Thinking About Site Startup

I've been thinking a lot lately about how important it is to choose the right clinical trial sites for the success of your trial.  Just last week I blogged about the painful process and high costs of closing non-performing or under-performing sites.  I recently told a non-industry friend that it can take upwards of 18 months sometimes to usher a clinical site from selection to initiation.  He responded, "well that make sense since many clinical trials last several years and it takes a while to give the medication to enough patients to test it out thoroughly."  Then I realized he had misunderstood me, I clarified, "Initiation means the doors are open. At initiation, a doctor can start looking for patients.  I am telling you that it can take one year or more sometimes just to get a site open for recruitment to start the trial."  He was floored and responded, "no wonder we're paying so much for our prescriptions..."

I recently went to an ACRP seminar called 'Why Sites Fail in Study Startup'.  The dynamic speaker, Christine Pierre is the President of RxTrials Institute (RxTi) and gave a terrific talk.  If you would like to meet her or discuss this topic further, perhaps you would like to attend the Site Solutions Summit in October.  I haven't booked my travel yet but I am definitely considering going.

Early bird rates are available now!

I am excited to see the next-generatiion startup
tracker product when it is released. 

Then, a few days ago I traveled to downtown San Francisco, CA to visit the offices of goBalto. This innovative company has developed a web-based platform for Clinical Study Startup, Tracker™. The software "enables clinical trials sponsors to collaborate with multiple partners directly from the web in a transparent and regulatory compliant manner".  They invited me to a demo of their next generation product to participate in a user feedback session.  I was really impressed and found them to be extremely forward-thinking.  I am excited to see the product when it is released.

So, all of this has led me to develop a new series for the blog focusing on: Site Startup.  In addition to my work as a Lead CRA, I have been involved in clinical study site startup for a variety of pharmaceutical companies pretty much without interruption for the past 28 months.  Whoa, over 2 years you say?  "Surely, Nadia you must have tremendous experience launching study sites for many clinical trials in that time!"  Yeah, well uh, regrettably, no.  However, in that time I have worked with six disparate clinical operations teams and supported the process of opening a few hundred sites in five different countries (mostly Phase II trial sites).

As a regional monitor at a CRO, I would routinely assist with pre-study site selection visits and administration of feasibility questionnaires but the majority of my work was 85% regional monitoring and site management once sites were open.  Since I have moved to an in-house role, I spend a lot more time in the start-up side of things, buried in spreadsheets, trackers, dashboards, and demands from my boss and the board of directors, so I have gleaned some valuable insights. We'll be stepping through several broad topics of site startup in the coming weeks including:

• What are the typical milestones of site startup?
• What is feasibility? How do sponsors choose which clinical trial sites they work with?
• What is an essential document package and a regulatory submission?
• Informed Consent Form templates
• Site Budgets
• Why do contracts take so long? How are they complicated?
• Developing Investigative Site Patient Recruitment Plans
• IRB submissions
• Calculating Investigational Product needs
• Providing study supplies and source documents
• Ensuring sites are adequately trained and prepared to participate
• What correspondence goes in the Trial Master File?
• Metrics, trackers, reports, and dashboards 
• Gating tasks...bottlenecks
• Lessons learned, where did the process breakdown?
• How to speed up site startup?

What is missing from this list? Do you have other questions or topics that you would like me to cover related to site startup? Please leave me a comment or drop me an email at leadcra-mail@yahoo.com.