Secret Formula to be the Best Clinical Trial Site

The Best Clinical Trial Sites are Empowered

The best clinical trial sites have laser-focus on the ultimate goal to advance treatment options for their patients. The best sites perform all trial activities and procedures with the highest attention to quality and adherence.  Sponsors will reward for this performance and clamor to work with these sites again on future trials.

Clinical trial sites are most effective when the individual study staff are empowered to make decisions and take actions that improve the working relationship with sponsors and CROs.  Empowerment is the secret ingredient of the best clinical trial site.

Interact in New Ways and Control the Conversation

In a recent webinar and six-part blog post series for Forte Research, Beth Harper, President of Clinical Performance Partners, gave practical tips and tools that can help any site become the best clinical trial site during the site selection and start-up phase of a clinical trial.

CPPI the best clinical sites

Beth introduces us to the concept of empowerment.  Every clinical trial site can “set themselves up for success” by giving each staff member authority to interact in new ways with the sponsor and CRO.

Empowered study site staff can Improve their relationship with sponsors and build more positive CRO interactions.

These creative approaches make a lot of sense.  Read more in the list below and review the full info at the Forte Research blog.

The Study Sponsor is the Customer

In her talk, Beth says the key is to change the conversation away from a one-sided relationship where the sponsor or CRO control the entire feasibility process.  When you receive a questionnaire or an email inquiry, feel empowered to communicate outside of that questionnaire and to take the thread in a direction that helps you gather more information for determining “fit”.  Put your best foot forward and answer those questions in a way that builds a relationship, don’t just hit ‘Submit’ and let the site survey be a one-sided transaction. Know with confidence the trial makes sense for your site and then respond.

If a trial site wants to showcase their sites special qualifications and relevant experience (even if the sponsor and CRO don’t ask), then they could package it up (on a pen drive or YouTube!) and send it to the decision makers for review and site selection.

Do a reverse feasibility questionnaire

  • The reverse feasibility questionnaire process allows the best clinical trial site to answer this question: “Do we have all the insights available we need to determine if this study is a fit.
  • At ClinOps Toolkit, we would encourage you to at least ask these questions in your reverse feasibility questionnaire:
    • Do I have access to this patient population?
    • Do I have studies competing for this same population?
    • What recruitment accrual rate is acceptable to the sponsor?
    • Am I interested in the science behind this new investigational product or the company doing the research?
    • Do my staff have the capacity to operate this trial correctly?

Showcase site capabilities

  • We like the idea of a “site tour” video introducing the staff, showing the facilities, and marketing performance metrics in a proactive site capabilities brochure, or produce a Transcelerate site profile form.
  • Research Resonance Network by Forte Research allows you to compare your performance with other sites and produce your own performance metrics report card.forte research resonance network
  • Put together a site Recruitment Resource plan and provide actual metrics from previous marketing campaigns.
  • Describe upcoming enhancements or new processes at your site.
Use operational metrics to illustrate your site performance

Use operational metrics to illustrate site performance

CRAs can help throughout the study to Empower Sites

Proactive SIV agenda

  • CRAs, before your SIV, let the site know that you are there to answer their questions and that you are willing to relay their operational or protocol suggestions to the sponsor.  Even sites that are new to clinical research can provide valuable operational input on protocol design.
  • Explain who needs to be at the visit (research pharmacist, lab technician, others who were not at IM but have important study responsibilities).
  • Encourage your sites to thoughtfully review the protocol and do a protocol dry-run in order to prepare questions in advance.
  • Ask site staff to be prepared to discuss design objections and barriers or risks to successful execution of the protocol.
  • When we watched the webinar, we loved an example Beth gave of an unlucky CRA who was asked to present 360 slides at an SIV (doesn’t sound like that monitor was set up for success!). Pare it down, what are the top 10 things you want covered during the visit? Ask the site in advance if there is anything they would like your presentation to focus on.
  • Be prepared to give demonstrations of procedures and bring with you sample lab kits or Investigational Medicinal Product packaging and accountability forms or have them shipped to arrive at the site before you get there.
  • We recommend that you request that the Medical Monitor or a sponsor representative attend the visit.

Demonstrate great customer service to your sites and remind them that the sponsor is their customer

What Beth calls “empowerment” in our opinion, really boils down to exceptional customer service.  She says to sites, the “sponsor is your customer; they need high-quality data in a timely fashion.”  We think as monitors, the study sites are our customer.  It is our responsibility to help them meet the needs of the trial and the sponsor.

 Sites: start a conversation with your customer, the Sponsor/CRO.

You know what your customer wants and you are well within your rights to determine how you can delight them. What do they need, when do they need it, how do they want it, and what does a supremely successful partnership look like?

The Best Clinical Trial Sites Start Things Well…then Work to Continue Well

This Site Empowerment  Webinar (link) was packed with proactive techniques to improve sponsor/CRO relationships during feasibility and start-up.

Over 200 participants completed a survey before the webinar. Many have shown interest in implementing these tools at the start of the trial.  It’s also important to have value-adding activities during the actual study conduct.

Beth’s ideas around investing resources for creating proactive monitoring visit agenda and follow-up summaries are especially interesting but were not the primary focus of the webinar.  At ClinOps Toolkit, we are looking forward to a future series with additional tools to foster better relationships with Sponsors/CROs during conduct.

The Best Clinical Trial Sites will NOT “Leave it to the Monitor”

More productive monitoring visits occur when clinical trial sites partner with the CRAs.  The best clinical trial sites have a lot of influence over how these oversight visits are managed and conducted.

Take ownership of your own compliance and don’t depend on CRA to outline the next actions for you.

Let’s address the benefits of fostering Sponsor and CRO relationships through the entire duration of a trial. Collaborating on clinial studies typically lead to at least several months and more typically several years of interactions.

Just because you know how to start things off in the right direction, doesn’t mean you know how to navigate obstacles and keep nurturing your relationship with the Sponsor/CRO.  How will you be more equipped to respond to data cuts and be inspection-ready at all times?

Your Ideas for a Sponsor/CRO Relationship Toolkit

forte CTMS clinical trial sitesA lot of time and resources go into selecting sites (something that could be more automated and with lower costs) but we don’t run clinical trials just to train clinical trial sites to conduct research or help them build their book of new business. The point of employing the clinical trial site is to achieve meaningful outcomes for our patients. 

We run studies for the benefit of the human clinical trial participants and to learn more about new investigational products.  When clinical trial sites focus on extraordinary quality, sponsors will be paying attention and recognizing that great work.

Sponsor and CROs want the best clinical trial data available to answer the most important protocol questions and help gather data to support marketing applications for new drugs and devices.

Together, with your comments and responses, we can build a toolkit for improving sponsor/CRO relationships throughout the conduct and ultimate close-out of a trial.

  • How will you get “all hands on deck” to delight your sponsor when you face recruitment challenges?
  • How will you better prepare for routine monitoring visits?
  • How can you be sure you have the best clinical trial site data?
  • How will you review study progress and identify opportunities to improve processes through corrective actions?

What questions do you want answered next?  What ideas do you have for your ClinOps Toolkit?

 

About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.