQs, many of which pertain to studies inappropriate for their site, because of poor early identification techniques.

When sponsors receive inaccurate data, quite often this is due to sites simply not having enough information to adequately address the questions. A common ramification is that questions on the SFQ may go unanswered, which requires additional follow-up. Also, it is common for the SFQ to ask for estimations in which case the site struggles with how to estimate—high or low, which does not allow for the accuracy needed to understand the sites ability conduct the study based on recruitment and timelines.

Tips to handle SFQs

Most sponsors email Word documents or PDFs of the SFQ. Still other companies utilize online survey services, such as SurveyMonkey, or their own homegrown distribution and tracking tools. The person tasked with this process inevitably will need to be adapt at shifting between hard copies, electronic copies, their email application, and some lengthy and cumbersome spreadsheets to track the receipt of SFQs and manually input data obtained from SFQs received.

As is the case with many steps in the clinical trial process, greater transparency and technological advancements can help bring much needed efficiencies in the process of managing the SFQ.

10 Steps in Clinical Study Startup

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