Training As A Site Engagement Strategy

Raise your hand if you are a sponsor/CRO that wants to be the organization of choice for investigative sites. Now, raise your hand if you put your sites through endless hours of Web or e-learning training as part of the study start-up process. This is just one of several surefire ways to kill a site’s enthusiasm and commitment to working with you or on your studies. Another, for the record, is sending ill-prepared clinical research associates (CRAs) who are not training specialists to do the PowerPoint death march at site initiation visits (SIVs)!

Sure, we all know ICH GCP guidelines stipulate sponsors should select investigators qualified by training and experience to conduct the trial. But the regulations and guidelines don't prescribe how to conduct the training. Presumably we select experienced investigators, so it has always struck me as odd that we put these highly qualified professionals through rote, mechanical, generic, and, quite often, ineffective training. It goes without saying that the predominant focus of site training should be to ensure the sites learn your protocol. After all, failure of investigators to follow the investigational plan and protocol deviations have consistently been the top FDA clinical investigator inspection findings for decades.¹ In fact, in a 2014 survey of investigative sites conducted by the Society for Clinical Research Sites (SCRS) more than 50 percent of the respondents indicated how sponsors/CROs approach protocol training has a significant impact on the site’s ability to successfully conduct the trial.²  So, effectiveness of protocol training was correlated with successful conduct, which is first and foremost when it comes to ensuring high-quality study implementation.

This same survey found a trend toward more real-time, Web-based training compared to other training methods, but less than 15 percent of respondents reported they were very satisfied with the protocol training the receive from their sponsors/CROs. A more recent survey found sites preferred face-to-face meetings for site training.³ Beyond site preferences, the SCRS survey found that, importantly, sites believe hands-on workshops with opportunities to practice the protocol to be the most effective technique for ensuring protocol understanding. Ensuring training is of high quality, tailored to site needs and preferences, and well-received by the sites should be front and center in terms of your site training strategy. However, all too often, training is relegated to a perfunctory, check-box activity. Beyond training to ensure protocol compliance, learner-centric site training programs should be part of your overall site engagement strategy.

Sites that are engaged are more committed to working on your study and to establishing long-lasting relationships with your organization. In addition to the site selection and budget/contracting process, your training approach is one of the first areas to make a positive impression with sites and differentiate you from the competition. To be more intentional and strategic about your site training approach, here are some key recommendations and resources that address site preferences and requests and build on adult learning best practices.

Create a Site Training Strategy

While a detailed review of all of the elements of a site training strategy is beyond the scope of this article, here are a few considerations:

• Identify the who, what, where, when, why, and how of your training plan.
  • Which site personnel need to be trained on what specific, high-risk, or confusing areas?
  • What prior training can be leveraged (e.g., GCP, CRF) to focus the training on unique aspects of your protocol?
• Determine what can be learned through more passive learning (e.g., self-directed review of recorded slides, online demos) versus things that can only be learned face-to-face (e.g., simulation workshops to translate the protocol into practice using specific job aids, systems).
• Prioritize the investment in face-to-face training so relationship building and shared learning amongst site peers is maximized (i.e., anything that can be handled in other formats should be so this doesn’t detract from precious relationship-building time with your sites).
• Anticipate how new site staff will be trained when there is turnover (e.g., study portals with archived training links) versus just-in-time training with dedicated study team members during subject visits.

For Face-to-Face Training: Investigator/Coordinator Meetings

• Create an engaging room setup — basically anything that is not the traditional classroom style. There are tons of great references for creating engaging environments and setting up rooms to maximize interaction and audience participation.^{4, 5}
• Think about a strategic seating chart whereby sites with different experiences are mixed and matched and study team members rotate throughout the meeting to interact with as many site personnel as possible.
• Build in time for networking to foster critical relationships with site personnel.
• Incorporate basic principles of adult learning theory:
  • aim to appeal to different learning styles (visual, auditory, kinesthetic)
  • recognize people can only process so much information at a time (i.e., 20 minutes max before doing something different)
  • allow time to learn the content, reflect on the content and apply the content (the LRA model).
• Use technology smartly! Intentionally create opportunities for the audience to engage with your content versus their smartphones when presentation of information is necessary.⁶ But, recognize “telling ain’t training” and create engaging, interactive sessions where possible.⁷

For Site Initiation Visits

There’s not much to add, other than raise your hand if you would like to be the recipient of your typical SIV training. I didn’t think so.

Training is critical to setting your sites up for maximum study success, accelerating their protocol learning curve, enhancing their likelihood for protocol compliance, and building productive site relationships. If you aren’t convinced you need to take a more strategic approach to your site training activities for the purpose of engaging your sites, then consider if it’s actually working to prevent those dreaded protocol deviations. Unless you are achieving zero defects in your study execution, there are probably opportunities to enhance your site training. And, if you are, please share your success stories with us in the Comments section below!

References:

1. Office of Scientific Investigations & Office of Study Integrity and Surveillance – BIMO Metrics 2017. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM438250.pdf
2. The Approach of Protocol Training on Clinical Trial Quality. SCRS White Paper. December 2014.  http://myscrs.org/learningcampus/white-papers/
3. Eastbrook, J., et al. Enhanced Site Training, Resources, and Communication. Applied Clinical Trials. March 2, 2016. http://www.appliedclinicaltrialsonline.com/enhanced-site-training-resources-and-communication-during-clinical-trials-site-staff-perspectives?pageID=1
4. Silberman, M. 101 Ways to Make Training Active. https://www.amazon.com/101-Ways-Make-Training-Active/dp/0787976121
5. Summit Management Services: Presenter in the Center room setup. https://summitmgt.squarespace.com/presenter-in-the-center/
6. Summit Management Services: Second Screen Technology. https://summitmgt.squarespace.com/second-screens/
7. Telling Ain’t Training Podcast. https://www.learningrevolution.net/harold-stolovitch-telling-aint-training/

About The Author:

Beth Harper is the president of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. Harper also is the workforce innovation officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Harper is an adjunct assistant professor at George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment, and sponsor-site relationship management. She serves on the CISCRP Advisory Board and the Clinical Leader Editorial Advisory Board, among other industry volunteer activities.

Harper received her B.S. in occupational therapy from the University of Wisconsin and an M.B.A. from the University of Texas. She can be reached at 817-946-4728, bharper@clinicalperformancepartners.com, or bharper@acrpnet.org.