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

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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.

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Investigators participate in clinical trials for a variety of reasons including scientific interest , professional credentialing, financial 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.

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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.

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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.

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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:

• Selecting Qualified Investigators April 2010
• Investigative Site Recruitment Plan Sep 2010
• Sponsor Furnished Source Documents  April 2011