10 Steps to Clinical Study Startup: Step 1 - How to identify qualified sites
- September 16, 2010
Partnerships In Clinical Trials 2011 Media Partner Go Balto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!
This is the first 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
The first key activity for sponsors when starting up a clinical study is identifying potential investigative sites. Recruiting quality investigators and investigative sites is critical to the overall endgame for a sponsor because this activity directly correlates to quick subject enrollment, high-quality data and subject retention for any clinical study. Most describe this important activity as labor intensive and time-consuming.
We’ve outlined 4 common methods below that Sponsors use to identify investigative sites and commented upon their effectiveness along with some drawbacks.
1. Internal Databases
It’s no surprise that sponsors already have internal databases of sites that they’ve worked with in the past. The advantages of utilizing an internal database are that it is readily accessible and is pre-populated with sites that the sponsor has worked with before. An internal database helps sponsors maintain relationships with sites that have performed well in the past. Since quality sites are difficult to find, maintaining an internal database helps sponsors cultivate long-term relationships with sites they would like to use for future studies.
One major drawback is that the sponsor needs to actively maintain the database. Sponsors have to manually enter new data and track any changes to the database, which gets even more labor intensive as the database becomes larger. While an internal database provides a great starting point for established sponsors, the data is limited and sponsors often need to expand their list of investigative sites for a new clinical study. Internal databases are generally not comprehensive enough to support larger studies and often don’t reflect current data. We are also observing a trend towards an increasing number of sites located in emerging regions, making it harder to gain transparency on who’s good or bad. According to a recent Center Watch study, more 25% of investigators are “first timers” – juggling their own practice, resulting in high turnover is high and poor performance. Staying up to date on qualified investigators is challenging.
2. Contact your friendly neighborhood CRO or SMO
Engaging a Clinical Research Organization (“CRO”) or (“SMO”) as a development partner is a common industry practice for sponsors when starting up clinical studies. CROs can provide a wide range of services to sponsors including site identification as part of the study startup process. CROs that provide site selection services also provide their own list of investigative sites. While several CROs help identify sites, there is an important distinction to consider when evaluating which CRO to partner with. Larger CROs generally have a wide-breadth of expertise and capabilities to handle multiple indications. These larger CROs may be able to service the sponsor, however their list of sites may be out of date since they’re spread across multiple indications. Smaller, niche CROs will more than likely have a more focused and up-to-date list. However, since smaller CROs are niche providers, many of their sites may already be dedicated to other competing studies.
3. Word of mouth
Another effective means of finding sites is identifying a key opinion leader (KOL) in a particular indication. Generally, KOLs are professionals with firsthand knowledge and experience working in a particular indication, whom can be found by scouring scientific publications. Something worth considering when engaging a KOL as an investigative site – just because they’re a KOL doesn’t necessarily mean that they’re a high performing site.
Other investigative sites are also a good resource to tap when needing to identify new sites. Most sites that we’ve come across have acknowledged that they are willing to refer other sites to a sponsor that can accommodate a clinical study.
4. Directories
Sponsors utilize both online and offline directories to identify sites and cast a wide net for site feasibility. Some online directories allow sponsors to search for sites free of charge, while others require a fee. Directories can be large and help sponsors broaden their list of sites, however the drawback is that it’s still difficult to judge the quality of the sites in the directory. Plus, website administrators maintain static directories, therefore Sponsors don’t always get the most current data. While online and offline directories can help sponsors quickly generate a short list of potential investigative sites, sponsors will need to spend more time researching the quality of each new site, a labor intensive and time consuming process. We’ve reviewed some of the online directories sponsors use. You can see read the reviews here.
Closing Thoughts
The methods listed above are by no means comprehensive, but are simply the most common tools we’ve found that sponsors use to identify investigative sites. Sponsors often use a combination of these methods to quickly find the right ones for their clinical study. Identifying sites is one small piece of clinical study startup, and sponsors who invest the time and effort into doing it right will save time and money further down the road.
About the Authors:
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.
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