10 Steps to Clinical Study Startup: Step 4 – Sending, Tracking, and Evaluating SFQs

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10 Steps to Clinical Study Startup: Step 4 – Sending, Tracking, and Evaluating SFQs

This is the fourth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

Introduction

It is standard practice for the sponsor or CRO to utilize the Site Feasibility Questionnaire (SFQ) to gain an initial assessment of the individual investigative site’s interest in and ability to work on their trial. This document will be circulated with far more sites than are required by the protocol. This really begs the question of how accurately these sites are targeted in the first place, but that is a different subject.

The only constant in this document is that it is almost always used to make an initial contact with potential sites for new clinical trials. Its content is highly variable and it can be a half page to more than 10 pages in length. It is common for this questionnaire to be sent in conjunction with a brief study synopsis. Unfortunately, at this point, without a CDA in place, the synopsis and questionnaire must necessarily be brief and vague. This will take its toll in the form of time-hungry follow up required later on when the Study Manager is sorting through responses and contacting various potential sites regarding the next step in their selection process.

The next step, as you may have surmised, is often another questionnaire. An intermediary step may exist where the CDA is distributed, signed, and collected. This will achieve the privacy requirements necessary for the sponsor to share more of, or a complete protocol. The next questionnaire will be detailed and specific with regard to the protocol. Following the mayhem of the questionnaire flurry, usually a pre-study visit, or pre-selection visit (or phone call) is scheduled.

Common Roadblocks:

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

To add to the time-line and aggravation in this process it is common that study teams:

* Receive incomplete questionnaires, requiring additional follow up
* Receive no response by the deadline (It is common for sites to be asked to respond within 48 hours of receipt of the SFQ), requiring additional follow up
o A couple common reasons why the SFQ is late include:
+ Immediate lack of proper personnel to answer SFQ
+ Backlog of SFQs at sites. Often, because of poor early identification techniques, sites receive an inordinate number of SFQs, many of which pertain to studies inappropriate for their site.
* Receive inaccurate data*

*This problem merits further explanation. Sites are not intentionally trying to deceive the initiators of the SFQ; oftentimes they simply do not have enough information to adequately address the questions. A common ramification is that questions on the SFQ may go unanswered, which of course requires additional follow up. Also, it is common for the SFQ to ask for estimations in which case the site is plagued with the question – do I estimate high or low?

Summary & Tips

Not more than 3 years ago, it was common for the SFQ to be distributed through fax blasts. Now, of course, e-mailing Word documents or PDFs are popular options. Still other companies are utilizing web sites such as SurveyMonkey or their own internal distribution and tracking tools. Factors to keep in mind for this process are:

1) Establish effective tactics to pre-identify sites for receipt of the SFQ.

2) Employ efficient methods for the SFQ distribution.

3) Utilize simple, easy-to-use, tracking tools to help monitor SFQ activity.

4) Ideally, data from SFQs received would also be organized and sort-able, to help the study team in the qualification process.

5) This system would also help manage the responses to sites, helping to close the loop on this process.

Most often though, these high-efficiency, automated tools are not in place. The person tasked with this process inevitably will need to be adept at shifting between hard copies, electronic copies, their e-mail software, and some lengthy and cumbersome spreadsheet(s) 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.

Allan Valmonte is the Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward.

Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley.

Dan Manak is a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com