10 Steps to Clinical Study Startup: Step 5 – The Pre-Study Visit (PSV)

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10 Steps to Clinical Study Startup: Step 5 – The Pre-Study Visit (PSV)

Step 5: This is the fifth 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

There has been a lot of discussion about the topic of the pre-study visit over the years. Much of this discussion has come about due to a possible disconnect between sponsor or CRO objectives and expectations when compared to those of the research site.

It remains the case that in order for a sponsor or CRO to find the number of research sites they need for a given protocol, they must engage in discussions with sites with which they have no previous experience. And it remains the case that there is no other way to collect information about potential sites than to initially rely on the site’s own, self-reported metrics and information.

This necessitates that the sponsor or CRO will inevitably perform what is called the pre-study visit (PSV). If there is some previous experience with the site in question this visit may be foregone in favor of a pre-study phone call.

Some objectives (sponsor/CRO) of the PSV are:

• Validate site claims made on SFQ and in previous discussions during site ID
• Evaluate condition of site
• Review essential study documents

o Protocol
o Source Docs
o ICF

• Review patient recruitment strategies
• Review advertising campaigns
• Provide training
• Special set-up
• Meet PI to gain comfort regarding his/her ability and interest for the protocol

The PSV is oftentimes viewed as a necessary evil by the site. This is mostly due to the inconvenience in hosting a study monitor for what is often a full day (can be longer). This inconvenience translates to the site, a real expense in terms of resources required to adequately prepare for and conduct the PSV; resources which typically are not reimbursed. It is considered a cost of doing business. However, the PSV also is an excellent opportunity for a site to make a good impression and get off on the right foot with their sponsor and CRO customer.

Tips for a successful PSV:

- Be prepared!

* This goes for the site as well as the sponsor/CRO. It is not uncommon for sites to receive multiple calls rescheduling the PSV. Common complaints from sites include hosting ill-prepared monitors. Likewise, common complaints from sponsors/CROs, include lack of adequate preparation by site staff, including PIs.

- Be professional!

* This may seem elementary, but unfortunately, it is common for this concept to be lost on individuals when conducting PSVs. All parties from both sides should not have a mindset of this being an adversarial event; rather an approach that both parties are entering into a professional relationship of mutual benefit and interest.

* The site should be prepared to host this meeting, keeping in mind the responsibilities of any good host: make the environment comfortable and welcoming, accommodate, prepare, and maintain a pleasant and professional demeanor. Likewise, the company and person making the visit should do all in their power to take in consideration the inconvenience to the site and the resources they must expend to make it a successful meeting.

- Take advantage of face-to-face time to build a stronger business relationship.

* Often, this is the first meeting between a company as well as probably the individual with whom the site will work if they are chosen to participate in the trial. Keep in mind that the vast majority of sites hosting a PSV will be selected and activated on the study. Sponsors and CROs do not take the decision to spend their resources on PSVs lightly. From a business development angle, this meeting is an opportunity to make an excellent first impression; which will pay dividends in future business with the sponsor and CRO. This is a site and PI’s opportunity to show ability, expertise, and most of all, interest in the particular protocol. Conduct at a PSV will often set the stage for relationship management throughout the completion of the protocol in question. If it starts well, often that is the overall impression throughout the trial; likewise, if it begins with conflict – conflict can be predicted throughout.

A final and very biased opinion of this author on PSVs: strong consideration should be made by the collective participants in this industry (sites, sponsors, and CROs) to provide a monetary reimbursement to sites for PSVs. Something reasonable and more than nominal should be provided to the site/PI for this activity. It is common for study budgets to include line items such as non-refundable start-up fees, but it is also common for these fees not to be itemized and thus they fall short of providing comprehensive coverage for site start-up costs. I feel safe in voicing this opinion because there are far more PIs and sites in the world than sponsors and CROs, so I believe I am arguing for the “majority” and most readers will agree.

About the authors:

Allan Valmonte is a 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 Senior Director of Business Development at goBalto and 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