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Tuesday, January 8, 2013

Improved Investigator and Site Relationships - Part II

This is a presentation I gave at the 4th annual Outsourcing in Clinical Trials conference in San Francisco in February of 2012. It has been posted in three parts:

Click here to go back and review Part I 
Read Part II below
Part III - conclusion


Support the sites in order to maximize subject enrollment of THE RIGHT PATIENTS, quickly. 
Consider having the study medical monitor or other scientific/medical officers from your company travel and outreach to sites.  Identify conferences where many of your important sites are attending and send a representative to discuss and promote the study.

Educate the sites in the following areas:

How is the sponsor credentialed?
What is our experience in this therapeutic area
Who are our advisors (if well-known)
What other sites are we working with

Present Evidence 
• Demonstrated safety and efficacy
• Why are we doing this? 
• Explain issues in the Investigator Brochure (explain for clinicians technically and for non-clinicians in lay terms)

Why should PI share the resources and risk?
• What problem solved?
• How is this superior than other available therapies?
• Focus on objectives and endpoints of the trial

Translate protocol decisions

Explain reasoning behind inclusion and exclusion criteria
Defend design 
Explain sample size
Describe planned statistical analysis
How does this trial fit in the overall drug development program 

Communicate timelines
Share enrollment numbers 
Notify in advance of planned scientific advisory board meetings
Adequately notify data entry personnel of planned data cuts 
Are there planned interim posters and abstracts?

Remind study sites that even a study that fails to meet all endpoints is an important trial to your company.  Making go-no-go decisions on NDA candidates early is fiscally important.  The trial needs to be enrolled as soon as possible in order to finish as early as possible and permit analysis of the data.


Keep messaging tight, brief, and organized. Avoid complexity
What am I saying or adding with this? 
Before you put together a super verbose newsletter or another unnecessary blast fax, apply cuts and edits.  Make sure that every message is useful and comprehensive; balance the need to include all of the necessary information so you won't have to clarify later and there won't be ambiguity.

Same message, different method
Consider targeted messaging, some sites need different types of support depending on their experience and performance. 

Avoid “machine-gun” approach and make sure messaging is timely, appropriate, and not overwhelming.
Communicate with respect
Monitor to ensure that your interactions are not unwelcome.  In an effort to "keep in touch" with your sites you must treat carefully as to not barrage them.  Be wary of any investigative site that might have resent for your company's involvement.  The study site personnel do tend to interact across sites and you must always keep your reputation squeaky clean.  Also monitor for negative responses to avoid damage to the reputation you are working to build.

Avoid band-aid approach
Allow for different messaging methods for different sites and be willing to tailor messages.

Continue on to... Part III - conclusion

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