All content copyright, Creative Commons Attribution-Noncommercial-Share Alike 3.0
Unported, with the attribution: "The Lead CRA Blog", and a link to the post.

Tuesday, January 8, 2013

Striving for Improved Investigator and Site Relationships

Last year I was invited to present at a conference in San Francisco; it was a wonderful experience. Here are this year's conference details.

5th annual Outsourcing in Clinical Trials West Coast

I was just organizing some files on my computer and came across the slidedeck, "Striving for improved Investigator and site relationships to achieve higher commitment and optimal patient numbers" that I created for my topic in 2012.  Since I never got around to sharing it with you all last year (except for those of you that provided notes and edits - thanks again!!!), please enjoy and let me know if you have any comments or other feedback.  I'll post it in a few parts since it was a long thirty minute presentation.  Part I is below. Part II Part III

_________________________________________________________________

Intro: As a CRA and Clinical Program Manager I have obtained a mix of pharma & CRO experience. I have worked in all phases of clinical research, I-IV and I have additional experience in regional monitoring & in Clinical Data Management. I am the author of The Lead CRA blog.
In every study as sponsors, we need great relationships to meet our program goals.  It is critical to form an understanding of endpoints in order to obtain quality data.
I am also very interested in your views and would welcome your sharing some of your successes via email or the blog comments.
_________________________________________________________________

Investigators participate in clinical trials for a variety of reasons including scientific interest , professional credentialing, ļ¬nancial remuneration, and as a means to provide new therapeutic options in their clinical practice.
What else motivates investigators to work on trials?
the attributes of the study
the organization running the study
to increase patient base, recruit into their practice
opportunity to consult with experts

Determining the motivators for PI participation in your trial is essential to a good feasibility and site selection initiative. Sponsors must choose the right investigators and also understand how to motivate them.
_________________________________________________________________

Get commitment to the trial for better patient enrollment numbers.
Why do we want relationships with our sites?
incentivize them to prioritize our study
achieve timelines 
have quality data

Your priority must be to make the PI and study staff stakeholders.  Be strategic and focus on the future of your drug development program(s).  There is a huge incremental cost to recruit new investigators at each phase of development.  Work to attract and retain your investigators.  Even if they are one-time investigators, ultimately, they will be the people you will market to in the future to prescribe/buy/promote your drug products. Relationships matter.
_________________________________________________________________

Difficult conversations  are easier to have in the beginning of a study or mid-conduct rather than at the last visit before data lock, or when it is time to sign off on the casebook, or in the context of a sponsor or FDA audit.
Interact before the Investigator Meeting 
Get protocol input 
Avoid capturing the wrong information
Save $$$ by making tweaks before rollout
Are there other sites we should be approaching?
Can you help us develop recruitment and retention materials?
Ask site staff to review CRFs and CRF completion guidelines and edit checks 
Request that your Study Coordinators assist in developing global source documents. This will avoid duplicating information that is obtained in regular clinic chart and head off downstream frustration

Engage beyond the Investigator Meeting
Be present at industry & therapeutic area conferences
Perform ambassador work and actually visit sites
Host teleconferences – invite Study Coordinators to speak and share best practices
Bring Study Coordinators to a destination round-table
Have a face-to-face meeting or "Town Hall"
Institute brainstorming panels (operational feasibility, safety oversight, recruitment strategies)

The Difficult Conversations
When communicating with study site personnel do not allow gripe sessions.  Insist on solution-oriented discussion.  If they have criticisms then ask the question, "What can we do better?"  You should acknowledge that you heard the criticism.  To ensure understanding and alignment, you can re-state the problem or concern before addressing any objections.
_________________________________________________________________

Engage beyond the Investigator Meeting – this is face-to-face SC session done to boost enrollment mid-study; it was held in Vegas at the Four Seasons.
Whenever you interact with your investigators, make reputation management your primary agenda.
Who are we?
How are we to work with?
What do we stand for?

At the face-to-face session pictured above we learned a lot about this specific trial that was struggling to enroll.  After lots of discussion, it turned out most of the Screen Fails were because subjects were not interested in committing to the long/difficult protocol.  The Study Coordinators took turns role-playing with one-another to address participant objections and explain the purpose and objectives of the trial.  They also offered tips and suggestions that allowed our sponsor to create literature and recruitment tools.  The sponsor decided after the meeting to allow re-screening of Screen Failures and more than 10% of the original failures "not interested" were enrolled.  The exercise truly demonstrated that the study team has the greatest influence on a subject’s decision to participate.  This face-to-face meeting really provided a new kick-start to enrollment and brought us closer as a sponsor to the site personnel.

continued in... Part II Part III


You may also like...from The Lead CRA archives:

4 comments:

Anonymous said...

Nadia, thanks for this presentation. Nice simple slides and clear presentation. Q: what are "global source documents" ?
thanks, alexis

NadiaBoBadia said...

I am just referring to sponsor provided source documents that are not site specific. So for example, if every site must perform an ECG and you want to collect the QTC a specific way or calculate an interval using a certain method, it is best to provide a standard source document globally so the data is gathered consistently and available to enter in the CRF as not all ECG machines output results the same way (or you could use centralized ECG but that's another blog post). Another great use of sponsor source documents is on assessment intensive study days. So if the protocol required 20 different activities in a certain order all within a few hours that is a great application of a global source document. You are less likely to have operational deviations if you work the study site through the flow of the visit using a source template.

Anonymous said...

Great information,

I'm currently having to deal with a few difficult non-recruiters, so I'll take those tips on board.

I'm not sure sponsors are allow to provide source documents, we can definitely have an input into it.

I think the regulators do not like seeing sponsors creating the source documents, the CRF's, and then also managing the data.

NadiaBoBadia said...

Hi and thanks for a great comment. I agree that regulators would prefer not to see sponsor provided source. If a PI is truly involved in the trial and understands the protocol they should be willing and able to implement their own source documents. From a monitoring perspective, if many sites use similar source there is some efficincy to be gained but you have to balance that against the risk that something has been inadvertently left out. I discuss this topic further in a post from Apr-2011 on Sponsor Furnished Source Documents.

Post a Comment

Note: Only a member of this blog may post a comment.