Site Empowerment Q&A with Beth Harper

Beth Harper
President, Clinical Performance Partners, Inc.
February 6th, 2015

We had an overwhelming response to our January webinar, Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs. As a follow-up, here are answers to some of the most popular questions.

Q: I think it’s really interesting for sites to take more ownership of their own performance reports. Do you have some recommendations on the best type of metrics that sponsors and CROs are interested in?

A: Fundamentally there are three key metrics that sponsors and CROs are interested in:

  1. Cycle times and timeliness (e.g., how quickly can your site get up and running; how quickly you can get patients enrolled and can get data in)
  2. Quality (how compliant your site is with the protocol and GCPs – metrics related to compliance fit in here)
  3. Performance and productivity (how accurate you are in your enrollment predictions – actuals vs. planned; how efficient you are in screening or the conversion of screened to randomized patients, for example)

Capturing this data in a systematic way can pose a challenge for some sites, but that’s where a CTMS can come in particularly handy. Even better, sites with a CTMS can leverage the power of this through sharing of their performance data through Nimblify Site Benchmarks. This is a great way to aggregate your metrics, generate easy-to-read reports, benchmark your performance against other sites, and look at your progress over time. I encourage all sites to join and participate in the discussions on how to continue to advance the reporting capabilities of RRN.

Q: How do you handle the “training” from a site monitor who is not qualified to even conduct the trial and is expected to be our resource throughout the trial? This is our biggest problem.

A: I may not be able to address this directly, but fundamentally, one of the site empowerment principles we discussed in the webinar was the need for sites to take ownership of their own training so they are not dependent on the training skills or experience of the monitors. Check out the blog post in which we discussed training techniques. It’s important to recognize that everyone has at some point in their career been new or inexperienced, and we all have to learn our roles. Further, even the most seasoned and experienced CRA may not be a particularly good trainer, or they may not have received good training tools and materials from their sponsor or CRO. Adopting some of the techniques described in the blog post (such as doing your own mock protocol “dry run”) will ensure that you have a clear understanding amongst your staff in the areas that need further clarification. Sharing this proactively in advance allows the CRA to get the questions answered. Having a well-defined communication plan and escalation path can also help ensure that if the CRA isn’t able to address the questions, your site knows who you can contact for more information.

Q: A lot of your suggestions were very good, but we are so busy, we really don’t have time to implement. Where should we start and in particular, and what should new sites focus on?

A: I certainly appreciate the challenge, but if you stop and think about it, how much time do you currently spend in re-work, escalation, troubleshooting, follow-ups and so forth? At some point you have to make an investment in time and resources to change things for the long run. Every site may have a different priority in terms of where to focus. If you find, for example, that you are spending several hours following up on requests as to where things are during the IRB approval and budget and contract process, then proactively sharing your timeline and process with the sponsor and CRO may preempt having to keep explaining why it’s taking so many weeks to get something done, because they will know this up front.

As for new sites who may not have a long history of performance metrics to share, or may not yet have gone through a lot of monitoring visits to know where and how to create proactive monitoring visit agendas, then I would suggest focusing on the two key areas where sites are often faced with issues: enrollment and compliance. I would recommend investing a lot in the site training techniques and development of a proactive recruitment resource plan.

Q: I’m very interested in the idea of a Recruitment Resource Plan.  Where can I get more information about this and are you willing to share your form with us?

A: I’m more than happy to share examples with anyone. Please feel free to contact Beth directly for examples or for additional information. She can be reached at bharper@clinicalperformancepartners.com or 817-946-4782.

Be sure to check out the additional Q&A follow-up articles from Beth Harper on reverse feasibility questionnaires and standard site profiles.

Learn More

To learn more about site empowerment techniques, you can find all of the articles here. Missed the webinar? View it now.

 

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